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GlycoMark Compendium of Evidence

Glycemic Control

No. Title Institute Department First Author Citation 1 Variations of 1-Deoxyglucose (1,5-Anhydroglucitol) National Defense Pediatrics Yoshioka S Clin.Chem 1983; 29(7): 1396-1398 content in patients with -dependent Medical College mellitus 2 Reduction and recovery of plasma 1,5-anhydro-D-glucitol University of Teikyo Internal Medicine Yamanouchi T Diabetes 1987; 36(6): 709-715 level in diabetes mellitus 3 Reduction of plasma 1,5-AG(1,5-Anhydroglucitol) levels in Saitama Medical Internal Medicine Kawazu S J. Japan Diab. Soc. 1988; 31(8): diabetes mellitus and renal glycosuria School 715-718 4 Urinary excretion of 1,5-Anhydro-D-glucitol Institute for Diabetes Akanuma Y Diabetologia 1988; 31: 831-835 accompanying excretion in diabetic patients Care and Research, Asahi Life Foundation 5 Reduction of plasma 1,5-anhydroglucitol concentration in University of Teikyo Internal Medicine Yamanouchi T Diabetologia 1988; 31:41-45 diabetic patients 6 Plasma 1,5-anhydro-D-glucitol as new clinical marker of University of Teikyo Internal Medicine Yamanouchi T Diabetes 1989; 38(6): 723-729 glycemic control in NIDDM patients 7 Clinical significance of serum 1,5-anhydroglucitol University of Teikyo Internal Medicine Yamanouchi T J. Japan Diab. Soc. 1990; 33(1): measurements in diabetes mellitus 41-48 8 Serum 1,5-Anhydroglucitol level in patients with non- Jichi Medical School and Iwamoto Y Korea Japan Symp.D.M. 1991; insulin-dependent diabetes Mellitus 117-120 9 1,5-anhydroglucitol as a marker of glycemic control in Jichi Medical School Endocrinology and Ohwada N Clinical Endocrinology 1991; diabetes mellitus. - Its correlation with plasma Metabolism 39(2): 159-161 glucose at present or 2 weeks before - 10 Serum 1,5-anhydro-D-glucitol and glycemic control in Kyushu University Internal Medicine Umeda F Tohoku J.Exp Med 1991; 163: 93- patients with non-insulin-dependent diabetes mellitus 100 11 Plasma 1,5-anhydroglucitol level in diabetes mellitus* Toyama Red Cross Internal Medicine Hiraiwa Y Medical Journal of Toyama 1058, Hospital 22-27, 1991 12 Comparison of 1,5-Anhydroglucitol with several Saiseikai Central Internal Medicine Suzuki Y Jpn J Med Pharm Sci. 1992; 27(3): metabolic parameters in the treatment of Diabetes Hospital 643-647 Mellitus 13 Measurement of serum 1,5-anhydroglucitol in patients Shinshu University Internal Medicine Komiya I J. Japan Diab. Soc. 1992; 35(5): with "near-normal" School of Medicine 385-389 14 Clinical usefulness of 1,5-anhydroglucitol in Diabetes Ota Nishinouchi Diabetes Center Ota S Practice 1992; 9(2): 168-171 mellitus - Utility of 1,5-anhydroglucitol as a glycemic Hospital marker in initial treatment of diabetes mellitus* 15 Estimation of Plasma Glucose Fluctuation with a University of Teikyo Internal Medicine Yamanouchi T Metabolism 1992; 41(8): 862-867 Combination Test of Hemoglobin A1c and 1,5- Anhydroglucitol

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 1 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 16 Clinical usefulness of 1,5-anhydroglucitol in assessing Toshima Hospital Internal Medicine Aiso Y Practice 1992; 9(6): 543-546 treatment effect in insulin treatment for NIDDM*

17 Clinical usefulness of the combination of HbA1c, Saiseikai Central Internal Medicine Hosokawa K Clinic All Round 1992; 41(9): and 1,5-anhydro-D-glucitol as the indices of Hospital 2536-2539 glucose control of diabetes mellitus 18 Clinical significance of serum 1,5-anhydro-D-glucitol Oita Medical Internal Medicine Ito Y Jpn J Med Pharm Sci. 1992; 28(6): measurements in diabetes mellitus University 1307-1314 19 Clinical significance of measurement of serum 1,5- Hyogo College of Clinical and Fujiwara K Medical Consultation and New anhydroglucitol in diabetes mellitus - Especially relation Medicine Clinical Laboratories Remedies 1993; 30(1): 125-133 to nephropathy - 20 1,5-anhydroglucitol, a novel glycemic control marker for Kanda Internal Kanda M Medical Journal of Yamanashi diabetes mellitus* Medicine Clinic 1992; 20:128-132 21 Evaluation of 1,5-AG determination as new marker of Yokufukai Geriatric Central Clinical Takamatsu N Japanese Journal of Medical glycemic control Hospital Laboratory Technology 1993; 42(5): 961-966 22 Changes in plasma and urinary concentrations of 1,5- The Institute for Yoshioka N J. Japan Diab. Soc. 1993; 36(11): anhydro-D-glucitol during oral Diabetes Care and 839-845 Research, Asahi Life Foundation 23 Clinical significance of serum 1,5-anhydroglucitol level in Osaka Prefectural Gastroenterology and Kanda T Medical Journal of Osaka diabetic patients: A study of glucose and calcium General Hospital Metabolism Prefectural General Hospital metabolism 1993; 16(1): 16-20 24 Clinical significance of measurement of serum 1,5- Kinki University Internal Medicine Kishitani Y New Horizon for Medicine 1994; anhydroglucitol* 26(extra I): 884-890 25 Clinical study on changes in 1,5-anhydroglucitol Teramoto Memorial Internal Medicine Yoshikawa T Journal of Clinical Laboratory concentration in plasma Hospital Medicine 1994; 38: 485-488 26 Variations of free non-glucose polyols in serum from National Defense Pediatrics Yoshioka S J. Natl. Def. Med. Coll 1990; 15(4): patients with diabetes mellitus and their correlation with Medical College 217-223 hemoglobin A1c 27 Clinical usefulness of 1,5-anhydroglucitol for evaluating Kyoto Second Red Internal Medicine Okajima Y Medical Consultation & New efficacy of treatment in non-insulin dependent diabetes Cross Hospital Remedies 1994; 31(6): 1073-1078 mellitus. - Especially early marker reflected improvement of glycemic control - * 28 Effect of aging on plasma 1,5-anhydroglucitol levels in Wakayama Medical Internal Medicine Funasako M Diabetes Res. Clin. Pract. 1994; humans and rats College Kihoku 25: 35-41 Hospital 29 Clinical evaluation of serum 1,5AG levels in Diabetics National Kyushu Gastroenterology Wakasugi H Japanese Journal of National Cancer Center Medical Services 1994; 48(1): 32- 35

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 2 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 30 Significance of 1,5-anhydro-D-glucitol in diabetes mellitus Keio University Preventive Medicine and Shimada N Jpn J Ind Health 1993; 36: 448-449 management Public Health 31 The clinical study of the diabetic marker (Centering Tokyo Kosei-Nenkin Central Laboratory Yonekubo I Annual bulletin of Kosei-Nenkin around 1,5-AG) Hospital Hospitals 1993; 20: 381-389 32 1,5-Anhydro-D-glucitol Evaluates daily glycemic Osaka University Internal Medicine Kishimoto M Diabetes Care 1995; 18(8): 1156- excursions in well-controlled NIDDM 1159 33 Significance of combination with in poorly Osaka Prefectural Gastroenterology and Kanda T J. New Rem. & Clin. 1995; 44(10): controlled non-insulin dependent diabetes mellitus General Hospital Metabolism 1699-1705 without obese in therapy* 34 The significance of serum 1,5AG level in outpatients of Tokyo Medical Internal Medicine Notoya Y J. Tokyo Med. Univ 1995; 53(6): non-insulin dependent diabetes mellitus College 842-846 35 Plasma 1,5-anhydroglucitol as clinical marker of diabetic Wu D The Medical Journal of Niigata control City General Hospital 1994; 15(1):13-20 36 Clinical usefulness of serum 1,5-anhydroglucitol in University of Teikyo Internal Medicine Yamanouchi T THE LANCET 1996; 347: 1514- monitoring glycaemic control 1518 37 Efficacy of combination treatment of α-glucosidase Tokyo Medical Endocrinology and Ohno A J. New Rem. & Clin. 1996; 45(6): inhibitor and sulfonylurea in elder diabetic patients* University Hachioji Metabolism 1129-1135 Medical Center 38 Clinical effectiveness of long-term administration of BAY Osaka University Internal Medicine Kawamori R Jpn Pharmacol Ther 1996; 24(5): g 5421 (Acarbose) on insulin-treated diabetes 1109-1129 39 The long-term clinical trial for the evaluation of BAY g Tohoku University Internal Medicine Toyota T Jpn Pharmacol Ther 1996; 24(6): 5421 (Acarbose) combined with sulfonylurea in patients School of Medicine 1375-1392 with NIDDM 40 Beneficial effect of an α-glucosidase inhibitor combined Gracia Hospital Internal Medicine Watanabe N J. Japan Diab. Soc. 1996; 39(9): with conventional insulin therapy in non-insulin- 679-686 dependent diabetics 41 Effect of acarbose on glucose profiles and plasma Nagoya University Internal Medicine Hotta N Biomedicine and 1,5-anhydro-D-glucitol in poorly Pharmacotherapy 1996; 50: 297- controlled by sulfonylurea therapy 302 42 Predicting long-term glycemic control of post-educational University of Tsukuba Endocrinology and Sone H Diabetes Research & Clinical type Ⅱ diabetic patients by evaluating serum 1,5- Metabolism Practice 1996; 34: 83-88 anhydroglucitol levels 43 Clinical significance of measurements of urinary and Dokkyo Medical Pharmaceutical Dept. Inukai T Diabetes Research & Clinical serum thrombomodulins in patients with non-insulin University Koshigaya Practice 1996; 33: 99-104 dependent diabetes mellitus Hospital 44 Clinical evaluation of improving agent Yamaguchi Rosai Kaneko T The Japanese Journal of Clinical AD-4833 in patients with NIDDM controlled by only diet Hospital and Experimental Medicine 1997; therapy - a double-blind, randomized, placebo-controlled 74(6): 1491-1514 test- The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 3 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 45 Clinical evaluation of insulin resistance improving agent Yamaguchi Rosai Kaneko T The Japanese Journal of Clinical AD-4833 in NIDDM patients treated with sulfonylurea - a Hospital and Experimental Medicine 1997; double-blind, randomized, placebo-controlled test-* 74(6): 1515-1539 46 Clinical evaluation of administration of insulin resistance Yamaguchi Rosai Kaneko T The Japanese Journal of Clinical improving agent AD-4833 in combination with voglibose Hospital and Experimental Medicine 1997; in NIDDM patients - Phase III open label study - 74(6): 1540-1556 47 The long-term clinical trial for the evaluation of insulin Yamaguchi Rosai Kaneko T The Japanese Journal of Clinical resistance improving agent AD-4833 in patients with Hospital and Experimental Medicine 1997; NIDDM - A late phase II study on long-term 74(6): 1557-1588 administration -* 48 The long-term clinical trial for the evaluation of insulin Yamaguchi Rosai Kaneko T The Japanese Journal of Clinical resistance improving agent AD-4833 in patients with Hospital and Experimental Medicine 1997; NIDDM - A late phase III study on long-term 74(6): 1589-1613 administration -* 49 Pharmacokinetic study of insulin resistance improving Hiroshima Kouseiren Internal Medicine Takashina S The Japanese Journal of Clinical agent AD-4833 under long-term administration - Hospital and Experimental Medicine 1997; Evaluation of drug concentration in blood and efficacy for 74(6): 1641-1626 glucose -* 50 Rapid improvement of serum 1,5-anhydroglucitol Matsushita Memorial Internal Medicine Yoshioka K Diabetes Care 1997; 20(3): 462 concentrations after administration of α-glucosidase Hospital inhibitor 51 The effect of the acarbose on 1,5-anhydroglucitol level in Mito Kyodo Hospital Metabolism and Boku A Diabetes Frontier 1997; 8: 230- patients with diabetes mellitus* Endocrinology 233 52 Study of the clinical usefulness of α-glucosidase inhibitor Jikei University General Internal Funama K Jpn Pharmacol Ther 1997; 25(8): (voglibose) for the treatment on non-insulin-dependent Medicine 2177-2186 diabetes 53 The effects of α-glucosidase inhibitor, voglibose, on Chita Khosei Hospital Internal Medicine Katagiri K J. New Remedies & Clinics 1997; and diabetes mellitus in patients 46(8): 1098-1104 after gastrectomy 54 Explanation for discrepancy between fasting plasma The Institute for Kikuchi M Japan Medical Journal 1997; glucose and HbA1c* Diabetes Care and 3840: 105-106 Research, Asahi Life Foundation 55 Clinical significance of 1,5-anhydroglucitol in patients Gunma University Internal Medicine Shimizu M Current Therapy 1992; 10(10): with diabetes mellitus - The difference among 1,5-AG , 191-193 HbA1c and fructosamine -* 56 The usefulness of plasma 1,5-AG for a marker of glycemic Kawasaki Medical Endocrinology Tsushima K Kawasaki Med J 1992; 18(1): 21- control in diabetic patients School 24 57 Target level of 1,5-AG in treatment with sulfonylurea* University of Teikyo Internal Medicine Yamanouchi T Japan Medical Journal 1998; 3858: 166

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 4 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 58 Effect of gemfibrozil on glucose tolerance in patients with Saitama Medical Internal Medicine Takahashi K J. Clin. Therap. Med. 1997; 13(15): hyperlipidemia and hyperlipidemia and non-insulin- School 3949-3976 dependent diabetes mellitus 59 Phase-III Study of a novel hypoglycemic agent AY4166, on Siga University of Shigeta Y Clinical Pharmacology and NIDDM patients in Japan (2): Placebo-controlled Medical Science Therapy 1997; 7(5): 729-754 multicenter double-blind study 60 Usefulness of combination therapy with sulfonylurea and Urayasu Hospital of Internal Medicine Iijima T Jpn Phamacol Ther 1997; 25(3): α-glucosidase inhibitor (voglibose) in non-insulin Juntendo University 841-849 dependent diabetes mellitus: Effect of reducing the dose School of Medicine of sulfonylurea 61 Effect of voglibose on glycemic excursions insulin Sasebo Chuou Internal Medicine Matsumoto K Diabetes Care 1998; 21(2): 256- secretion, and insulin sensitivity in non-insulin-treated Hospital 260 NIDDM patients 62 Different effect of acarbose and voglibose on serum 1,5- Ayabe Municipal Internal Medicine Sakane N Diabetes Care 1998; 21(3): 465 anhydroglucitol concentrations Hospital 63 Response to Sakane et al. Matsushita Memorial Internal Medicine Yoshioka K Diabetes Care 1998; 21(3): 465- Hospital 466 64 α-glucosidase inhibitor: a therapeutic use in diabetes Fukuoka University Clinical Laboratory Ono J Clinic All-Round 1998; 47(6): mellitus and the other disorders in glucose metabolism 1862-1867 65 Relationship between serum 1,5-anhydroglucitol and University of Teikyo Internal Medicine Yamanouchi T Diabetes Care 1998; 21(4): 619- urinary excretion of N-acetylglucosaminidase and 624 albumin determined at onset of NIDDM with 3-year follow-up 66 Acarbose Yamashiro Hospital Internal Medicine Nakano K Japanese Journal of Clinical Medicine 1997; 55(extra): 120- 124 67 Combination therapy with sulfonylurea and α-glucosidase Urayasu Hospital of Internal Medicine Iijima T Japanese Journal of Clinical inhibitor Juntendo University Medicine 1997; 55(extra): 186- School of Medicine 191 68 Case report: A GAD positive patient with diabetes Oomiya Medical General Medicine Namai K Diabetes Frontier 1997; 8: 235- mellitus received diet therapy* Center Jichi Medical 243 University 69 A diabetic case with hemoglobin J-Meerut and low HbA1c Tokai University and Yagame M Internal Medicine 1997; 36(5): levels School of Medicine Metabolism 351-356 70 (AD-4833) ameliorates insulin resistance in Osaka University Internal Medicine Yamazaki M Tohoku J.Exp.Med. 1997; 183: patients with NIDDM 173-183 71 Insulin-like growth factors-Insulin-like growth factor Keio University Pediatrics Hasegawa T Endocrine J. 1998; 45(Suppl): binding axis and diabetic control in insulin- School of Medicine S129-S131 dependent diabetes mellitus

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 5 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 72 Effect of α-glucosidase inhibitor on plasma 1,5- Kurihara Clinic Kurihara Y Practice 1998; 15(1): 81-85 anhydroglucitol level* 73 Case report: A patient with continuous high Ebara Hospital Internal Medicine Soeda H Diabetes Frontier 1998; 9(6): 779- level hospitalized for * 786 74 Case report: A difficult case with maintaining good Kanto Chuou Hospital Metabolism Hayashi M Diabetes Frontier 1999; 10(1): glycemic control for a professional reason 135-141

75 Insulin-sensitizing agent University of Teikyo Internal Medicine Yamanouchi T Japanese Journal of Clinical Medicine 1999; 57(3): 675-680 76 Discrepancy between HbA1c and 1,5-AG* University of Teikyo Internal Medicine Yamanouchi T Doctor Salon 1999; 43(7): 553-557 77 Plasma 1,5-anhydroglucitol compared to glycosylated Matsuyama Red Internal Medicine Yamauchi Y Ehime Medical Journal 1999; hemoglobin as clinical markers for diabetes in first-time Cross Hospital 18(4): 540-543 patients 78 Serum 1.5-anhydro-D-glucitol as a new clinical marker for Shanghai Medical Diabetes Research Hongli SHI Chinese Medical Journal 1999; glucose metabolism in type2 diabetes University Department 112(6): 571-573,1999 79 Utility of voglibose long term combined therapy in non- Ehime Prefectural Internal Medicine Fujii Y Japanese Journal of Medicine and insulin dependent diabetic patients with little effective of Central Hospital Pharmaceutical Science 1999; sulfonylurea 42(1): 121-129 80 Effect of "Rensen " on disorders of glucose Isogo Chuou Hospital Healthcare Tsuchida T Medical Consultation & New metabolism* Remedies 1999; 36(6): 481-484 81 Effect of restricted physical activity on glycemic control in Nagaoka Red Cross Medicine and Diabetes Kamoi K J. Japan Diab. Soc. 2000; 43(6): a type-1 diabetic patients with the mitochondrial DNA Hospital Center 477-481 3234 (A to G) 82 Comparison of clinical effect between acarbose and Yamashiro Hospital Internal Medicine Nakano K Practice 2000; 17(1): 73-79 voglibose in type 2 diabetes - crossover study - * 83 Glycemic control state of diabetes outpatients* Jyuzen General Central Clinical Shiomi A The Ehime Journal of Medical Hospital Laboratory Technology 1997; 16: 57-59 84 Oral glucose tolerance test in sixty gastrectomized Institute of Industrial Health Policy and Kaji H J. Japan Diab. Soc. 2001; 44(7): subjects with reference to and Ecological Management 549-554 Sciences 85 Effect of Nateglinide on uncontrolled type 2 diabetes Tokyo Medical Center Internal Medicine Koyama K J. New Rem. & Clin. 2001; 50(4): treated with diet* 419-423 86 Dosage selection of sulfonylurea in changing from Teikyo University Internal Medicine Sekine N J. New Rem. & Clin. 2001; 50(7): glibenclimide to Glimepiride* 717-724 87 Usefulness of data analysis system for diabetic control Juntendo University Endocrinology and Fujita A Practice 2001; 18(1): 74-80 "Medisafe data vision" * School of Medicine Metabolism

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 6 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 88 Post-load glucose measurements in oral glucose Teikyo University Internal Medicine Yamanouchi T Clinical Science 2001; 101: 227- tolerance tests correlate well with 1,5-anhydroglucitol, 233 an indicator of overall glycaemic state, in subjects with impaired glucose tolerance 89 A double-blind trial on the effects of atorvastatin on Tokyo Medical and Internal Medicine Tanaka A Clinica Chimica Acta 2001; 312: glycemic control in Japanese diabetic patients with Dental University 41-47 hypercholesterolemia 90 Effect of Chinese herbal medicine (Ginseng Radix Rubra Nishiarai Hospital Internal Medicine Kim M J. New Rem. & Clin. 2001; and -Qi Pill ) - Retrospective study using FPG, 50(11),1147-1153 HbA1c and 1,5-AG as glycemic marker* 91 Educational hospitalization programs for diabetes Sapporo City General Rehabilitation Shimizu K The Hokkaido Journal of Physical patients by Sapporo General Hospital; Effectiveness of Hospital Therapy 2001; 18: 33-39 short-term physical for type 2 diabetes mellitus 92 replacement therapy and glucose Fukuoka City Infection Center Kohno H Annual report of Foundation for metabolism* Pediatric Hospital Growth Science 2001; 24: 219-221 93 1,5-anhydroglucitol as clinical marker of diabetic control Shizuoka General Clinical Laboratory Amemiya N Shizuoka J Med 2001; 16(1), 67-73 Hospital 94 The effect of high diet on glucose tolerance Yamanashi Medical Internal Medicine Komiyama N Diabetes Res Clin Pract 2002; in patients with type 2 diabetes mellitus University 57(3): 163- 170 95 Clinical heterogeneity in elderly patients with diabetes Osaka University Aging Fujisawa T Jpn J Geriat 2002; 39(4): 390-392 mellitus 96 Attempt of at-home medical care using measurement Li Internal Medicine Li G Practice 2002; 19(1): 89-93 device for urinary glucose, "Well You" and FAX Clinic communications system* 97 Serum 1,5-Anhydroglucitol (GlycoMark TM): A short-term University of North Endocrinology Buse JB Diabetes Technology & glycemic marker Carolina School of Therapeutics 2003; 5(3): 355-363 Medicine 98 Usefulness of troglitazone administration to obese Teikyo University Internal Medicine Sekino N Diabetes Obes Metab 2003; 5(3): hyperglycaemic patients with near-normoglycaemia 145-149 99 Changing HbA1c and 1,5-anhydro-D-glucitol in diabetic Osaka Red Cross Clinical Laboratory Yamada M Japanese Journal of Medicine and patients Hospital Pharmaceutical Science 2002; 47(3): 475-479 100 Glycated albumin (GA) is highly useful as a glycemic Funayama Clinic Funayama H J. Jap Diab. Soc. 2003; 46(5): 375- control marker compared with HbA1c under insulin 379 treatment diabetes mellitus (DM) patients 101 Changing serum urinary acid in type 2 diabetic patients Tokyo Medical Endocrinology and Ohno A Prog. Med. 2004; 24: 755-759 under inpatient management University Hachioji Metabolism Medical Center

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 7 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 102 Circulating 1,5-Anhydroglucitol levels in adult patients Washington McGill JB Diabetes Care 2004; 27(8): 1859- with diabetes reflect longitudinal changes of glycemia University School of 1865 Medicine 103 Diabetic renal hypouricemia Teikyo University Internal Medicine Yamanouchi T Kidney and Dialysis 2003; 55(2): 353-356 104 Effect of hot spring water drinking on glucose Hokkaido University Health Administration Ohtsuka Y Journal of the Japanese Society of metabolism Center Balneology, Climatology and Physical Medicine 2003; 66(4): 227-230 105 Postprandial plasma level is associated with Teikyo University Internal Medicine Kawasaki T Metabolism 2004; 53(5): 583-588 in patients with type 2 diabetes 106 Effect of antidiabetic medications on in Nerima General Internal Medicine Yanagawa T Metabolism 2004; 53(3): 353-357 patients with type 2 diabetes Hospital 107 Different effects of two α-glucosidase inhibitor, acarbose Juntendo University Internal Medicine Watanabe K J Diabetes Complications 2004; and voglibose, on serum 1,5-anhydroglucitol (1,5AG) School of Medicine 18(3): 183-186 level 108 Case Report; Delayed increase of serum pancreatic Wakayama Medical Internal Medicine Nakao T J. Japan Diab. Soc. 2005; 48(8): with onset of a fulminant University 627-631 mellitus* 109 Comparison of metabolic effects of pioglitazone, Teikyo University Internal Medicine Yamanouchi T Diabetic Medicine 2005; 22(8): , and glimepiride over 1 year in Japanese 980-985 patients with newly diagnosed Type 2 diabetes 110 Voglibose Nagoya University Internal Medicine Nakamura J Japanese Journal of Clinical Graduate School of Medicine 2005; 63(extra): 457- Medicine 461 111 The application of plasma 1,5-anhydro-D-glucitol for Poznan Univ. Pharmacology Dworacka M markers 2005; 21(3): 127- monitoring type 2 diabetic patients 132 112 Evaluation of 1,5-AG in diabetic patients treated with α- Kawarazaki Hospital Shirahata M Practice 2005; 22(6): 689-694 glucosidase inhibitor* 113 Comparison of effect on glycemic control between Okayama Medical Internal Medicine and Hida K Prog.Med. 2005; 25(8): 2216-2220 Novorapid 30 mix and Novorin 30R* Center Metabolism 114 Factors related to bone metabolism in type 2 diabetes* Itabashi Central Internal Medicine Sasamoto K The Japanese Journal of Clinical General Hospital and Experimental Medicine 2004; 81(9): 1559-1565 115 Endocrinology and metabolic -especially Hokkaido University Health Administration Ohtsuka Y Journal of the Japanese Society of diabetes mellitus - Center Balneology, Climatology and Physical Medicine 2002; 66(1): 21- 22, 116 Efficacy and safety of once daily gliclazide (20mg/day) Juntendo University Endocrinology and Miwa S Endocrine J 2004; 51(4): 393-398 compared with Nateglinide School of Medicine Metabolism

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 8 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 117 Serum uric acid concentrations in type 2 diabetes: its Aichi Medical Gotho M Endocrine regulations 2005; significant relationship to serum 1,5-anhydroglucitol University 39(4): 119-125 concentrations 118 Clinical efficacy of miglitol in type 2 Japanese diabetics Tohoku Kosei Nenkin Internal Medicine Goto Y Jpn Pharmacol Ther 2005; 33(11): with diet alone - Phase II dose response study - Hospital 1099-1111 119 Disproportionately elevated levels in type 2 Poznan University of Pharmacology Dworacka M Int J Clin Pharmacol Ther 2006; diabetic patients treated with sulfonylurea Medical Science 44(1): 14-21 120 Effects of Kurozu Moromi Powder and Kurozu Sakamoto Brewing Nagano M Jpn Pharmacol Ther 2006; 34(2): concentrated liquid on Co., Ltd. 199-206 121 Prevalence and correlates of post-prandial Piazzale Stefani Bonora E Diabetologia 2006; 49: 846-854 hyperglycaemia in a large sample of patients with type 2 University Hospital diabetes mellitus 122 1,5-anhydroglucitol and postprandial hyperglycemia as Buse JB Endocrine Practice 2005; 11(Suppl measured by a continuous glucose monitoring system in 1): Abstract#912 patients with inadequately controlled diabetes mellitus 123 Optimizing glimepiride dose in patients with type 2 Teikyo University Internal Medicine Igarashi K Prog.Med. 2006; 26(9): 2257-2262 diabetes by titration from 3 mg/day to 6 mg/day 124 Short term intensive insulin therapy improves insulin National Hospital Metabolism and Ogo A Fukuoka Acta Med. 2006; 97(9): secretion significantly in type 2 diabetic patients Organization Kyushu Endocrinology 277-284 Medical Center 125 The association between glycoxidation and chronic or Poznan University Pharmacology Dworacka M Int J Diabetes & Metabolism 2006; acute hyperglycaemia in type2 diabetic patients with Medical Science 14(1): 27-31 retinopathy 126 Relationship between 1,5-anhydroglucitol and result of Nippon Medical geriatrics Ohba K Summary Control Report 2006 carotid ultrasound in elderly patients -cross School sectional study in non-diabetic patients - * 127 Pro-Atherogenic alterations in T-Lymphocyte Pozan University Pharmacology Dworacka M Circulation Journal 2007; 71: 962- subpopulations related to acute hyperglycaemia in type 2 Medical Science 967 diabetic patients 128 Evaluation of glucose lowering effects of mitiglinide in Yokohama City Graduate School of Tanaka S Jpn Pharmacol Ther2007; type 2 diabetes patients University Clinical Research 35(supplement): S5-S21 129 Hyperglycemia and diabetic renal change in a model of Kyoto University Organ Reconstruction Sakata N 2007; 34(4): 458-465 polyvinyl alcohol bioartificial pancreas transplantation and Biomaterials 130 Voglibose improves postprandial glycemic state , reduces Kyoto Medical Center Sato T Journal of oxidative stress and prevent progression of 2007; 3(1): 62-69 arteriosclerosis* 131 Comparison of glimepiride and mitiglinide in drug-naïve Jichi Medical Endocrinology and Nagasaka S Jpn J Diabet Mast Clin 2007; 5(4): type 2 diabetic patients University Metabolism 395-400

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 9 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 132 Miglitol increases the level and decrease Jiyugaoka Medical Internal Medicine Yokoyama H Metabolism Clinical and urinary albumin excretion in patients with type2 diabetes Clinic Experimental 2007; 56: 1458- mellitus 1463 133 Investigation of rapid-acting insulin analogue (insulin Kurume University Endocrinology Imamura Y J. Japan Diab. Soc. 2008; 51(1): 1- aspart) for CSII School of Medicine 7 134 Does serum 1,5-anhydroglucitol establish a relationship Novo Nordisk Inc., Moses AC Diabetic Medicine 2008; 25(2): between improvements in HbA1c and postprandial 200-205 glucose excursions? 135 Type 1 diabetes mellitus (adult)* Saitama Medical Internal Medicine Maruyama T The Japanese Journal of Clinical Center Nutrition 2000; 97(4): 499-504 136 Effects of mitiglinide on glucose and metabolism in Nippon Medical Internal Medicine Watanabe K Therapeutic Research 2008; 29(5): poorly-controlled type 2 diabetic patients with School 811-819 137 Current strategies for evaluating, monitoring, and Chino Medical Group Unger J Am J Med. 2008; 121(6,suppl): S3- treating type 2 diabetes mellitus Diabetes and S8, 2008 Intervention Center 138 Relationship between 1,5-anhydroglucitol and Fujisawa Municipal Internal Medicine Hoshino K J. Japan Diab. Soc. 2004; 47(11): development of Hospital 845-850 139 1,5-anhydroglucitol and postprandial hyperglycemia as University of North Endocrinology Dungan KM Diabetes Care 2006; 29(6): 1214- measured by continuous glucose monitoring system in Carolina School of 1219 moderately controlled patients with diabetes Medicine 140 Clinical application of 1,5-anhydroglucitol measurements Jagiellonian Metabolic Diseases Skupien J Diabetes Care 2008; 31(8): 1496- in patients with hepatocyte nuclear factor-1α maturity- University 1501 onset diabetes of the young 141 Association of 1,5-anhydroglucitol and 2-h postprandial University Hospital Endocrinology Stettler C Diabetes Care 2008; 31(8): 1534- blood glucose in type 2 diabetic patients Bern 1535 142 Replacement of voglibose by miglitol resulted in further Miura Medical Clinic Miura Y Prog.Med. 2008; 28(9): 2241-2244 improvement of glycemic control in patients with type 2 diabetes 143 Evaluation of self monitoring of blood by an Matsushita Memorial Central Clinical Nakajima Y Japanese Journal of Medical electrochemical sensor in type 1 diabetes patients Hospital Laboratory Technology 2008; 57(5): 823-827

144 Comparison of pre- vs. postmeal administration of Yokohama City Endocrinology and Aoki K Diabetes, and metabolism miglitol for 3 months in type 2 diabetic patients University Metabolism 2008; 10(10): 970-972 145 Association of 1,5-anhydroglucitol and 2-h postprandial Isala Clinics Clinical Chemistry Schindhelm RK Diabetes Care 2008; 31(11): e89 blood glucose in Type 2 diabetic patients 146 Association of 1,5-anhydroglucitol and 2-h postprandial University of Bern Endocrinology Stettler C Diabetes Care 2008; 31(11): e90 blood glucose in Type 2 diabetic patients

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 10 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 147 Relationship of 1,5-anhydroglucitol (1,5AG) to other Ohio State University Dungan KM ADA 68th Annual Scientific baseline characteristics in insulin-Naïve type 2 diabetes Sessions, June 6-10, 2008 (T2D) patients in the DURABLE trial 148 Comparison of twice-daily injections of biphasic insulin Kitasato Institute Diabetes Center Masuda H Diabetes Obes Metab 2008; lispro and basal-bolus therapy: glycaemic control and Hospital 10(12): 1261-1265 quality-of-life of insulin-naïve type2 diabetic patients 149 1,5-Anhydroglucitol reflects postprandial hyperglycemia Sungkyunkwan Internal Medicine Won JC Diab. Res. Clin. Pract 2009; 84(1): and a decrease insulinogenic index, even in subjects with University School of 51-57 and well-controlled type 2 diabetes Medicine 150 Efficacy and safety of sitagliptin monotherapy in Banyu Nonaka K Diabetes Res Clin Pract 2008; Japanese patients with type 2 diabetes Pharmaceutical 79(2): 291-298 Co.,Ltd. 151 Consequences of delayed pump infusion line change in Tulane University Health Sciences Thethi TK Journal of Diabetes and Its patients with type 1 diabetes mellitus treated with Complications 2010; 24: 73-78 continuous subcutaneous insulin infusion 152 Clinical significance of miglitol, new alpha-glucosidase Kurume University Endocrinology Sato S Therapeutic Research 2009; 30(4): inhibitor, to impaired glucose tolerance School of Medicine 517-523 153 Racial and ethnic differences in mean plasma glucose, University of Internal Medicine and Herman WH J Clin Endocrinol Metab 2009; Hemoglobin A1c, and 1,5-Anhydroglucitol in over 2000 Michigan Epidemiology 94(5): 1689-1694 patients with type 2 diabetes 154 , a once-weekly human GlP-1 analogue, Sebokova E Diabetes 2009; 69th ADA reduces postprandial glucose (PPG) levels and provides long-term glucose control in ZDF rats 155 1,5anhydroglucitol concentrations and measures of Kuenen JC Diabetes 2009; 69th ADA glucose control and glucose variability in T1DM and T2DM patients 156 Utility of 1,5-anhydroglucitol(1,5-AG) in assessing Mehta SN Diabetes 2009; 69th ADA glycemia among and adults with type 1 diabetes (T1D) 157 Unfavorable BNP change with the use of Shirabe S Diabetes 2009; 69th ADA in therapy of mild type 2 diabetes patients 158 Glycemia indicators influenced on 1,5-anhydroglucitol Nomura K Diabetes 2009; 69th ADA and hemoglobin A1c among non-diabetic subjects 159 Relationship between long-range correlated glucose Ogata H Diabetes 2009; 69th ADA fluctuation and indices of glucose control humans 160 Relationship between clinical markers of glycemia and St. Marianna Metabolism and Suwa T Endocr.J. 2010; 57(2): 135-140 glucose excursion evaluated by continuous glucose University School of Endocrinology monitoring(CGM) Medicine

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 11 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 161 Relationship between long-range correlated glucose University of Tokyo Ogata H J.Physiol.Sci 2009; fluctuation and indices of glucose control using 59(Supplement1): 333 continuous glucose monitoring 162 Pleiotropic effects of mitiglinide in type 2 diabetes Hyogo College of Diabetes and Konya H Journal of international medical mellitus Medicine Metabolism research 2009; 37(6): 1904-1912 163 The use of 1,5anhydroglucitol level as a clinical test to University of Oxford Diabetes Research Owen KR Diabetologia 2009; 52(Suppl1): differentiate subtypes of diabetes Laboratories S105 164 Postprandial glucose levels and long-term glucose control F.Hoffmann-La Roche Sebokava E Diabetologia 2009; 52(Suppl1): are improved with taspoglutide, a human once-weekly AG S308 GLP-1 analogue, in an animal model of type 2 diabetes 165 BNP elevation following 12-week pioglitazone treatment Shinkawabashi Shirabe S Diabetologia 2009; 52(Suppl1): in patients with type 2 diabetes Hospital S335 166 The influence of needle length on glycaemic control and University Medical Endocrinology Kreugel G Diabetologia 2009; 52(Suppl1): injection-related complaints in obese diabetes subjects Center S377 167 Urinary myoinositol index: a new and better marker for Toho University Diabetes, Metabolism Miyagi M Diabetologia 2009; 52(Suppl1): postprandial hyperglycaemia School of Medicine and Endocrinology S401 168 Is 1,5AnhydroGlucitol associated with malondialdehyde a VU University Diabetes Center Kuenen J Diabetologia 2009; 52(Suppl1): marker for oxidase stress? Medical Center S500-S501 169 Clinical significance of 3 times-daily administration of Toho University Diabetes and Kawana H Prog.Med. 2009; 29(11): 2669- Humalog Mix 50 (50% and 50% insulin lispro School of Medicine Endocrinology Center 2672 protamine suspension injection) * 170 Evaluation of serum 1,5 anhydroglucitol levels as a University of Oxford Diabetes Research Pal A Diabetes 2010; Care 33(2): 252- clinical test to differentiate subtype of diabetes Laboratories 257 171 Association between diabetes-related distress and University South Medicine Coleman SR Canadian Journal of Diabetes postprandial hyperglycemia in patients with diabetes Caroline School of 2009; 33(3): 238 Medicine 172 Serum uric acid levels positively correlated with serum Kinki Central Hospital Health Care Center Koga M Official Journal of Japan Society of 1,5-anhydroglucitol levels in patients with type 2 diabetes Ningen Dock 2010; 24(5): 40-44 mellitus 173 Evaluation of 1,5-anhydroglucitol as a marker for glucose Kim MJ Diabetes 2010; (70th ADA) variability in patients with type 2 diabetes mellitus 174 1,5-anhydroglucitol, but not fructosamine or HbA1c, Liu L Diabetes 2010; (70th ADA) predicted glycemic remission in patients of newly diagnosed type 2 diabetes treated with short-term intensive insulin therapy 175 Utility of 1,5-anhydroglucitol (1,5AG) for guiding insulin Dungan KM Diabetes 2010; (70th ADA) therapy in type 2 diabetes (T2D) patients (Pts) with suboptimal control on oral antidiabetic agents

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 12 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 176 Evaluation of relationship between postprandial glucose Watanabe K Diabetes 2010; (70th ADA) level and progression of in normal glucose-tolerant patients with of dyslipidemia by using carotid ultrasound variables and serum 1,5-anhydroglucitol (1,5-AG) 177 Black-white differences in hemoglobin A1c (HbA1c) and Selvin E Diabetes 2010; (70th ADA) other glycemic markers 178 1,5-anhydroglucitol level is a useful marker reflects the Kanda J Diabetes 2010; (70th ADA) early response for miglitol therapy in type 2 diabetic patients 179 A novel new glycemic variability metric Schwartz FL Diabetes 2010; (70th ADA) 180 The investigation of daily profile of blood glucose Miura J Diabetes 2010; (70th ADA) analyzed with CGMS in well-controlled with Type 1 diabetes between with and without unaware severe 181 Clinical use of 1,5-AG (Glycomark) in isle transplantation Gracia MIDO Diabetes 2010; (70th ADA) 182 Dose-ranging efficacy of sitagliptin, a dipeptidyl Tokyo Women's Diabetes Center Iwamoto Y Endocr J 2010; 57(5): 383-394 peptidase-4 inhibitor, in Japanese patients with type 2 Medical University diabetes mellitus 183 Efficacy and safety of sitagliptin monotherapy compared Tokyo Women's Diabetes Center Iwamoto Y Diabetes Obes Metab 2010; 12, with voglibose in Japanese patients with type 2 diabetes: Medical University 613-622 a randomized, double-blind trial 184 1,5-anhydroglucitol levels are associated with Yokohama City Otsuka F Circulation Journal 2010; postprandial hyperglycemia and coronary artery disease University Medical 74(Suppl.1): 300 in non-diabetic subjects Center 185 Lower levels of serum 1,5-anhydroglucitol (1,5-AG) are Disaster Medical Cardiovascular Medicine Kato R Circulation Journal 2010; associated with acute coronary syndrome (ACS) Center 74(Suppl.1): 481-482 186 Improvement of postprandial hyperglycemia and arterial Sakura Hospital Center of Diabetes Ohira M Metabolism Clinical and stiffness upon switching from premixed human insulin Medical Center, Toho Experimental 2010; 60: 78-85 30/70 to biphasic 30/70 University 187 Serum 1,5-anhydroglucitol levels in patients with Kinki Central Hospital Internal Medicine Koga M Clinical Biochemistry 2010; 43: fulminant type 1 diabetes are lower than those in 1265-1267 patients with type 2 diabetes 188 Single administration of α-glucosidase inhibitors on Juntendo University Cardiovascular Medicine Hiki M Circulation Journal 2010; 74: endothelial function and secretion in diabetic School of Medicine 1471-1478 patients with coronary artery disease 189 added to -treated patients with International Bergenstal RM Diabetologia 2010; 53(Suppl1): type 2 diabetes provided excellent fasting and Diabetes Center S37 postprandial control with and no increased risk of hypoglycaemia

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 13 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 190 Efficacy of miglitol on postprandial glucose control Jichi Medical Endocrinology and Nagasaka S Diabetologia 2010; 53(Suppl1): assessed by continuous glucose monitoring University Metabolism S362 191 The DURABLE Trial: comparing durability of lispro mix 25 University Medical Endocrinology Wolffenbuttel Diabetologia 2010; 53(Suppl1): vs. glargine Center Groningen BHR S383 192 1,5-Anhydroglucitol as a marker of short term glucose Kyung Hee University Endocrinology and Lee YJ Diabetologia 2010; 53(Suppl1): variability in well-controlled type 2 diabetes mellitus Hospital Metabolism S399 193 An information-motivation-behavioral skills analysis in University of Western Psychology Kohut T Diabetologia 2010; 53(Suppl1): frequent testers Ontario S419 194 Taspoglutide, a novel human once-weekly analogue of F. Hoffmann-La Sebokova E Diabetes, Obesity and Metabolism glucagon-like -1, improves glucose Roche AG 2010; 12: 674-682 and body weight in the Zucker diabetic fatty rat 195 Correlation between baseline serum 1,5-anhydroglucitol National Center for Diabetes and Metabolic Goto M Endocr J 2011; 58(1): 13-17 levels and 2-hour post-challenge glucose levels during Global Health and Medicine oral glucose tolerance tests Medicine 196 The efficacy on 1,5-anhydroglucitol (1,5AG) as a marker Mejiro Medical Clinic Hisano N Japanese Journal of Medicine and of postprandial hyperglycemia by DPP-4 inhibitor Pharmaceutical Science 2010; sitagliptin 64(4): 589-592 197 Long-term treatment of miglitol ameliorate dyslipidemia Misaki Naika Clinic Kuribayasi N Therapeutic Research 2010; and fatty in diabetic outpatients 31(11): 1617-1623, 2010 198 Case report; A fulminant type 1 diabetes mellitus Tokyo Medical and Molecular Endocrinology Miyake A J. Japan Diab. Soc. 2011; 54(2): developed during hospitalization for impaired Dental University and Metabolism 107-111 consciousness* 199 Racial difference in glycemic markers: A cross-sectional Johns Hopkins Epidemiology and Selvin E Ann Intern Med 2011; 154(5): analysis of community-based data Bloomberg School of Clinical Research 303-309 Public Health 200 Lower levels of serum 1,5-anhydroglucitol are associated 災害医療センター Cardiovascular Medicine Ito J JACC 57 2011; (Supplement1): with non-diabetic patients with acute coronary syndrome E937 201 Serum 1,5-anhydro-D-glucitol levels predict first-ever National Cerebral and Preventive Cardiology Watanabe M Atherosclerosis 2011; 216: 477- : An 11-year population-based Cardiovascular Center 483 cohort study in Japan, the Suita study 202 Nontraditional markers of glycemia - Associations with Johns Hopkins Epidemiology Selvin E Diabetes Care 2011; 34: 960-967 microvascular conditions Bloomberg School of Public Health 203 Randomized trial on the influence of the length of two University Medical Endocrinology Kreugel G Diabetes Technology & insulin pen needle on glycemic control and patient Center Groningen Therapeutics 2011; 13(7): 737-741 preference in obese patients with diabetes

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 14 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 204 Treatment with the α-glucosidase inhibitor miglitol from University of Laboratory of Nutrition Mochizuki K Metabolism 2011; 60(11): 1560- the preonset stage in Otsuka long-evans Tokushima fatty Shizuoka Physiology 1565 rats improves glycemic control and reduces the expression of inflammatory in peripheral leukocytes 205 Relationship between postprandial hyperglycemia and Ouchi M American Diabetes Association renal tubular function in patients without diabetes 2011; (71st) 206 Is 1,5Anhydroglucitol(Glycomark) a clinically useful test in Duran-Valdez E American Diabetes Association type 1 diabetes? 2011; (71st) 207 Relationships between glycemia, oxidative stress and Jenkins AJ American Diabetes Association in type 1 diabetic patients using insulin 2011; (71st) pumps 208 Clinical Evaluation of DPP-4 inhibitor vildagliptin* Ayame Clinic Ayame H J. New Rem. & Clin. 2011; 60(8): 1569-1575 209 Comparison of efficacy of concomitant administration of Hyogo College of Diabetes and Katsuno T J. Diabetes Invest. 2011; 2(3): 204- mitiglinide with voglibose and double dose of mitiglinide Medicine Metabolism 209 in patients with type 2 diabetes mellitus 210 Efficacy and safety of alogliptin in Japanese patients with Kansai Electric Power Seino Y Current medical research and type 2 diabetes mellitus: a randomized, double-blind, Hospital opinion 2011; 27(9): 1781-1792 dose-ranging comparison with placebo, followed by a long-term extension study 211 The beneficial effect of α-glucosidase inhibitor on glucose Changhua Chistian Endocrinology and Shi-Dou Lin Journal of Diabetes and Its variability compared with sulfonylurea in Taiwanese type Hospital Metabolism Complications 2011; 25, 332-338 2 diabetic patients inadequately controlled with metformin: preliminary data 212 Improvement of postprandial hyperglycemia and arterial Toho University Center of Diabetes, Ohira M Journal of Diabetes 2011: stiffness upon switching from premixed human insulin Medical Center Endocrine and 3(SUPPL1): 267 30/70 to biphasic insulin aspart 30/70 Sakura Hospital Metabolism 213 Plasma 1,5-anhydroglucitol levels as marker of University of Fukui Ishida K European heart journal postprandial hyperglycemia are correlated with severity 32(Suppl.1), 1060 ,2011 of left ventricular dysfunction in patients with acute myocardial infarction 214 Evaluation of 1,5-anhydroglucitol as a marker for Seoul National Internal Medicine Kim MJ Acta Diabetol 2013; 50: 505-510 glycemic variability in patients with type 2 diabetes University College of mellitus Medicine 215 Effects of miglitol in combination with intensive insulin Hyogo College of Diabetes and Nagai E Endocr J. 2011; 58(10): 869-877 therapy on blood glucose control with special reference Medicine Metabolism to incretin responses in type 1 diabetes mellitus 216 A patients with acute lymphoblastic leukaemia Kitasato University Hematology Suzuki Y Ann Clin Biochem. 2011; 48: 474- presenting with an extremely high level (21.0%) of HbA1c School of Medicine 477

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 15 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 217 Close relationship between serum 1,5-anhydroglucitol Kinki Central Hospital Internal Medicine Koga M and Nucleic Acid levels and serum uric acid levels in subjects with normal Metabolism 2011; 35(1): 9-17 glucose tolerance 218 Comparison of a novel insulin bolus-patch with Monteagle Medical Bohannon N Diabetes Technol Ther 2011; pen/syringe injection to deliver mealtime insulin for Center 13(10): 1031-1037 efficacy, preference, and quality of life in adults with diabetes: a randomized, crossover, multicenter study 219 Does measurement of serum 1,5-anhydroglucitol (1,5- Nagoya Heart Center Murase S J.Am.Coll.Cardiol 2011; 58(20): AG) level be able to predict the presence of coronary B169 plaque? 220 Effect of intensive antidiabetic therapy on sleep- Osaka University Metabolic Medicine Kashine S The Japan Atherosclerosis Society disordered breathing in patients hospitalized for poorly Annual Meeting 2011; 43rd: 244 controlled type 2 diabetes mellitus 221 Retrospective cohort study on cardiovascular event in National Cerebral and Preventive Cardiology Miyamoto Y General report in 2010 2011; 84- diabetic patients Cardiovascular Center 85 222 Do α-glucosidase inhibition have potential benefits Jichi Medical Endocrinology and Nagasaka S Jpn J Diabet Mast Clin 2011; 9(4): beyond glucose-lowering effect?* University Metabolism 403-407 223 Effect of sitagliptin on postprandial hyperglycemia* KKR Sapporo Medical Diabetes and Hida Y Practice 2011; 28(3): 320-323 Center Tonan Endocrinology Hospital 224 Effect of periodontal disease treatment on glycemic Gifu Prefectural Diabetes and Yoshino K Prog.Med. 2011; 31(10): 2463- control in diabetic patients* General Medical Endocrinology 2467 Center 225 Selective contribution of waist circumference reduction Osaka University Metabolic Medicine Kashine S Internal Medicine 2011; 50: 1895- on the improvement of sleep-disordered breathing in 1903 patients hospitalized with type 2 diabetes mellitus 226 Effect of 3-month repeated administration of Miglitol on Hyogo Prefectural Cardiovascular Medicine Emoto T The American Journal of vascular endothelial function in patients with diabetes Awaji Hospital Cardiology 2012; 109(1): 42-46 mellitus and coronary artery disease 227 Correlation between 1,5-anhydroglucitol and glycemic Chinese People's Endocrinology Sun J Chinese medical Journal 2011; excursions in type 2 diabetic patients Liberation Army 124(22): 3641-3645 General Hospital 228 Metabolomic biomarkers of impaired glucose tolerance Nottingham Medical Galazis N Eur J Obstet Gynecol Reprod Biol. and type 2 diabetes mellitus with a potential for risk School 2012; 160(2): 121-130 stratification in women with polycystic ovary syndrome 229 Plasma 1,5anhydroglucitol levels, a measure of short- University of Medicine Januszewski AS Diabetes Res Clin Pract 2012; 95: term glycaemia: Assay assessment and lower levels in Melbourne e17-e19 diabetic vs. non-diabetic subjects

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 16 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 230 A pilot study of the efficacy of miglitol and sitagliptin for National Center for Diabetes and Metabolic Kishimoto M Cardiovascular Diabetology 2011; type 2 diabetes with a continuous glucose monitoring Global Health and Medicine 10: 115-123 system and incretin-related markers Medicine 231 Metabolomic profiling of patients with new-onset type 1 Connolly Hospital Endocrinology Tisdall AR Ir. J. Med. Sci. 2011; 180: S501- diabetes: an insight into early metabolic changes S502 232 Effect of bile-acid-binding resin (colestimide) on blood Nippon Medical Internal Medicine Suzuki T Journal of Diabetes and its glucose and visceral in Japanese patients with type 2 School Complications 2011; 26: 34-39 diabetes mellitus and hypercholesterolemia; an open- label, randomized, case-control, crossover study 233 Medium-term repeated administration of miglitol Hyogo Prefectural Internal Medicine Emoto T Circulation 2011; 124: A9929 improves vascular endothelial dysfunction in diabetic Awaji Hospital patients with coronary artery diseases - evaluation using Flow-Mediated Dilatation 234 Characterizing blood glucose variability using new metrics Ohio University Electrical Engineering Marling CR Journal of Diabetes Science and with continuous glucose monitoring data and Computer Science Technology 2011; 5(4): 871-878 235 Relationship between serum 1,5-AG levels and Keio University Preventive Medicine and Okamura T General report in 2010 2011:171- macrovascular diseases (coronary artery disease, ) Public Health 175 in Suita cohort study 236 Effect of Sitagliptin on the result of 75g OGTT* Minamikosigaya Shuto H J. Saitama M. S. 2011; 46(1): 139- Kenshinkai Clinic 142 237 Effect of DPP-4 inhibitor (sitagliptin) on glucose Hiramitsu Heart Clinic Hiramitsu N Prog.Med. 2012; 32(2): 337-344 metabolism and heart and renal function in type 2 diabetic patients* 238 Does examination of 1,5-anhydroglucitol (1,5-AG) be able Nagoya Heart Center Cardiovascular Medicine Murase S to predict a coronary artery plaque? Cardiovascular Medicine Annual Meeting of the Cardiovascular Intervention and Therapeutics 2011; 20th: 445 239 The lack of long-range negative correlations in glucose The University of Educational Physiology Ogata H Metabolism Clinical and dynamics is associated with worse glucose control in Tokyo Laboratory Experimental 2012; 61: 1041- patients with diabetes mellitus 1050 240 A study on the association of serum 1,5-anhydroglucitol Zhongda Hospital Endocrinology Wang Y Diabetes Metab Res Rev. 2012; levels and the hyperglycemia excursions as measured by 28: 357-362 Continuous Glucose Monitoring System among type 2 diabetes in Chinese population 241 Serum 1,5-anhydroglucitol is low in gastrectomized men Kinki Central Hospital Internal Medicine Murai J Acta Diabetol 2014; 51(2): 337- 338 242 Serum 1,5-anhydroglucitol is associated with diabetic Kangbuk Samsung Endocrinology and Kim WJ Diabet Med. 2012; 29(9): 1184- retinopathy in type 2 diabetes Hospital Metabolism 1190

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 17 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 243 Potential for use of 1,5-anhydroglucitol when initiating Ohio State University Dungan KM Diabetes Res Clin Pract 96, e66- insulin therapy in people with type 2 diabetes and Medical Center e69, 2012 suboptimal control with oral antidiabetic drugs 244 Effects of sex and age on serum 1,5-anhydroglucitol in Nippon Medical Internal Medicine Ouchi M Exp Clin Endocrinol Diabetes nondiabetic subjects School 2012; 120: 288-295 245 Clinical significance of - Comparison with Osaka City General Metabolism and Hosoi M J. New Rem. & Clin. 2012; 61(3): 3 insulin analog -* Hospital Endocrinology 439-445 246 Effect of vildagliptin on daily blood glucose fluctuation in Taneda Medical Clinic Taneda Y J. New Rem. & Clin. 2012; 61(2): type 2 diabetes* 222-229 247 Clinical effect of DPP-4 inhibitor vildagliptin in type 2 Taneda Medical Clinic Taneda Y J. New Rem. & Clin. 2012; 61(2): diabetes* 231-237 248 Lower levels of serum 1,5-anhydroglucitol in well Tokyo Disaster Cardiovascular Medicine Ito J Circulation Journal 2012; controlled diabetic patients with acute coronary Medical Center 76(Suppl.1): I-1434 syndrome 249 Impact of 1,5-anhydro-D-glucitol on restenosis and TLR in Tokyo Disaster Cardiovascular Medicine Hirasawa K Circulation Journal 2012; patients underwent percutaneous coronary intervention Medical Center 76(Suppl.1): I-2322 250 Membrane type 1-matrix metalloproteinase is a predictor University of Fukui Cardiovasular Medicine Uzui H Circulation Journal 2012; of coronary plaque in patients with postprandial 76(Suppl.1): I-2323 hyperglycemia 251 The safety, efficacy and predictors for HbA1c reduction of Kanagawa Physicians The Study Group of the Maeda H Diabetes Res Clin Pract 2012; 95: sitagliptin in the treatment of Japanese type 2 diabetes Association Diabetes Committee e20-e22 252 Long-term safety and efficacy of exenatide twice daily in Kyoto University Diabetes and Clinical Inagaki N Journal of Diabetes Investigation Japanese patients with suboptimally controlled type 2 Nutrition 2011; 2(6): 448-456 diabetes 253 Alternative markers of glycemia and risk of diabetes in Juraschec SP Diabetes 2012; 61(SUPPL1): A7 the atherosclerosis risk in communities(ARIC) study 254 Vascular health in type 1 diabetes: CSII vs. MDI Januszewski AS Diabetes 2012; 61(SUPPL1): A228 255 The investigation of risk factor for the hypoglycemia Miura J Diabetes 2012; 61(SUPPL1): A554 unawareness in patients with type 1 diabetes using CGMS 256 The efficacy and safety of the combination usage of Togo M Diabetes 2012; 61(SUPPL1): A622 mitiglinide and depeptidyl-peptidase-4 inhibitor sitagliptin 257 Pilot study of caffeine abstinence for control of chronic Duke University Psychiatry and Lane JD Journal of caffeine research 2012; glucose in type 2 diabetes Medical Center Behavioral Sciences 2(1): 45-47 258 Effect of GLP-1 analogue on continuous glucose Tokyo Jikei University Diabetes, Metabolism Mori Y The Journal of Therapy 2012; monitoring* School of Medicine and Endocrinology 94(5): 1009-1011 Kashiwa Hospital

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 18 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 259 Serum 1,5-anhydro-D-glucitol levels predict first-ever National Cerebral and Preventive Cardiology Watanabe M Current Diabetology 2012; 3(3): cardiovascular disease: An 11-year population-based Cardiovascular Center 164-165 cohort study in Japan, the Suita study 260 Clinical efficacy of miglitol as add-on treatments in type 2 Komatsu Clinic Komatsu K Diabetes Frontier 2012; 23(3): diabetes - Changing of glycemic marker and 351-354 microalbuminuria* 261 Effect of increasing DPP-4 inhibitor vildagliptin on Iketani Clinic Iketani T J. New Rem. & Clin. 2012; 61(9): glycemic control* 1764-1768 262 Efficacy and safety profile of exenatide once weekly Kyoto University Diabetes and Clinical Inagaki N Clinical Therapeutics 2012; 34(9): compared with insulin once daily in Japanese patients Nutrition 1892-1908 with type 2 diabetes treated with oral antidiabetes drug(s) 263 Increased 1,5-Anhydroglucitol predicts glycemic Sun Yat-Sen Endocrinology Liu L Diabetes Technology & remission in patients with newly diagnosed type 2 University Therapeutics 2012; 14(9): 756-761 diabetes treated with short-term intensive insulin therapy 264 Comparison of vildagliptin twice daily vs. sitagliptin once Jikei University Diabetes, Metabolism Sakamoto M Cardiovasc Diabetol 2012; 11: 92 daily using continuous glucose monitoring (CGM): School of Medicine and Endocrinology Crossover pilot study (J-VICTORIA study) 265 Miglitol, α-glycosidase inhibitor, reduces visceral fat The University of Cardio-Diabetes Shimabukuro Int J Cardiol 2013; 167(5): 2108- accumulation and cardiovascular risk factors in subjects Tokushima Graduate Medicine M 2113 with the metabolic syndrome: A randomized comparable School of Health study Biosciences 266 Improved endothelial function and inflammation Imamura Bun-in Diabetes Kamada T Diabetologia 2012; 55(Suppl1): after replacement of insulin by in combination Hospital S321 with metformin and sulfonylurea in type 2 diabetic patients 267 Dipeptidyl peptidase-4 inhibitor (sitagliptin) improves Asahi General Diabetes and Metabolic Yamane T Diabetologia 2012; 55(Suppl1): insulin sensitivity and atherosclerosis-related biomarkers Hospital Disease S323 in patients with type 2 diabetes 268 Combination therapy with low dose glimepiride and Shinshu University Aging Medicine Ishii H Diabetologia 2012; 55(Suppl1): sitagliptin is effective for poorly controlled Japanese School of Medicine S343 patients with type 2 diabetes 269 Alternative markers of hyperglycemia and risk of diabetes Johns Hopkins School Medicine Juraschek SP Diabetes Care 2012; 35(11): 2265- of Medicine 2270 270 Association of alternative markers of glycemia with Johns Hopkins School Epidemiology and Juraschek SP Clinical Chemistry 2012; 58(12): hemoglobin A1c and fasting glucose of Medicine Clinical Research 1648-1655 271 Comparing multiple measures of glycemia: How to University of Medicine Cohen RM Clinical Chemistry 2012; 58(12): transition from biomarker to diagnostic test ? Cincinnati College of 1615-1617 Medicine

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 19 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 272 Relationship between nontraditional and standard Johns Hopkins Univ Juraschek SP Circulation 125, AMP039, 2012 markers of glycemia 273 Serum 1,5-anhydro-D-glucitol(1,5AG) is associated with Hyogo Prefectural Cardiovascular Medicine Emoto T Cardiovascular Intervention and endothelial dysfunction and coronary plaque Awaji Hospital Cardiovascular Medicine Therapeutics 2012; vulnerability in diabetes patients with coronary artery 4(Supplement2): 629 diseases 274 Efficacy and safety of switching from insulin glargine to Saitama Medical Endocrinology and Kurihara S Therapeutic 2012; Research 33(9): in Japanese type 1 diabetes School Diabetes 1389-1396

275 Urinary myoinositol index: A new and better marker for Toho University Diabetes, Metabolism Miyagi M Showa Univ J Med 2012; 24(1): postmeal hyperglycemia School of Medicine and Endocrinology 33-41 276 Effect of DPP-4 inhibitor on insulin withdrawal in diabetic Tama General Internal Medicine Sakurada M Clinical Study Report (2011) patients* Medical Center 2013:360-363 277 Dose-ranging study of anagliptin in Japanese patients Kawasaki Medical Diabetes, Endocrinology Kaku K Jpn Pharmacol Ther 2012; 40(11): with type 2 diabetes - A multi-center, randomized, School and Metabolism 973-984 placebo-controlled, double-blind, parallel-group study - 278 Effectiveness of the glucagon test in estimating islet Gifu University Diabetes and Iizuka K Diabetol Int 2012; 3: 103-108 function for liraglutide treatment in a lean diabetes Endocrinology patient with impaired insulin response to glucose 279 Clinical efficacy and safety of insulin glulisine in poorly Hiroshima Kyoritsu Diabetes Morishita N J. New Rem & Clin 2013; 62(2): controlled patients with diabetes* Hospital 193-199 280 A case of hypoglycemia induced by exenatide, under Kashiwado Hospital Internal Medicine Tokuyama Y J. Japan Diab. Soc. 2013; 56(2): continuous glucose monitoring in a patients with type 2 81-86 diabetes 281 A multicenter, PhaseIII Evaluation of the efficacy and Takeda Pharmacovigilance Hiroi S Diabetes Technology & safety of a new fixed-dose pioglitazone/glimepiride Pharmaceutical Therapeutics 2013; 15(2): 158-165 combination tablet in Japanese patients with type 2 Co.,Ltd. diabetes 282 An anti-inflammatory sterol decreases obesity-related Harbor Therapeutics, Reading CL Mediators of Inflammation 2013; inflammation-induced insulin resistance and metabolic Inc. Article ID 814989: 16 dysregulation 283 Relationship between postprandial glucose level and Nippon Medical Internal Medicine Watanabe K BMC Cardiovascular Disorders carotid artery stiffness in patients without diabetes or School 2013; 13: 11 cardiovascular disease 284 Comparison of the anti-atherogenic and anti-metabolic Hyogo Prefectural Sawada T American Journal of Cardiology effects between miglitol and nateglinide in diabetic Awaji Hospital 2013; 111(7): 32B patients with coronary artery disease

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 20 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 285 Effect of 3 times daily insulin aspart 70 in poorly Hirosaki University Endocrinology and Matsuhashi Y Prog. Med. 2013; 33(3): 585-588 controlled type 2 diabetes treated with twice daily insulin Metabolism mix* 286 Clinical study of a fixed-dosed mitiglinide/voglibose MVCCT Study Group Hiyoshi T Therapeutic Research 2013; 34(3): combination in patients with type 2 diabetes mellitus - of the Shibuya 379-390 Clinical assessment of glycemic markers, HbA1c, glycated Medical Association albumin and 1,5-anhydroglucitol - 287 Comparison between sitagliptin and nateglinide on Japanese Red Cross Kojima Y World J Diabetes 2013; 4(1): 8-13 postprandial lipid levels: The STANDARD study Medical Center 288 Addition of sitagliptin to ongoing metformin The University of Graduated School of Kadowaki T Journal of Diabetes Investigation monotherapy improves glycemic control in Japanese Tokyo Medicine 2013; 4(2): 174-181 patients with type 2 diabetes over 52 weeks 289 Evaluation of glycemic variability in well-controlled type 2 Kyung Hee University Endocrinology and Chon S Diabetes Technology & diabetes mellitus School of Medicine Metabolism Therapeutics 2013; 15(6): 455-460 290 Increased glycemic variability at the onset and during Biomedical Rodbard D Diabetes Technology & progression of type 2 diabetes - Commentary Informatics Therapeutics 2013; 15(6): 445-447 Consultants LLC 291 The use of 1.5-anhydroglucitol for monitoring glycemic Diabetes Research Peixoto EML Cell Transplant 2014; 23(10): control in islet transplant recipients Institute 1213-1219

292 Comparison of the effect of ultra-rapid insulin in Kanazawa Red Cross Diabetes and Kidney Hamaguchi E J. New Rem. & Clin. 2013; 62(7): intensive insulin therapy* Hospital Center 1273-1281 293 and cardiovascular disease* National Cerebral and Preventive Cardiology Watanabe M Prevention of Arteriosclerosis Cardiovascular Center 2013; 12(1): 12-17 294 Plasma 1,5-anhydroglucitol levels on admission can University of Fukui Cardiovascular Medicine Koike M Circulation Journal 2013; predict the ventricular function at 1-month after an acute School of Medical 77(Suppl.I): I-2024 myocardial infarction: A novel predictor Sciences 295 Preprocedual lower levels of serum 1,5-anhydroglucitol Tokyo Disaster Cardiology Ito J Circulation Journal 2013; are associated with restenosis after percutaneous Medical Center Cardiovascular Medicine 77(Suppl.I): I-2616 coronary intervention 296 1,5-anhydroglucitol is a stronger predictor of coronary National Center for Cardiovascular Ikeda N Circulation Journal 2013; artery disease than hemoglobin A1c Global Health and 77(Suppl.I): I-2617 Medicine 297 Efficacy and safety of sitagliptin as add-on therapy on Kumamoto University Metabolic Medicine Shimoda S Endocr J. 2013; 60(10): 1207-1214 glycemic control and blood glucose fluctuation in Japanese type 2 diabetes subjects ongoing with multiple daily insulin injections therapy

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 21 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 298 Efficacy of alogliptin, a dipeptidyl peptidase-4 inhibitor, University of Internal Medicine Sakata K Diabetes Metab Res Rev 2013; 29: on glucose parameters, the activity of the advanced Miyazaki 624-630 glycation end product-receptor for advanced glycation end product axis, and in Japanese type 2 diabetes 299 Dipeptidyl peptidase-4 inhibitors improve glycaemic Gunma University、 Clinical Laboratory Araki O 49th EASD 2013; No.884 control in latent autoimmune diabetes in adults (LADA) Schoold of Medicine patients insufficiently controlled despite insulin therapy 300 Two prandial insulin approaches for achieving adequate University of Veterans Affairs Medical Edelman S 49th EASD 2013; No.1024 glycaemic control in patients not at goal HbA1c on basal California San Diego Center insulin plus oral agents alone: the AUTONOMY study 301 Switching from intensive insulin therapy to basal Toyota Kouseiren Internal Medicine Katoh D J. New Rem. & Clin. 2013; 62(9): supported oral therapy with sitagliptin or glimepiride* Hospital 1561-1568 302 Efficacy and safety of glycemic control in type 2 diabetes Keio University Nephrology, Saisyo Y J. New Rem. & Clin. 2013; 62(9): patients when switched to mitiglinide/voglibose fixed- School of Medicine Endocrinology and 1569-1575 dose combination therapy* Metabolism 303 Comparison of the hypoglycemic effect of sitagliptin St. Marianna Metabolism and Ohta A Expert Opin. Pharmacother 2013; versus the combination of mitiglinide and voglibose in University School of Endocrinology 14(17): 2315-2322 drug-naïve Japanese patients with type 2 diabetes Medicine 304 Comparison of effects of α-glucosidase inhibitors and Himeji Brain and Cardiovascular Medicine Sawada T Circ J. 2014; 78(1): 248-255 glinide drugs on endothelial dysfunction in diabetic Heart Center patients with coronary artery disease 305 Effect of Canagliflozin, a sodium glucose co-transporter 2 Janssen Research & Balis DA J Diabetes. 2014; 6(4): 378-380 inhibitor, on measurement of serum 1,5-anhydroglucitol Development 306 Effect of mulberry leaf extract with enriched 1- Nippon Medical Endocrinology and Asai A Journal of diabetes investigation deoxynojirimycin content on postprandial glycemic School Metabolism 2011; 2(4): 318-323 control in subjects with impaired glucose metabolism 307 Ameliorating effects of miglitol on postprandial Hyogo Prefectural Terashita D European heart journal 2013; 34: hyperglycemia and /HDL ratio are associated Awaji Medical Care 414-415 with beneficial impact on atherosclerosis in diabetic Center patients with coronary artery disease 308 Relationship between preprocedual serum 1,5- Disaster Medical Cardiology Ito J European heart journal 2013; 34: anhydroglucitol concentrations and restenosis after Center Cardiovascular Medicine 786 implantation of drug-eluting stent 309 Efficacy and safety of switching from intensive insulin Toyota Kouseiren Endocrinology and Katoh D J. New Rem. & Clin 2014; 63(1): therapy to insulin glulisine* Hospital Metabolism 71-77 310 Clinical efficacy of sitagliptin in Japanese type 2 diabetes* Watanabe Clinic Watanabe G J. New Rem. & Clin 2014; 63(2): 192-199

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 22 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 311 1,5-anhydroglucitol in saliva is a noninvasive marker of Weill Cornell Medical Physiology and Mook- J Clin Endocrinol 2014; Metab short-term glycemic control College Biophysics Kanamori DO 99(3): E479-E483 312 Long-term effects of mitiglinide in Japanese diabetics Kawasaki Medical Diabetes, Endocrinology Kaku K Diabetes Ther 2014; 5(1): 97-111 inadequately controlled with DPP-4 inhibitor or School and Metabolism monotherapy 313 Thresholds of various glycemic measures for diagnosing Kyushu University Environmental Medicine Mukai N Cardiovascular Diabetology 2014; diabetes based on prevalence of retinopathy in 13:45 community-dwelling Japanese subjects: the Hisayama Study 314 Circulating CD3+56+ cell subset in pre-diabetes Poznan University Pharmacology Dworacka M Exp Clin Endocrinol Diabetes Medical Science 2014; 122(2): 65-70 315 Efficacy of adding once- and thrice-daily voglibose in Osaka University Metabolic Medicine Takahara M Endocr J. 2014; 61(5): 447-456 Japanese type 2 diabetic patients treated with alogliptin Graduate School of Medicine 316 The prognostic value of 1,5-anhydroglucitol Johns Hopkins Selvin E Circulation 2014; 129: SUPPL.1 University 317 Lower 1,5-anhydroglucitol is associated with denovo Saitama Medical Cardiovascular Medicine Fujiwara T Heart and Vessels 2015; 30(4): coronary artery disease in patients at high cardiovascular Center, Jichi Medical 469-476 risk University 318 Efficacy and safety of sitagliptin in Japanese patients with Mie Chuo Medical Internal Medicine Tanaka T J Diabetes Invest 2014; 5(2): 199- type 2 diabetes switched from glinides Center 205 319 Successful treatment with liraglutide in a diabetic Akita Red Cross Metabolism Kudo H J. Japan Diab. Soc. 2014; 57(3): patients with widely fluctuating blood glucose levels due Hospital 175-180 to the formation of insulin antibodies 320 Decreased plasma 1,5-anhydroglucitol in diabetic Akanuma Y Diabetes 1981; 30(Suppl 1): 124A patients 321 1.5-anhydro-D-glucitol: a novel marker of glucose Karol Marcinkowski Pharmacology Dworacka M International Journal of Clinical excursions University of Medical Practice 2002; Supplement 129: Sciences 40-44 322 A patients with variant hemoglobin diagnosed based on Aichi-Gakuin Internal Medicine Naruse K J. Japan Diab. Soc. 57(2): 118-123 abnormal pattern between the s-A1c and A0 peaks on University routine laboratory HbA1c measurement using HPLC 323 Effectiveness of miglitol combined with various types of Toho University Diabetes, Metabolism Hirose T Ther Res 2013; 34(12): 1503-1511 insulin therapy for reducing the daily glycemic fluctuation School of Medicine and Endocrinology on Japanese type 2 diabetic patients 324 What is the determinant for circulating endothelial University of Fukui Cardiovascular Medicine Morishita T Circulation Journal 2014; progenitor cells in patients with coronary artery disease Cardiovascular Medicine 78(Suppl.1): I-2683 and type 2 diabetes mellitus?

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 23 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 325 The relationship between postprandial blood glucose and Urasoe General Cardiovascular Medicine Uehara H Circulation Journal 2014; coronary plaque stability in stable angina patients; Hospital 78(Suppl.1): I-1775 Optical coherence tomography analysis 326 Predictive values of 1,5-anhydro-d-glucitol and National Center for Cardiovascular Medicine Ikeda N Circulation Journal 2014; hemoglobin A1c for prevalence of coronary artery Global Health and 78(Suppl.1): I-1360 disease in non-diabetic population Medicine 327 Clinical efficacy and safety of insulin glulisine* Hiroshima Kyoritsu Diabetes Morishita N J. New Rem. & Clin. 2014; 63(3): Hospital 345-350 328 Effect of combination therapy with sitagliptin in type 2 Tama General Internal Medicine Satoh F Clinical Study Report (hospital diabetes with insulin therapy* Medical Center management in Tokyo, 2012) 2014: 545-549 329 Relationship between average and variability of glucose Jichi Medical Endocrinology and Nagasaka S Research Report of Daiwa and glycemic markers in measurement of CGM* University Metabolism Securities Health Foundation 2014; 37: 18-23 330 1,5-AG as an index of glycemic variability and its Kashiwado Hospital Internal Medicine Tokuyama Y J. Japan Diab. Soc. 2014; 57(4): application to therapy evaluation 227-234 331 1,5-anhydro-D-glucitol predicts coronary artery disease National Center for Cardiovascular Medicine Ikeda N Journal of Cardiology 2014; 64(4): prevalence and complexity Global Health and 297-301 Medicine 332 Association of reduced levels of serum 1,5-anhydro-D- Itoigawa General Sato T Journal of Diabetes and Its glucitol with carotid atherosclerosis in patients with type Hospital Complications 2014; 28(3): 348- 2 diabetes 352 333 Exploratory trial of intranasal administration of Glucagon- University of Neurology,Respirology, Ueno H Diabetes Care 2014; 37(7): 2024- Like Peptide-1 in Japanese patients with type 2 diabetes Miyazaki Endocrinology and 2027 Metabolism 334 Cotreatment with the α-glucosidase inhibitor miglitol and The University of Laboratory of Nutritional Imai C Metabolism 2014; 63(6): 746-753 DPP-4 inhibitor sitagliptin improves glycemic control and Shizuoka Physiology reduces the expressions of CVD risk factors in type 2 diabetic Japanese patients 335 Statins in low doses reduce VEGF and bFGF serum levels Poznan University of Pharmacology Dworacka M Pharmacology 2014; 93: 32-38 in patients with type 2 diabetes mellitus Medical Science 336 1,5-anhydro-D-glucitol predicts prevalence of coronary National Center for Cardiovascular Medicine Ikeda N Journal of the American College of artery disease even in non-diabetic adults Global Health and Cardiology 2014; 63(Issue 12): Medicine A1331 337 Low levels of 1,5-anhydro-D-glucitol are associated with University of Internal Medicine Torimoto K Cardiovascular Diabetology 2014; vascular endothelial dysfunction in type 2 diabetes Occupation and 13: 99 Environmental Health 338 Effect of repaglinide, administered two of three times Yokohama City Endocrinology and Kamiyama H Journal of International Medical daily for 3 months, on glycaemic control in Japanese University Graduate Metabolism Research 2014; 42(5): 1150-1160 patients with type 2 diabetes mellitus School of Medicine

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 24 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 339 Effects of intake of puffed wx ae double mutant brown Osaka Prefecture Rehabilitation Horino S J Life Sci Res 2011; 9: 7-11 rice on human blood glucose and lipid levels University 340 The effects of combination therapy with miglitol and Nakakinen Clinic Osonoi K Medical Consultation & New sitagliptin in patients with type 2 diabetes who showed Remedies 2011; 48(5): 471-482 an inadequate response to monotherapy with either agent 341 Addition of sitagliptin improved glycemic control and was Tajima N Diabetes 2014; 63: A268 (74th well tolerated in Japanese patients with type 2 diabetes ADA) on glinides monotherapy 342 The relationship among alternative markers of glycemia Chan LC Diabetes 2014; 63: A314-A315 and A1C, 2-hr PG, and continuous glucose monitoring in (74th ADA) obese adolescents 343 A prospective metabonomics analysis reveals new Arredouani A Diabetes 2014; 63: A414 (74th pathways involved in T2D development ADA) 344 1,5-anhydroglucitol and methylglyoxal - new post- Institute of Forensic Hess C Rechtsmedizin 2011; 21(4): 406- mortem marker for glucose metabolism disorders? Medicine 407 345 The soluble isoform of the receptor for advanced Federal University of Anghebem- Clin Chem Lab Med 2014; glycation end products (esRAGE) as a biomarker for long- Parana Oliveria MI 52(Special Suppl.): S639 term glycemic control in type 2 diabetes 346 Effects of standard dose of vildagliptin vs sitagliptin on Hokkaido University Medine II Kimachi K Diabetologia 2014; 57(Suppl 1): blood glucose fluctuations evaluated by long-term self- S379 monitoring blood glucose (SMBG) 347 Plasma profiles are associated with insulin, C- Ajinomoto Co., Inc. Institute for innovation Nakamura H Nutr Diabetes 2014; 4: e133 (1-8) peptide and adiponectin levels in type 2 diabetic patients 348 Association of 1,5-anhydroglucitol with diabetes and Johns Hopkins Epidemiology Selvin E Clin Chem. 2014; 60(11): 1409-18 microvascular conditions Bloomberg School of Public Health 349 Moving beyond mean glycemia: 1,5-anhydroglucitol and Harvard Medical Cardiovascular Division Lawler PR Clin Chem. 2014; 60(11): 1359- microvascular complications of diabetes School 1361 350 Effect of sitagliptin on glycemic control and St. Marianna Metabolism and Asai S Endocr J 2014; 61(12): 1213-1220 function in Japanese patients given basal-supported oral University School of Endocrinology therapy for type 2 diabetes Medicine 351 Effect of sitagliptin on glycemic control in type 2 diabetes Iwamizawa Municipal Internal Medicine Yoshimura H Diabetes Frontier 2013; 24(6): treated with low dose of glimepiride* General Hospital 747-751 352 The efficacy of sitagliptin on glycemic control in type 2 Hotaruno Central Uchida D Medical Consultation & New diabetes with treatment of vildagliptin Clinic of Internal Remedies 2014; 51(5): 519-522 Medicine 353 The efficacy of combination therapy with α-glucosidase Hotaruno Central Uchida D Ther Res 2014; 35(6): 615-620 inhibitor plus DPP-4 inhibitor* Clinic of Internal Medicine

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 25 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 354 Strong correlation between glycaemic variability and Dong-A University Endocrinology and Suh S Diabetes & Metabolism 2014; total glucose exposure in type 2 diabetes is limited to Medical Center Metabolism 40(4): 272-277 subjects with satisfactory glycaemic control 355 Clinical significance of measurement of 1,5- Juntendo University Cardiovascular Medicine Sai E Circulation Journal 2014; anhydroglucitol in patients with coronary artery disease School of Medicine 78(Suppl.I): OE-154 and acute coronary syndrome 356 Efficacy of alogliptin on glucose parameters, the activity University of Sakata K The Journal of Clinical of the advanced glycation end product- receptor for Miyazaki Hypertension 2013; 15(suppl.1): advanced glycation end product axis, and albuminuria in A45 uncontrolled type 2 diabetes 357 Prescription and quality of diabetes care provided by SANYO Electric Group The Health Care Center Hidaka H J. Japan Diab. Soc. 2014; 57(10): specialists and general physicians in Japan - An analysis of Health Insurance 774-782 insurance claim and health checkup data - 358 Comparative associations of diabetes risk factor with five The Welch Center for Epidemiology Poon AK BMJ Open Diabetes Res Care. measures of hyperglycemia Prevention 2014; Apr 8;2(1) [Epub ahead of print] 359 Concomitant use of miglitol and mitiglinide as initial Kawasaki Medical Diabetes, Endocrinology Tatsumi F Diabetes Research & Clinical combination therapy in type 2 diabetes mellitus School and Metabolism Practice 2013; 101(1): 35-44

360 Randomized, double-blind, dose-ranging study of TAK- Kawasaki Medical Diabetes, Endocrinology Kaku K Diabetes Care 2013; 36(2): 245- 875, a novel GPR40 agonist, in Japanese patients with School and Metabolism 250 inadequately controlled type 2 diabetes 361 Mitiglinide/voglibose fixed-dose combination improves Yuri Ono Clinic Diabetes Ono Y Expert Opin. Pharmacother 2013; postprandial glycemic excursions in Japanese patients 14(4): 361-370 with type 2 diabetes mellitus 362 Effects of combination therapy with mitiglinide and Ashiya Municipal Internal Medicine Konya H Diabetes, Metabolic Syndrome voglibose on postprandial plasma glucose in patients with Hospital and Obesity: Target and Therapy type 2 diabetes mellitus 2013; 6: 317-325 363 Sitagliptin added to voglibose monotherapy improves Jikei University Metabolic Diseases Tajima N Journal of Diabetes Investigation glycemic control in patients with type 2 diabetes School of Medicine 2013; 4(6): 595-604 364 Efficacy and safety of sitagliptin add-on therapy in The University of Metabolic Diseases Kadowaki T Diabetol Int 2013; 4: 160-172 Japanese patients with type 2 diabetes on insulin Tokyo monotherapy 365 'Patient-centered care' for complex patients with type 2 University of Nursing and Health Hackel JM Clinical Medicine Insights: diabetes mellitus - Analysis of two cases Massachusetts Science Endocrinology and Diabetes 2013; Boston 6: 47-61 366 Effects of alogliptin in chronic patients Nippon Medical Nephrology Sakai Y Internal Medicine 2014; 53: 195- with type 2 diabetes School Musashikosugi 203 Hospital

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 26 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 367 SYR-472, a novel once-weekly dipeptidyl peptidase-4 Kyoto University Diabetes Inagaki N Lancet Diabetes Endocrinol 2014; (DPP-4) inhibitor, in type 2 diabetes mellitus: a phase 2 Graduated School of 2: 125-132 randomized, double-blind, placebo-controlled trial Medicine 368 Exenatide once weekly versus insulin glargine for type 2 VU University Diabetes Center Diamant M Lancet Diabetes Endocrinol 2014; diabetes (DURATION-3): 3-year results of an open-label Medical Center 2: 464-473 randomized trial 369 The glycemic/metabolic responses to meal tolerance Yuri Ono Clinic Diabetes Ono Y Expert Opin. Pharmacother. 2014; tests at breakfast, lunch and dinner, and effects of the 15(3): 311-324 mitiglinide/voglibose fixed-dose combination on postprandial profiles in Japanese patients with type 2 diabetes mellitus 370 Efficacy and safety of alogliptin added to insulin in Kawasaki Medical Diabetes, Endocrinology Kaku K Expert Opin. Pharmacother. 2014; Japanese patients with type 2 diabetes: a randomized, School and Metabolism 15(15): 2121-2130 double-blind, 12-week, placebo-controlled trial followed by an open-label, long-term extension phase 371 Initiation and gradual intensification of premixed insulin Second University of Geriatrics and Metabolic Giugliano D Diabetes Care 2014; 37(2): 372- lispro therapy versus basal ±mealtime insulin in patients Naples Diseases 380 with type 2 diabetes eating light breakfast 372 AUTONOMY: The first randomized trail comparing two University of Medicine Edelman SV Diabetes Care 2014; 37(8): 2132- patient-driven approaches to initiate and titrate prandial California 2140 insulin lispro in type 2 diabetes 373 Glucagon-like peptide 1 receptor agonist or bolus insulin VU University Diabetes Center Diamant M Diabetes Care 2014; 37(10): 2763- with optimized basal insulin in type 2 diabetes Medical Center 2773 374 Efficacy and safety of the dipeptidyl peptidase-4 inhibitor Chiba University Clinical Cell Biology and Kobayashi K Diabetes, Obesity and Metabolism sitagliptin compared with α-glucosidase inhibitor in Graduate School of Medicine 2014; 16(8): 761-765 Japanese patients with type 2 diabetes inadequately Medicine controlled on sulfonylurea alone (SUCCESS-2): a multicenter, randomized, open-label, non-inferiority trial 375 The effect of addition of liraglutide to high-dose intensive Mountain Diabetes Lane W Diabetes, Obesity and Metabolism insulin therapy: a randomized prospective trial and Endocrine Center 2014; 16: 827-832 376 Using miglitol at 30 min before meal is effective in Yokohama-City Endocrinology and Shirakawa J Endocrine Journal 2014; 61(11): hyperinsulinemic hypoglycemia after a total gastrectomy University Metabolism 1115-1123 377 Profile of saxagliptin in the treatment of type 2 diabetes: Ashiya Municipal Internal Medicine Konya H Therapeutics and Clinical Risk focus on Japanese patients Hospital Management 2014; 10: 547-558 378 Differences between rosuvastatin and atorvastatin in Kumamoto University Cardiovascular Medicine Ogawa H Circulation Journal 2014; 78: lipid-lowering action and effect on glucose metabolism in 2512-2515 Japanese hypercholesterolemic patients with concurrent diabetes - Lipid-lowering with highly potent statins in hyperlipidemia with type 2 diabetes patients (LISTEN) study -

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 27 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 379 Comparison of the administration of teneligliptin every Yokohama-City Endocrinology and Kamiko K Journal of Clinical Pharmacology day versus every other day in Japanese patients with type University Metabolism 2015; 55(2): 144-151 2 diabetes: A randomized non-inferior test 380 Vildagliptin vs liraglutide as a second-line therapy Kanazawa University Disease Control and Takeshita Y J Diabetes Invest 2015; 6(2): 192- switched from sitagliptin-based regimens in patients with Graduated School of Homeostasis 200 type 2 diabetes: A randomized, parallel-group study Medical Sciences 381 Association of retrospective markers of glycemia and the Jagiellonian Diagnostics Solnica B Clin Chem Lab Med 2015; 53(1): use of continuous glucose monitoring in white adults University e15-e17 with type 2 diabetes mellitus - a preliminary report 382 Salivary protein glycosylation as a noninvasive biomarker Nizam's Institute of Rao PV Journal of Diabetes Science and for assessment of glycemia Medical Sciences Technology 2015; 9(1): 97-104 383 Predictive value of 1,5-anhydroglucitol for prevalence of National Center for Caridiology Ikeda N European Heart Journal 2014; coronary artery disease in non-diabetic adults Global Health and Cardiovascular Medicine 35(Suppl1): 399 Medicine 国立国際医療研究 センター 384 A pilot three-month sitagliptin treatment increases Osaka University Metabolic Medicine Hibuse T Cardiovascular Diabetology 2014; serum adiponectin level in Japanese patients with type 2 13: 96 diabetes mellitus- a randomized controlled trial START-J study 385 Pharmacokinetics and safety of subcutaneous pasireotide Peking Union Medical Clinical Pharmacology Chen X Clinical Therapeutics 2014; 36(8): and intramuscular pasireotide long-acting release in College Hospital 1196-1210 Chinese male healthy volunteers: A phase I, single-center, open-label, randomized study 386 The rs10885122 polymorphism of the adrenoceptor Federal University of Pharmaceutical Sciences Welter M Arch Endocrinol Metab. 2015; 59: alpha 2A (ADRA2A) gene in Euro-Brazilians with type 2 Parana 29-33 diabetes mellitus 387 GlycA is novel marker of inflammation among non- The Ohio State Endocrinology, Diabetes Dungan KM Inflammation 2015; Jan 15 [Epub critically ill hospitalized patients with type 2 diabetes University and Metabolism ahead of print]

388 Glycated albumin is more closely correlated with Shanghai Jiao Tong Endocrinology and Ma X Cardiovascular Diabetology 2015; coronary artery disease than 1,5-anhydroglucitol and University Affiliated Metabolism 14: 16 A1c Sixth People's Hospital 389 1,5-anhydroglucitol as a useful marker for assessing Uijeongbu St. Mary's Endocrinology and Seok H Diabetes Metab J. 2015; 39(2): short-term glycemic excursions in type 1 diabetes Hospital Metabolism 164-170 390 Once-weekly trelagliptin versus daily alogliptin in Kyoto University Diabetes, Endocrinology Inagaki N Lancet. Diabetes & Endocrinology Japanese patients with type 2 diabetes: a randomised, Graduated School of and Nutrition 2015; 3(3): 191-197 double-blind, phase 3, non-inferiority study Medicine

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 28 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 391 Racial differences in hyperglycemia: Comparative value of Johns Hopkins Epidemiology Parrinello CM Circulation 2015; 131: AP296 traditional and nontraditional glycemic markers Bloomberg Sch of Public Health 392 Glycemic excursions and cognitive function in older Johns Hopkins Rawlings A Circulation 2015; 131: AP339 adults with diabetes University 393 Association of cerebral white matter lesions with Tottori University Neurology Yamawaki M Brain Behav. 2015; 5(3): 8 cognitive function and mood in Japanese elderly people: a population-based study 394 Two non-diabetic cases of variant hemoglobin treated Osaka General Diabetes and Shimizu S J. Japan Diab. Soc. 2015; 58(2): with oral hypoglycemic agents due to spurious HbA1c Medical center Metabolism 121-127 elevation 395 Two patients with low HbA1c levels due to subclinical Kawanishi City Internal Medicine Nakamura Y J. Japan Diab. Soc. 2015; 58(2): hemolysis Hospital 128-135 396 1,5-anhydroglucitol is associated with early-phase insulin Shanghai Jiao Tong Endocrinology and Ma X Diabetes Technol Ther. 2015; secretion in Chinese patients with newly diagnosed type University Affiliated Metabolism 17(5): 320-326 2 diabetes mellitus Sixth People's Hospital 397 Association of serum 1,5-anhydro-D-glucitol with Kurekyosai Hospital Cardiology Kunita E 79th Annual Sceintific Meeting of coronary artery atherosclerosis and epicardial adipose Cardiovascular Medicine JCS 2015; OJ-021 tissue volume assessed by computed tomography in non -diabetic patients 398 Impact of serum 1,5-anhydro-d-glucitol value on National Center for Cardiology Ikeda N 79th Annual Sceintific Meeting of prediction of major adverse cardiac and cerebrovascular Global Health and Cardiovascular Medicine JCS 2015; OJ-050 events Medicine 399 Efficacy of dipeptidyl peptidase-4 inhibitor for cardiac Nihon University Cardiology Kitano D 79th Annual Sceintific Meeting of function in diabetic patients with ischemic heart disease School of Medicine Cardiovascular Medicine JCS 2015; OJ-053

400 Serum levels of 1,5-anhydroglucitol predict in-stent Disaster Medical Cardiology Yamamoto T 79th Annual Sceintific Meeting of restenosis after drug-eluting stent implantation Center Cardiovascular Medicine JCS 2015; PE-357

401 Efficacy of dipeptidyl peptidase-4 inhibitor for cardiac Nihon University Cardiology Kitano D JACC 2015; 65(10): A1417 function in diabetic patients with ischemic heart disease School of Medicine Cardiovascular Medicine

402 Lower 1,5-anhydroglucitol is associated with adverse Jichi Medical Cardiovascular Medicine Fujiwara T Heart Vessels 2016; 31: 855-862 clinical events after percutaneous coronary intervention University 403 Efficacy of switching from premix analog insulin twice Minamiakatsuka Internal Medicine Takahashi H Diabetol Int 2015; 6: 33-38 daily injection to insulin glargine once daily injection with Clinic sitagliptin

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 29 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 404 1,5-anhydro-D-glucitol can reflect hypoglycemia in Seoul National Internal Medicine Kim MK Diabetes Research and Clinical patients with well controlled type 2 diabetes University Hospital Practice 2014; 106(SUPPL. 1): S90- S91 405 Low levels of C-peptide have clinical significance for Faustman DL Diabetes 2015; 64(SUPPL.1): A71- established type 1 diabetes A72 406 Risk prediction of major complications in persons with Parrinello CM Diabetes 2015; 64(SUPPL.1): A72 diabetes 407 Glycemic variability correlates with 1.5-anhydroglucitol Mazze RS Diabetes 2015; 64 (SUPPL.1): (1.5-AHG) but not with markers of oxidation, A246 inflammation, and endothelial function: Baseline characteristics of the CAROLINA CGM substudy 408 Insulin mid mixture lispro mix50 (LM50) showed better Su Q American Diabetes Association glycemic control than low mixture lispro mix 25 (LM25) as 2015; (75th) starter insulin in Chinese patients with type 2 diabetes mellitus (T2DM): A subgroup analysis of CLASSIFY study 409 The effect of fasting status on 23 cardiometablic Varvel SA American Diabetes Association biomarkers in 96,000 subjects 2015; (75th) 410 Short-term total variability in nontraditional biomarkers Parrinello CM Diabetes 2015; 64(SUPPL.1): of hyperglycemia in older adults A433-434 411 Point-of-Care salivary protein glycosylation test for Roberts CT Diabetes 2015; 64(SUPPL.1): A636 assessment of short-term glycemia 412 Capsule commentary on Radin, Pitfalls in hemoglobin A1c San Francisco VA Feingold KR J Gen Intern Med 2013; 29(2): 363 measurement: When results may be misleading Medical Center 413 Increased circulating RANTES in type 2 diabetes Poznan University of Pharmacology Dworacka M Eur. Cytokine Netw. 2014; 25(3): Medical Sciences 46-51 414 Add-on treatment with teneligliptin ameliorates glucose Dokkyo Medical Endocrinology and Tanaka S Diabetes Technology & fluctuations and improves glycemic control index in University Metabolism Therapeutics 2014; 16(12):840- Japanese patients with type 2 diabetes on insulin therapy 845 415 Switching from ultra-rapid insulin therapy to mitiglinide Akita Red Cross Metabolism Goto T Diabetes Frontier 2015; 26(2): in patients with Basal bolus treatment* Hospital 229-232 416 HOMA-IR values are associated with glycemic control in Foundation for Hirata T J Epidemiol 2015; 25(6): 407-414 Japanese subjects without diabetes or obesity: the KOBE Biomedical Research study and Innovation 417 Association of hemoglobin A1c and glycated albumin with Kyushu University Center for Cohort Mukai N Cardiovascular Diabetology 2015; carotid atherosclerosis in community-dwelling Japanese Studies 14: 84 subjects: the Hisayama Study 418 Low levels of C-peptide have clinical significance for Harvard Medical Immunobiology Kuhtreiber Diabet Med. 2015; 32(10): 1346- established Type 1 diabetes School Laboratory WM 1353

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 30 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 419 Discrimination of -How to use gliclazide and National Hospital Diabetes and Endocrine Ijuin T Prog. Med. 2015; 35(7): 1217- glimepiride properly ? - Organization Medicine 1224 Kagoshima Medical Center 420 Effects of liraglutide monotherapy on beta cell function Keio University Internal Medicine Tanaka K Clin Drug Investig 2015; 35(10): and pancreatic enzymes compared with metformin in School of Medicine 675-684 Japanese /obese patients with type 2 diabetes mellitus: A subpopulation analysis of the KIND-LM randomized trial 421 Sitagliptin versus mitiglinide switched from mealtime Kanazawa University Disease Control and Takeshita Y BMJ Open Diabetes Res Care. dosing of a rapid-acting insulin analog in patients with Graduated School of Homeostasis 2015; 3: e000122 type 2 diabetes: a randomized, parallel-group study Medical Sciences 422 Teneligliptin improves left ventricular diastolic function Kitasato University Cardiovascular Medicine Hashikata T Heart Vessels 2016; 31: 1303- and endothelial function in patients with diabetes School of Medicine 1310 423 Effect of postprandial hyperglycemia on coronary flow University of Fukui Cardiovascular Medicine Ikeda H Diabetes & Vascular Disease reserve in patients with impaired glucose tolerance and Research 2015; 12(6): 405-410 type 2 diabetes mellitus 424 Association of 1,5-anhydroglucitol with cardiovascular Johns Hopkins Epidemiology and the Selvin E Diabetes 2016; 65(1): 201-208 disease and mortality Bloomberg School of Welch Center for Public Health Prevention 425 Case study: type 2 diabetes treated with DPP-4 inhibitor Kyorin University Internal Medicine Sumitani Y Calm 2015; 2(2): 14-15 in combination with mitiglinide/voglibose combination Hospital tablets* 426 Is it possible to switch from intensive insulin therapy to Toyota Kousei Internal Medicine Kato D Journal of New Remedies and therapy with glargine and sitagliptin or glimepiride in Hospital Clinic 2015; 64(6): 635-643 type 2 diabetes? * 427 Impact of serum 1,5-anhydro-d-glucitol value on National Center for CardiologyCardiovascular Ikeda N European Heart Journal 2015; prediction of major adverse cardiac and cerebrovascular Global Health and Medicine 36(SUPPL.1): 18 events Medicine 428 Impact of low serum levels 1,5-anhydroglucitol on Juntendo University Cardiology Takahashi S European Heart Journal 2015; cardiovascular events in patients after first-time elective School of Medicine Cardiovascular Medicine 36(SUPPL.1): 641 percutaneous coronary intervention 429 Total short-term variability in biomarkers of Johns Hopkins Epidemiology and Welch Parrinello CM Clinical Chemistry 2015; 61(12): hyperglycemia in older adults Bloomberg School of Center for Prevention 1540-1541 Public Health 430 Model analysis of effect of canagliflozin (Invokana), a Jefferson University Pathology Fortuna D Clinical Chimica Acta 2016; 452: sodium-glucose cotransporter 2 inhibitor, to alter plasma Hospitals 138-141 1,5-anhydroglucitol

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 31 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 431 Ability of 1,5-anhydro-D-glucitol values to predict National Center for Cardiovascular Medicine Ikeda N Int Heart J 2015; 56(6): 587-591 coronary artery disease in a non-diabetic population Global Health and Medicine 432 Racial differences in glycaemic marker levels among University of Cardiology Carson AP Diabetologia 2015; 58(Suppl 1): individuals without diabetes: the coronary artery risk Alabama S178 development in young adults study 433 Glycaemic variability correlates with 1.5-AHG but not International Mazze R Diabetologia 2015; 58(Suppl 1): with markers of oxidation, inflammation and endothelial Diabetes Center S564 function: baseline results of the CAROLINAⓇ CGM substudy 434 Plasma metabolomic profiles in association with type 2 Vanderbilt Epidemiology Yu D Metabolomics 2016; 12: 3 diabetes risk and prevalence in Chinese adults Epidemiology Center 435 Racial differences in and prognostic value of biomarkers Johns Hopkins Epidemiology and the Parrinello CM Diabetes Care 2016; 39(4): 589- of hyperglycemia University Welch Center for 595 Prevention 436 Effect of daily glucose fluctuation on coronary plaque Kobe University Cardiovascular Medicine Kuroda M JACC. Cardiovascular Intervention vulnerability in patients pre-treated with lipid-lowering Graduate School of 2015; 8(6): 800-811 therapy Medicine 437 Low and exacerbated levels of 1,5-anhydroglucitol are Juntendo University Cardiology Takahashi S Circulation 2015; 132: A18444 associated with cardiovascular events in patients after School of Medicine Cardiovascular Medicine first-time elective percutaneous coronary intervention 438 1,5-anhydro-d-glucitol as a predictor of cerebral Brain Attack Center Siga Y Stroke 2016; 47: ATP208 infarction in patients with glycated hemoglobin A1c Ota Memorial based good diabetes control Hospital 439 Metabolomic biomarkers for personalised glucose University Medical Julius Centre for Health Ouden Hd Metabolomics 2016; 12:27 lowering drugs treatment in type 2 diabetes Centre Utrecht Sciences and Primary Care 440 Glucose peaks and risk of dementia among persons with Johns Hopkins Rawlings A Circulation 2016; 133(Suppl 1): diabetes: The atherosclerosis risk in communities (ARIC) University MP77 study 441 Association of 1,5-anhydroglucitol with subclinical Johns Hopkins Liang M Circulation 2016; 133(Suppl 1): cardiovascular disease University P047 442 The association of serum glycated albumin with the Kangbuk Samsung Endocrinology and Jeon WS Diabetes Res Clin Pract 2016; 116: prevalence of diabetic retinopathy in Korean patients Hospital Metabolism 46-53 with type 2 diabetes mellitus 443 Efficacy of metreleptin in patients with type 1 diabetes Vasandani C ADA 2016; 76th 444 Total fat mass and BMI exhibit varying associations with Carson AP ADA 2016; 76th glycemic markers

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 32 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 445 Translational genetic approaches for diagnosing Gardner D ADA 2016; 76th monogenic diabetes in Singapore 446 Comparison of diurnal glycemic variability on day 1 vs. Onishi T ADA 2016; 76th day 7 of treatment with the once-weekly DPP-4 inhibitor trelagliptin 447 Efficacy and safety of mitiglinide/voglibose fixed-dose Keio University Endocrinology, Tanaka M Therapeutic Research 2016; 37(3): combination tablet compared with dipeptidyl peptidase- Metabolism and 285-291 4 inhibitors: Results of a cross-over study Nephrology 448 Personalised glycaemic control in critically ill type-2 Royal Adelaide Intensive Care Unit Kar P Anaesth Intensive Care 2016; diabetic patients: An exploratory study Hospital 44(2): 307-308 449 Association of CD34/CD133/VEGFR2-positive cell University of Fukui Cardiovascular Medicine Morishita T International Journal of numbers with eicosapentaenoic acid and postprandial Cardiology 2016; 221: 1039-1042 hyperglycemia in patients with coronary artery disease 450 Association of 1,5-anhydroglucitol, a biomarker of Johns Hopkins Epidemiology and the Liang M Diabetes Care 2016; 39(10): 1752- glucose peaks, with subclinical cardiovascular disease University Welch Center for 1759 Prevention 451 Impact of serum 1,5-anhydro-d-glucitol value on National Center for Cardiovascular Medicine Ikeda N Atherosclerosis 2016; 253: 1-6 prediction of major adverse cardiac and cerebrovascular Global Health and events in non-diabetic patients without coronary artery Medicine disease 452 Do glycemic marker levels vary by race? Differiing results University of Epideomiology Carson AP BMJ Open Diabetes Research and from a cross-sectional analysis of individuals with and Alabama Care 2016; 4: 1-8 without diagnosed diabetes 453 Impact of diet on efficacy of insulin lispro 25/75 and Peking Union Medical Parenteral and Enteral Chen W J Diabetes Investig 2016 June 11 insulin lispro 50/50 as starter insulin in East Asian College Hospital Nutrition [Epub ahead of print] patients with type 2 diabetes: subgroup analysis of the CLASSIFY randomized trial 454 1,5-anhydro-D-glucitol could reflect hyperglycemia risk in Seoul National Internal Medicine Kim MK Endocrinol Metab 2016; 31: 284- patients with type 2 diabetes receiving insulin therapy University College of 291 Medicine 455 Serum bilirubin levels are positively associated with Seoul National Internal Medicine Kim LK J Diabetes Investig 2016; 7(6): glycemic variability in women with type 2 diabetes University College of 874-880 Medicine 456 Factors influencing inter-day glycemic variability in University of Internal Medicine Mori H J Diabetes Investig 2016 July diabetic outpatients on insulin therapy Occupational and [Epub ahead of print] Environmental Health 457 Clincial effect of real time pulse rate monitoring with a Kyorin University Diabetes, Endocrinology Sumitani Y Diabetol Int 2016; 7: 228-234 portable pulsimeter on physical exercise therapy for male School of Medicine and Metabolism patients with type 2 diabetes

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 33 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 458 Liberal glycemic control in critically ill patients with type 2 University of Adelaide Acute Care Medicine Kar P Critical Care Medicine 2016; diabetes: An exploratory study 44(9): 1695-1703 459 Achievement rate of glycemic control for therapy with Jikei University Diabetes, Metabolism Utsunomiya K Prog. Med. 2015; 35(3): 563-569 sitagliptin in type 2 diabetes* School of Medicine and Endocrinology 460 Effects of switching from dipeptidyl peptidase-4 Komatsu Clinic Nishiyama K Prog. Med. 2015; 35(9): 1507- inhibitors taken once daily to vildagliptin taken twice 1513 daily on glycemic control in Japanese patients with type 2 diabetes 461 Usefulness of long-acting exenatide for older diabetic Kakeyu-Misayama Tohyoh S Therapeutic Research 2015; 36(5): patients with mild cognitive impairment rehabilitation center 497-502 462 Efficacy and safety of anagliptin add to insulin therapy in Kawasaki Medical Internal Medicine I Kaku K Jpn Pharmacol Ther 2015; 43(12): Japanese patients with type 2 diabetes School 1663-1686 463 Efficacy of vildagliptin in patients with type 2 diabetes Keio University Endocrinology, Tanaka M Prog. Med. 2016; 36(2): 277-282 treated with insulin on glycemic control: Investigation Metabolism and involving switching from another oral hypoglycemic Nephrology agent 464 The pattern of glycemic variability in patients treated JCHO Kanazawa Internal Medicine Furukawa K Medical Consultation & New with faster-acting insulin* Hospital Remedies 2016; 53(2): 98-99 465 Efficacy and safety of anagliptin as an add-on to glinides Kawasaki Medical Internal Medicine I Kaku K Jpn Pharmacol Ther 2016; 44(3): in Japanese patients with type 2 diabetes School 381-390 466 Relationship of glycemic control markers- 1,5 Madras Diabetes Aravindakshan Indian Journal of Endocrinology anhydroglucitol, fructosamine, and glycated hemoglobin Research Foundation T and Metabolism 2016; 20(5):690- among Asian Indians with different degrees of glucose and Dr. Mohan's 695 intolerance Diabetes Specialities Centre 467 Low and exacerbated levels of 1,5-anhydroglucitol are Juntendo University Cardiovascular Medicine Takahashi S Cardiovascular Diabetology 2016; associated with cardiovascular events in patients after Graduate School of 15: 145 first-time elective percutaneous coronary intervention Medicine 468 Impact of glycemic control with sitagliptin on the 2-year Tokyo Medical Cardiology Tomiyama H Cardiovascular Diabetology 2016; progression of arterial stiffness: a sub-analysis of the University 15: 150 PROLOGUE study 469 Safety and efficacy of liraglutide treatment in Japanese Saiseikai Kumamoto Cardiology Kajiwara M Journal of Cardiology 2017; 69(3): type 2 diabetes patients after acute myocardial Hospital 511-517 infarction: A non-randomized interventional pilot trial 470 Repeated 3-minute stair climbing-descending exercise Toyooka Hospital Honda H J Phys. Ther. Sci. 2017; 29: 75-78 after a meal over 2 weeks increases serum 1,5- Hidaka Medical anhydroglucitol levels in people with type 2 diabetes Center 471 Efficacy and safety of vildagliptin as an add-on therapy in Juntendo University Metabolism and Saito D J Clin Med Res. 2017; 9(3): 193- inadequately controlled type 2 diabetes patients treated Graduate School of Endocrinology 199 with basal insulin Medicine

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 34 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 472 Cross-over study comparing postprandial glycemic National Center for Endocrinology and Sugiyama N Med Sci Monit Basic Res 2017; 23: increase after addition of a fixed-dose Global Health and Metabolism 36-44 mitiglinide/voglibose combination or a dipeptidyl Medicine Center peptidase-4 inhibitor to basal insulin therapy in patients Hospital with type 2 diabetes mellitus 473 Excretion rates of 1,5-anhydro-D-glucitol, uric acid and Xuhui District Central Endocrinology Ma C Scientific Reports 2017 [Epub microalbuminuria as glycemic control indexes in patients Hospital ahead of print] with type 2 diabetes 474 Serum 1,5-anhydroglucitol levels slightly increase rather Shanghai Jiao Tong Endocrinology and Su H Acta Diabetol 2017; 54(5): 463- than decrease after a glucose load in subjects with University Affiliated Metabolism 470 different glucose tolerance status Sixth People's Hospital 475 Effects of 50mg vildagliptin twice daily vs. 50mg Hokkaido University Rheumatology, Nomoto H Endocr J. 2017; 64(4): 417-424 sitagliptin once daily on blood glucose fluctuations Graduate School of Endocrinology and evaluated by long-term self-monitoring of blood glucose Medicine Nephrology 476 Serum 1,5-anhydroglucitol levels slightly increase rather Shanghai Jiao Tong Endocrinology and Su H J Diabetes Investig 2017; 8(51): 40 than decrease after a glucose load in subjects with University Affiliated Metabolism different glucose tolerance status Sixth People's Hospital 477 Glucose peaks and the risk of demantia and 20-year Johns Hopkins Epidemiology Rawlings A Diabetes Care 2017 May [Epub cognitive decline Blooming School of ahead of print] Public Health 478 The glucose-lowering efficacy of sitagliptin in obese Okayama University Center for Innovative Kodera R Internal Medicine 2017; 56: 605- Japanese patients with type 2 diabetes Hospital Clinical Medicine 613 479 Comprehensive metabolomic analysis in blood, urine, fat Aarhus University Endocrinology and Korsholm AS Int. J. Mol. Sci. 2017; 18: 554 and muscle in men with metabolic syndrome: A Internal Medicine randomized, placebo-controlled clinical trial on the effects of after four months' treatment 480 1,5-Anhydroglucitol correlates with postprandial glucose University of Heller SR Diabetes 2017; 66(Supplement 1): in subjects with type 1 diabetes irrespective of HbA1c Sheffield A260-A261 responder status 481 Effect of therapy of weekly GLP-1 analog given monthly Chubu Rosai Hospital Diabetes and Imamine R Diabetes 2017; 66(Supplement 1): for elderly type 2 diabetes patients in Japan Endocrinology A285-A286 482 Decreased visceral fat and improved insulin resistance Takeda General Diabetes Center Hige H Diabetes 2017; 66(Supplement 1): together with enhanced urinary glucose excretion may be Hospital A334-A335 involved in the serum uric acid-lowering effect of dapagliflozin 483 HOMA-IR/1,5-AG ratio is a novel parameter for predicting Ayabe City Hospital Endocrinology and Senmaru T Diabetes 2017; 66(Supplement 1): the incidence of type 2 diabetes: The AYABE study Internal Medicine A415

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 35 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 484 A single dose of dapagliflozin, an SGLT-2 inhibitor, Jagiellonian Metabolic Diseases Hohendorff J Endocrine 2017; [Published online induces higher glycosuria in GCK- and HNF1A-MODY than University Medical June] in type 2 diabetes mellitus College 485 Plasma mannose levels are associated with incident type KTH-Royal Institute of Science for Life Mardinoglu A Cell Metabolism 2017; 26(2): 281- 2 diabetes and cardiovascular disease Technology Laboratory 283 486 Information content of paired measurement of A1C and Jefferson University Molligan JD Clinical Chemistry 2016; 62(10, 1,5-anhydroglucitol relative to post-prandial glucose Hospitals Supplement): S44-S45 excursions: a model simulation study 487 A single dose of dapagliflozin, an SGLT-2 inhibitor, Jagiellonian Hohendorff J Diabetologia 2017; 60(Suppl 1): induces higher glycosuria in GCK- and HNF1A-MODY than University Medical S132 in type 2 diabetes mellitus College 488 1,5-Anhydroglucitol correlates with postprandial glucose University of Heller S Diabetologia 2017; 60(Suppl 1): in subjects with type 1 diabetes irrespective of HbA1c Sheffield S312-S313 responder status 489 Efficacy and safety of fast-acting insulin aspart are UZ Leuven Mathieu C Diabetologia 2017; 60(Suppl 1): maintained over 52 weeks: comparison with insulin S314 aspart in onset 1 490 Risk factors for severe hypoglycemia in black and white Johns Hopkins Epidemiology and the Lee AK Diabetes Care 2017; September adults with diabetes: The Atherosclerosis Risk in Bloomberg School of Welch Center for [Epub ahead on line] Communities (ARIC) Study Public Health Prevention

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 36 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

Screening

No. Title Institute Department First Author Citation 1 Diabetes mellitus and 1,5-anhydro-D-glucitol JR Tokyo General Internal Medicine Ishii S The Journal of Japan Physicians Hospital Association 1990; 4(3): 329-330 2 Comparison of 1,5-anhydroglucitol, HbA1c, fructosamine for University of Teikyo Internal Medicine Yamanouchi T Diabetes 1991; 40(1): 52-57 detection of diabetes mellitus 3 Combination assay of 1,5-anhydro-D-glucitol with fasting blood JR Tokyo General Internal Medicine Ishi S J. of Transportation Med. 1991; glucose, HbA1c and fructosamine as a screening for diabetes Hospital 45(3): 99-104 mellitus 4 Assay of 1,5-Anhydroglucitol for screening for diabetes* Tohoku Kouseinenkin Internal Medicine Goto Y Diabetes Frontier 1992; 3(4): 403- Hospital 406 5 Efficacy of hemoglobin A1c, fructosamine and 1,5- Jichi Medical University Public Health Nagai M Japanese Journal of Public Health anhydroglucitol as screening tests for diabetes in local 1993; 40(3): 205-212 communities* 6 Is serum anhydroglucitol an alternative to the oral glucose Human Diabetes and Robertson DA Diabetes Medicine 1993; 10(1): tolerance test for diabetes screening? Metabolism Research 56-60 Centre 7 Relationship between multiple diagnosis of diabetes and Nagasaki University Public Health Sueda H Nagasaki Medical Journal 1993; physical risk in island population* 68(2): 231-242 8 preliminary of screening for diabetes using 1,5- Fukuoka Kuroki Health Tomooka Y The Journal of Public Health anhydroglucitol* Center Practice 1993; 57(12): 890-892 9 A study of 1,5-anhydroglucitol as a marker in screening Kameda General Clinical Laboratory Noto K Official Journal of the Japanese diabetes mellitus Hospital Society of Human Dry Dock 1993; 8(2): 31-34 10 Improvement of the sensitivity of glucose intolerance Mitsui Memorial Central Clinical Yano M J. Japan Diab. Soc. 1995; 38(4): screening by combining 1,5-AG, hemoglobin A1c and fasting Hospital Laboratory 255-260 blood glucose 11 Significance of 1,5-Anhydroglucitol in total health check - Aichi Health Center Tsushita K Japanese Journal of Multiphasic Usefulness in the screening of diabetes mellitus and effect of Health Testing and Service 1994; renal dysfunction on it - 21(2): 118-122 12 Significance of serum 1,5-anhydroglucitol measurements for Kyoto Second Red Internal Medicine Okajima Y Official Journal of the Japanese screening of diabetes mellitus in human dry dock Cross Hospital Society of Human Dry Dock 1993; 8(1): 63-66 13 Diagnostic significance of plasma 1,5-anhydroglucitol Fukushima Medical Internal Medicine Nemoto T J. Japan Diab. Soc. 1995; 38(12): measurement in screening for diabetes mellitus College 921-929 14 Comparison of 1,5-anhydroglucitol, HbA1c, fructosamine for Keio University Preventive Miyakawa M Health Science 1996; 12(1): 44-53 screening of diabetes mellitus Medicine and Public Health 15 Efficacy of hemoglobin-A1c, fructosamine and 1,5- Tochigi Public Health Nagashima Y Journal of Preventive Medicine anhydroglucitol in screening for diabetes mellitus Service Association 1994; 294: 42-46 The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 37 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 16 Effect of age and obesity on glycated haemoglobin and 1,5- Gunma University Laboratory Tsukui S Diabetes Medicine 1995; 12: 899- anhydroglucitol in screening for type 2 diabetes mellitus School of Medicine Medicine 903 17 Improvement the accuracy of screening tests for diabetes Gunma University Laboratory Tsukui S J. Japan Diab. Soc. 1996; 39(4): mellitus with a logistic regression model School of Medicine Medicine 241-246 18 Screening of glucose intolerance with fasting blood samples Mitsui Memorial Internal Medicine Siba T Japanese Journal of Clinical Hospital Medicine 1996; 54(10): 2800- 2806 19 Decreased serum 1,5-anhydroglucitol in nondiabetic subjects Gunma University Laboratory Tsukui S Diabetes Care 1996; 19(9): 940- with a family history of NIDDM School of Medicine Medicine 944 20 Efficacy of 1,5-anhydroglucitol in screening for impaired Saiseikai Matsuyama Clinical Laboratory Yamauchi M The Ehime Journal of Medical glucose tolerance* Hospital Technology 1997; 16: 47-49 21 Screening of glucose intolerance with fasting blood samples Mitsui Memorial Internal Medicine Siba T Japanese Journal of Clinical Hospital Medicine 1997; 55(Special Edition 1997): 904-909 22 Economic evaluation of alternative indicator for screening for Keio University Preventive Sirasaya K Preventive Medicine 1999; 29: diabetes mellitus Medicine and 79-86 Public Health 23 Study on cut-off point of 1,5-anhydroglucitol Aichi Health Center Yamamoto K Japanese Journal of Multiphasic Health Testing and Service 1999; 26(3): 241-245 24 Diagnosis and tests for impaired glucose tolerance and Hiroshima Atomic Health Ito C Japanese Journal of Clinical borderline type Bomb Casualty Council Management & Medicine 2005; 63(Special Edition Promotion Center 2): 355-360 25 Plasma anhydro-D-glucitol Hiroshima Medical Maeda R Japanese Journal of Clinical Association Clinical Medicine 2005; 63(Special Edition Laboratory Center 2): 386-389 26 Diagnosis and tests for diabetes mellitus Hokkaido University Internal Medicine Niwa H KLINIKA 2004; 31(6): 384-389 School of Medicine 27 Screening method for postprandial hyperglycemia using 1,5- Foundation of Kinki Shiga Department Kanazawa Y J. Japan Diab. Soc. 2006; 49(5): anhydroglucitol combined with fasting plasma glucose Health Administration Clinic 319-323 Center 28 Effective screening method and follow-up for diabetes Hiroshima Atomic Health Ito C Diabetes Up date 2006; 22: 20-29 mellitus* Bomb Casualty Council Management & Promotion Center 29 6. Health checkup･Screening for glucose intolerance in ningen Jikei University School Wada T Prog. Med. 2006; 26(9): 2097- dock checkup* of Medicine 2100 30 Study using random allocation on the long-term effectiveness Iwate Medical Hygiene and Itai K Health management association of short-term health education programs for prevention of University Preventive research grant bulletin 2007; 23: diabetes in middle-aged and elderly subjects Medicine 9-14

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 38 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 31 Screening method for postprandial hyperglycemia using 1,5- Foundation of Kinki Shiga Department Kanazawa Y Official Journal of Japan Society anhydroglucitol in order to discover subjects with postprandial Health Administration Clinic of Ningen Dock 2008; 23(3): 570- hyperglycemia in Ningen Dock Center 574 32 Screening for type 2 diabetes in obese youth Univ. Texas Pediatrics Shah S Pediatrics 2009; 124: 573-579 Southwestern Medical Center 33 Efficacy of 1,5-anhydroglucitol in screening for diabetes Asahi General Hospital Central Clinical Hiiro J The Medical Journal of Asahi mellitus* Laboratory General Hospital 2009; 31: 10-13 34 Question: Efficacy of markers for screening for prediabetes* Yokkaichi Social Clinical Laboratory Kato M Obesity & diabetes 2011; 10(4): Insurance Hospital 541-544 35 Are current diagnostic guidelines delaying early detection of NYU School of Bergman M Endocrine 2013; 44(1): 66-69 dysglycemic states? Time for new approaches Medicine 36 Relationship between serum 1,5-AG levels and macrovascular Keio University Preventive Okamura T Study Report 2013: 53-60 disease (coronary heart diseases, ) in Suita study* Medicine and Public Health 37 Usefulness of postmortem 1,5-anhydroglucitol analysis in Ehime Prefectural Medical Takaya T Japanese Journal of Medical forensic diagnosis University of Health Technology Technology 2014; 63(6): 680-686 Sciences 38 Diabetes screening in the workplace by a single casual blood Hokkaido Chuo Rosai Kaji H J. Nor. Occ. Health 2013; 49: 23- sampling using HbA1c, fructosamine and 1,5-AG: An Hospital 28 application of stepwise regression analysis 39 Measurement of postmortem 1,5-anhydroglucitol in vitreous Ehime Prefectural Medical Takata T J Forensic Sci. 2016; 61(Suppl 1): humor for forensic diagnosis University of Health Technology S150-S153 Sciences 40 Rational diagnosis of diabetes: the comparison 1,5- Ufuk University Internal Medicine Malkan UY SpringerPlus 2015; 4: 587 anhydroglucitol with other glycemic markers 41 Obesity-related metabolite profiles of black women spanning Loyola University Public Health Dugas LR Metabolomics 2016; 12: 45 the epidemiologic transition Chicago Sciences 42 Serum 1,5-anhydroglucitol level as a screening tool for Zhongda Hospital Endocrinology Wang Y Acta Diabetol 2016 November [E- diabetes mellitus in a community-based population at high risk Southeast University pub ahead of print] of diabetes 43 The establishment of biological reference intervals of The Second Affiliated Clinical Laboratory Zhou Q J Clin Lab Anal 2016; 1-7 nontraditional glycemic markers in a Chinese population Hospital of Anhui Medial University 44 Serum 1,5-anhydroglucitol when used with fasting plasma Shanghai Jiao Tong Endocrinology and Ying L Sci Rep. 2017 ; 7(1): 11968 glucose improves the efficiency of diabetes screening in a University Affiliated Metabolism Chinese population Sixth People's Hospital

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 39 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

Pediatrics

No. Title Institute Department First Author Citation 1 1-Deoxyglucose (1,5-Anhydroglucitol); A novel metabolic National Defense Pediatrics Yoshioka S Pediatrics of Japan 1983; 24(4): parameter of diabetes* Medical College 405-410 2 1-Deoxyglucose (1,5-Anhydroglucitol), Sorbitol (Glucitol) National Defense Pediatrics Fujitsuka S Japanese Journal of Pediatric Medical College Medicine 1990; 22(2): 211-216 3 Usefulness of determination of serum 1,5-anhydroglucitol in Niigata University Pediatrics Asami T The Journal of Child Health 1991; screening for diabetes mellitus in children 50(3): 389-391 4 Clinical significance of 1,5-anhydroglucitol in children with Nihon University Pediatrics Urakami T The Journal of Pediatric Practice diabetes mellitus* Hospital 1992; 55(3): 448-451 5 Clinical significance of SMBG and 1,5-anhydroglucitol for Nihon University Pediatrics Urakami T Self measurement of blood glycemic control in children with insulin-dependent diabetes Hospital glucose and management of mellitus* diabetes 1992; 10th Symposium: 59-63 6 Screening and diagnosis for diabetes mellitus in children* Osaka Rosai Hospital Pediatrics Konishi K The Journal of Pediatric Practice 1993; 56(8): 1522-1527 7 Education of glycemic control* Nihon Medical Pediatrics Ooki Y The Journal of Pediatric Practice University 1993; 8(77): 1551-1557 8 Study on serum concentration and urinary excretion of 1,5- National Defense Pediatrics Fujitsuka S J Jpn Pediatr Soc 1993; 97(6): anhydro-D-glucitol in children with insulin-dependent diabetes Medical College 1360-1372 mellitus 9 Evaluation of serum 1,5-Anhydro-D-glucitol in children with Osaka Medical College Pediatrics Tokuda M Clinical Endocrinology 1992; diabetes mellitus 40(9): 869-873 10 Reliability of 1,5-Anhydro-D-glucitol as a Marker for Detection of Nihon University Pediatrics Urakami T Clin Pediatr Endocrinol 1995; 4(1): Diabetes and an Indicator of Glycemic Control in Insulin- 25-31 dependent Diabetes Mellitus Children 11 Study on polyol metabolism in children with insulin dependent Hiroshima University Pediatrics Jinno K Hiroshima M.J. 1998; 46(3,4): 99- diabetes mellitus* School of Medicine 106 12 Urinary glucose screening for diabetes mellitus in Kumamoto Kumamoto University Pediatrics Kiwaki K J Jpn Pediatr Soc 2001; 105(2): city - Results and problems over the past 24 years - School of Medicine 94-99 13 The associaiton between Juvenile obesity and 1,5- Jikei University School Diabetes, Miyashita Y Diabetes 2007; 50(supple1): S237 Anhydroglucitol(1,5AG) of Medicine Metabolism and Endocrinology 14 Serum 1,5-anhydroglucitol (Glycomark TM) levels in children Clinical Care Center Pediatric Nguyen TM Pediatr. Diabetes 2007; 8(4): 214- with and without type1 diabetes mellitus 219 15 Education of diabetes for 7 years-old-girl with type 1 diabetes* National Center for pharmacology Kanazawa N The Pharmaceuticals 2011; 53(6): Global Health and 869 Medicine

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 40 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 16 Evaluation of 1,5-anhydroglucitol, hemoglobin A1c, and glucose Joslin Diabetes Center Pediatric Mehta SN Pediatric Diabetes 2011; 13: 278- levels in youth and young adults with type 1 diabetes and 284 healthy controls 17 Metabolomic profiles predicting type 1 diabetes Wittmann B Diabetes 2012; 61(SUPPL1): A367 18 The interrelationships of glycemic control measures: HbA1c, Jaeb center for health Laboratory Beck R Pediatric Diabetes 2011; 12: 690- glycated albumin, fructosamine, 1,5-anhydroglucitol, and research Medicine 695 continuous glucose monitoring 19 Glycemic control indicators in patients with Asahikawa Medical Pediatrics Suzuki S World J Diabetes 2014; 5(2): 198- mellitus University 208 20 Screening for type 2 diabetes and prediabetes in obese youth: Children's Hospital Pediatrics Chan CL Pediatric Diabetes 2016; 17: 206- evaluating alternate markers of glycemia - 1,5-anhydroglucitol, Colorado 211 fructosamine, and glycated albumin 21 and indicators of adiposity are adversely NICHD Lipsky LM Circulation 2015; 131: AP135 associated with cardiovascular biomarkers in youth with type 1 diabetes over 18 months 22 1,5-anhydroglucitol, a discriminatory gas chromatography-mass Lady Cilento Children's Endocrinology Conwell LS Pediatric Diabetes 2015; spectrometry(GC-MS) metabolomic marker in adolescents with Hospital 16(Suppl. 21): 41-42 type 1 diabetes- quantified using the plasma Glycomark assay 23 Value of serum 1,5-anhydroglucitol measurements in childhood Konkuk University Pediatrics Yoo HY Ann Pediatr Endocrinol Metab obesity in the continuum of diabetes Medical Center 2015; 20: 192-197 24 Greater diet quality is associated with more optimal glycemic Ennice Kennedy Health Behavior Nansel TR Am J Clin Nutr 2016; 104(1): 81- control in a longitudinal study of youth with type 1 diabetes Shriver national Branch 87 Institute of Child Health and Human Development 25 Alternate glycemic markers reflect glycemic variability in Children's Hospital Pediatric Chan CL Pediatr Diabetes 2016; : 1-8 continuous glucose monitoring in youth with prediabetes and Colorado and Endocrinology type 2 diabetes University of Colorado Anschutz Medical Campus 26 Physical activity (PA) in youth with type 1 diabetes (T1D): Joslin Diabetes Center Pediatric, Giani E Pediatric Diabetes 2016; variable impact on metabolic outcomes Adolescent and 17(Suppl. 24): 148 Young adult section 27 Glycemic control and variability in association with body mass Eunice Kennedy Health Behavior Lipsky LM Diabetes Res Clin Pract 2016; 120: index and body composition over 18 months in youth with type Shriver national Branch 97-103 1 diabetes Institute of Child Health and Human Development

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 41 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

Pregnancy

No. Title Institute Department First Author Citation 1 1-Deoxyglucose (1,5-anhydro-D-glucitol) concentration Kurume University Nakayama Y ACTA OBST GYNAEC JPN 1987; during and puerperium School of Medicine Gynecology 39(9): 1657-1658 2 Serum levels of 1,5-anhydro-D-glucitol during the normal Kurume University Obstetrics Tetsuo M Acta Obset Gynecol Scand 1990; 69: and diabetic pregnancy and puerperium School of Medicine Gynecology 479-485 3 Efficacy of 1,5-Anhydro-D-glucitol in screening for Kurume University Obstetrics Yoshimatsu K Practice 1991: 18-26 mellitus* School of Medicine Gynecology 4 Clinical significance of 1,5-anhydroglucitol in pregnant Asahikawa Medical Obstetrics Sasaki K The World of Obstetrics and women with normal and abnormal glucose tolerance* University Gynecology Gynecology 1992; 44(2): 17-22

5 Serum 1,5-anhydroglucitol (1,5-AG) in pregnant diabetic Tokyo Women's Diabetes Center Sanaka M J. Japan Diab. Soc. 1993; 36(2): 93- Medical College 100 6 Fetal and maternal 1,5-anhydroglucitol (1,5-AG) in pregnant Tokyo Women's Internal Medicine Morita Y J Tokyo Wom Med Univ 1993; rats Part II: Distribution of 1,5-AG in normal pregnant rats Medical College 63(2): 64-69 7 Serum 1,5-anhydroglucitol (1,5-AG) in pregnant diabetics at Tokyo Women's Diabetes Center Sanaka M J. Japan Diab. Soc. 1993; 36(2): 93- delivery and in cord serum Medical College 100 8 Fetal and maternal 1,5-anhydroglucitol (1,5-AG) in pregnant Tokyo Women's Internal Medicine Morita Y J Tokyo Wom Med Univ 1993; rats Part I: Alteration of serum 1,5-AG in normal pregnant Medical College 63(2): 191-195 rats 9 Efficacy of 1,5-anhydroglucitol (AG) in management for Hirosaki University Obstetrics Tanaka M Practice 1991: 41-47 gestational diabetes mellitus* School of Medicine Gynecology

10 Disorders of carbohydrate metabolism Mie University School Obstetrics Toyoda N Journal of Clinical Laboratory of Medicine Gynecology Medicine 1997; 41(7): 783-787 11 Application of GC/MS analysis of urinary sugar and sugar- Tetsuo Hospital Tetsuo M Proceedings of the Japanese Society alcohols to the clinical management of pregnant woman for Biomedical Mass Spectrometry with abnormal carbohydrate metabolism 1998; 23: 89-93 12 The predictive value of serum 1,5-anhydro-D-glucitol in The Chinese Univ of Obstetrics and Wing-Hung Br J Obstet Gynaecol 2001; 108: at increased risk of gestational diabetes HongKong Gynaecology Tam 754-756 mellitus and gestational impaired glucose tolerance 13 Plasma anhydro-D-glucitol(1,5-AG) as an indicator of Poznan University of Pharmacology M. Dworacka Diabetic Medicine 2005; 23: 171- hyperglycaemic excursions in pregnant women with medical 175 diabetes 14 Evaluation of 1,5-anhydroglucitol as marker of glycemic Nowak N Diabetes 2012; 61(SUPPL1): A51 control and in pregnancy complicated by type 1 diabetes mellitus 15 Metabolomics reveals broad-scale metabolic perturbations Scholtens DM Diabetes 2012; 61(SUPPL1): A340 in hyperglycemia mothers during pregnancy

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 42 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 16 1,5-anhydroglucitol (1,5-AG) is strongly associated with University of Medicine/Metabolism Wright L A-C Endocr Rev 2012; neonatal birth weight across all trimesters in pregnancy Washington 33(03_MeetingAbstract) complicated by diabetes 17 Interpretation of plasma 1,5-anhydroglucitol in pregnancy Diagnostic Service of Burton TR Clinical Biochemistry 2012; using a novel approach to establishing reference change Manitoba 45(Issues13-14): 1103 values 18 Evaluation of 1,5-anhydroglucitol as marker of glycaemic Jagiellonian Metabolic Diseases Nowak N Diabetologia 2012; 55(Suppl1): control and birth weight in pregnancy complicated by type University S437 1 diabetes mellitus 19 1,5-anhydroglucitol as a marker of maternal glycaemic Jagiellonian Metabolic Diseases Nowak N Diabetologia 2013; 56: 709-713 control and predictor of neonatal birthweight in University pregnancies complicated by type 1 diabetes mellitus 20 1,5-anhydroglucitol(1,5AG) and neonatal complications in Univ. of Washington Endocrinology Wright LA 49th EASD 2013; No.1293 pregnancy complicated by diabetes 21 Metabolomics reveals broad-scale metabolic perturbations Northwestern Feinberg school of Scholtens DM Diabetes Care 2014; 37(1): 158-166 in hyperglycemic mothers during pregnancy University Medicine 22 1,5 Anhydroglucitol serum concentration as a biomarker for Federal University of Clinical Analysis Boritza KC Clin Chem Lab Med 2014; 52(8): screening gestational diabetes in early pregnancy Parana e179-e181 23 1,5-anhydroglucitol as a marker of maternal glycaemic Jagiellonian Metabolic Diseases Nowak N Diabetes Technology & control and predictor of neonatal birthweight in University Therapeutics 2014; 16(SUPPL.1): pregnancies complicated by type 1 diabetes mellitus S72 24 1,5 Anhydroglucitol and neonatal complications in University of Wright LA Endocr Pract. 2015; 21(7): 725-733 pregnancy complicated by diabetes Washington Medical Center 25 1,5-Anhydroglucitol: a new predictor of neonatal birth University of Obstetrics & Delaney SS Eur J Obstet Gynecol Reprod Biol. weight in diabetic pregnancies Washington Genecology 2015; 189: 55-58 26 The early bird catches the worm - predicting the onset of Rotunda Hospital Obstetrics & Corcoran S J Matern Fetal Neonatal Med 2015; gestational diabetes in the first trimester Genecology 28(7): 823-824 27 Epidemiology of in pregnant Oklahoma University of Endocrinology Azar M J Clin Endocrinol Metab 2015; American Indian women Oklahoma Health 100(8): 2996-3003 Sciences Center 28 Indicators of glycemic control in patients with gestational NTT West Osaka Internal Medicine Hashimoto K World J Diabetes 2015; 6(8): 1045- diabetes mellitus and pregnant women with diabetes Hospital 1056 mellitus 29 Correlation between GlycoMark values as an index of Emek Medical Center Ob & Gyn Nachum Z Am J Obstet Gynecol 2016; glucose levels in pregnant diabetic women and the rate of 214(Suppl 1): S353-S354 clinical diabetic complications in

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 43 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 30 Low levels of serum 1,5-anhydroglucitol during pregnancy Kitasato University Health Care Center Moriya T Annals of Clinical & laboratory compared to blood glucose measured by continuous Science 2016; 46(2): 227-228 glucose monitoring 31 Metabolomic profiling of second trimester amniotic fluid Alexander J ADA 2016; 76th from mothers with diabetes during pregnancy shows evidence of altered fetal metabolism 32 The association of glycemic markers with plasma Istanbul University Endocrinology and Oztop N J Diabetes Metab 2016; 7(9) adipocytokine levels in women with gestational diabetes Metabolism 33 The relationship between proinflammatory and Istanbul University Dinccag N Diabetes 2017; 66(Supplement 1): glycemic markers in gestational diabetes A389 34 Maternal and neonatal outcomes and 1,5-anhydroglucitol in University of Walker CL ADA 2017; 77th pregnancies complicated by diabetes Washington School of Medicine 35 A computational model of 1,5-AG dynamics during Broad Institute of MIT Zekavat SM Physiological Reports 2017; 5(16): pregnancy and Harvard e13375

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 44 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

Renal Function

No. Title Institute Department First Author Citation 1 The influence of renal failure on diabetic marker, 1,5-anhydro- Gunma University Internal Medicine Kohama T Japanese Journal of Medicine and D-glucitol, I. - the relation between 1,5-anhydroglucitol and School of Medicine Pharmaceutical Science 1991; in serum levels - 25(3); 697-701 2 The influence of renal failure on diabetic marker, 1,5-anhydro- Gunma University Internal Medicine Shimizu M Japanese Journal of Medicine and D-glucitol, II. - the relation between 1,5-anhydroglucitol and School of Medicine Pharmaceutical Science 1991; urinary albumin - 25(3): 703-706 3 Low serum 1,5-anhydroglucitol concentrations in patients with Kanto Teishin Hospital Endocrinology and Harada H J. Japan Diab. Soc. 1991; 34(2): chronic renal failure Metabolism 163-166 4 Plasma 1,5-anhydroglucitol concentration in patients with End- Osaka City University Internal Medicine Emoto M 1992; 61: 181-186 stage renal disease with and without Diabetes mellitus Medical School 5 Fractional excretion of 1,5-anhydroglucitol Ehime University Internal Medicine Murakami T J. Japan Diab. Soc. 1993; 31(1): School of Medicine 59-61 6 Effect of enal function on serum 1,5-anhydroglucitol Toranomon Hospital Renal Center Yokoyama K Kidney and Dialysis 1993; 25(3): 415-417 7 Urinary excretion of 1,5-anhydroglucitol (1,5-AG) in patients Juntendo University Nephrology Takeuchi K Kidney and Dialysis 1993; 35(6): with diabetic School of Medicine 993-997 8 Quantification of 1,5-anhydroglucitol in uremic serum by Nagoya University Clinical Laboratory Niwa T Proceedings of the Japanese LC/MS Branch Hospital Society for Biomedical Mass Spectrometry 1993; 18: 185-188 9 Serum 1,5-anhydroglucitol concentrations in non-diabetic Gifu City Hospital Internal Medicine Noguchi T Annual of Gifu City Hospital 1993; patients with chronic renal failure 13: 1-6 10 Guanidinoacetic acid in serum, urine and from Juntendo University Nephrology Kiyatake I Clinical and Experimental streptozotocin-induced diabetic rats School of Medicine Nephrology 1994; 36(6): 709-714 11 1,5-Anhydroglucitol as a Marker for the Kanbara Municipal Internal Medicine Yamada H Nephron 1996; 73: 707-709 of Acute and Chronic Renal Failure Hospital 12 Plasma 1,5-anhydro-D-glucitol concentration and its relation The Queen Elizabeth Endocrine & Phillipov G Clin. Chim. Acta 1996; 247: 51-58 to other plasma components in renal failure and renal Hospital Diabetes transplant recipients 13 Renal Tubular Function Affects Glycosuria-Related Urinary Osaka City University Geriatric Medicine Fujisawa T Diabetes Care 1999; 22(5): 863- Excretion of 1,5-Anhydroglucitol Medical School 864 14 Serum concentration and renal handling of 1,5-anhydro-D- Kansai Medical Internal Medicine Shimizu H Ann Clin Biochem 1999; 36: 749- glucitol in patients with chronic renal failure University 754 15 Markers of glucose tolerance - management of diabetes* Tokyo Women's Diabetes Center Inoue A The Japanese Journal of Clinical Medical College Dialysis 2005; 21(7): 844-851 16 Glycemic control of diabetes patients or dialysis Okayama University Medicine and Fukuoka K Kidney and Dialysis 2007; 63(5): Graduate School of Clinical Science 649-654 Medicine

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 45 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 17 Hyperglycemia and diabetic renal change in a model of Kyoto University Organ Sakata N Pancreas 2007; 22(5): 602-603 polyvinyl alcohol bioartificial pancreas transplantation Reconstruction and Biomaterials 18 Glucose metabolism in diabetic patients with chronic renal Saitama Medical Endocrinology and Yamaguchi M Clinical Endocrinology 2008; failure University Diabetes 56(4): 411-417 19 Question: Relationship between postprandial hyperglycemia Nippon Medical School Internal Medicine Ouchi M Obesity & diabetes 2008; 7(6): and renal tubular function* 821-823 20 Close relationship between serum concentrations of 1,5- Kinki General Hospital Internal Medicine Koga M Clin Chim Acta. 2009; 410: 70-73 anhydroglucitol and uric acid in non-diabetic male subjects implies common renal transport system 21 Renal failure* Japanese Red Cross Chouno M Clinical nursing practice 2010; Kumamoto Hospital 31(1): 90-100 22 Serum 1,5-anhydroglucitol concentrations are a reliable index Kangbuk Samsung Internal Medicine Kim WJ Diabetes Care 2012; 35: 281-286 of glycemic control in type 2 diabetes with mild or moderate Hospital renal dysfunction 23 Use of complementary markers in assessing glycaemic control University of Hull Diabetes Konya J Diabetic Medicine 2012; in patients with diabetes and 29(Supp.1): 5-6 undergoing iron or erythropoiesis stimulating agents 24 Use of complementary markers in assessing glycaemic control University of Hull Diabetes and Konya J Diabet Med. 2013; 30(10): 1250– in people with diabetic kidney disease undergoing iron or Endocrinology 1254 erythropoietin treatment 25 Serum uric acid in relation to serum 1,5-anhydroglucitol levels Nippon Medical School Internal Medicine Ouchi M Clinical Biochemistry 2013; in patients with and without type 2 diabetes mellitus 46(15): 1436-1441 26 Change in urinary N-acetyl-β-D-glucosaminidase levels Nippon Medical School Internal Medicine Ouchi M Clin Chim Acta 2014; 433: 88-92 relevant to postprandial glycemic control conditions in subjects without diabetes mellitus 27 Postprandial glycemic control conditions in relation to urinary Nippon Medical School Internal Medicine Ouchi M Diabetes technology & N-acetyl-β-D-glucosaminidase in patients with type 2 diabetes therapeutics 2014; 16(1): 41-47 mellitus without low glomerular filtration rate 28 Are there better alternatives than haemoglobin A1c to Ghent University Renal division Speeckaert M Nephrol Dial Transplant 2014; 0: estimate glycaemic control in the chronic kidney disease Hospital 1-11 population? 29 Relationship between serum 1,5-anhydroglucitol, as an Nippon Medical School Internal Medicine Ouchi M J Nippon Med Sch 2014; 81(3): indicator of postprandial glycemic control and serum uric acid, 188-189 considering the renal threshold for glucosuria in the elderly 30 Serum metabolomic profiling and incident CKD among African University of Texas Epidemiology Yu B Clinical Journal of the American Americans Health Science Center Society of Nephrology 2014; 9(8): at Houston 1410-1417 31 Glycemic management in ESRD and earlier stages of CKD Joslin Diabetes Center Renal division Williams ME Am J Kidney Dis. 2014; 63(2): S22- S38

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 46 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 32 Association between pulse wave velocity and a marker of renal Dokkyo Medical Pharmacology and Ouchi M J Clin Hypertens 2015; 17(4): 290- tubular damage(N-acetyl-β-D-glucosaminidase) in patients University School of Toxicology 297 without diabetes Medicine 33 Metabolite markers of incident CKD risk Massachusetts General Nephrology Rhee EP Clin J Am Soc Nephrol 2014; 9(8): Hospital 1344-1346 34 Effect of renal function on serum concentration of 1,5- Diabetesinstitut Clinical Studies Hasslacher C J of Diabetes 2016; 8: 712-719 anhydroglucitol in type 2 diabetic patients in CKD stages I-III: a Heidelberg comparative study with HbA1c and glycated albumin 35 Metabolomics reveals differential changes in the energy Wang Y Journal of Urology 2016; 195(4S generating pathways of the detrusor and urothellium caused supplement): e414 by diabetes 36 Interactions between kidney disease and diabetes: dangerous School of Medicine, Pecoits-Fiho R Diabetol Metab Syndr 2016; 8: 50 liaisons Pontificia University Católica do Paraná 37 Serum levels of 1,5-anhydroglucitol and risk of incident end- Johns Hopkins Epidemiology Rebholz CM Am J Epidemiol. 2017; 186(8): stage renal disease Bloomberg School of 952-960 Public Health

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 47 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

Other Diseases

No. Title Institute Department First Author Citation 1 Clinical significance of serum 1,5-Anhydroglucitol (AG) Osaka Prefectural Gastroenterology Kanda T Medical Journal of Osaka concentration in patients with liver cirrhosis Hospital and Metabolism Prefectural General Hospital 1990; 13(1):15-18 2 A clinical study of 1,5-anhydro-D-glucitol in sera of malignant Saitama Cancer Clinical Laboratories Ishii M Japanese Journal of Medicine and tumor patients Center Pharmaceutical Science 1991; 25(3): 691-696 3 Serum 1,5-Anhydroglucitol concentrations in patients with liver Kanazawa University First Department of Yamagishi S J. Japan Diab. Soc. 1992; 35(5): cirrhosis Internal Medicine 381-384 4 Clinical significance of serum 1,5-Anhydroglucitol level in liver Osaka Prefectural Gastroenterology Kanda T J. Japan Diab. Soc. 1992; 35(11): cirrhosis Hospital and Metabolism 899-907 5 Clinical significance of HbA1c serum fructosamine and 1,5-AG in Osaka Prefectural Gastroenterology Kanda T J. Japan Diab. Soc. 1993; 36(11): diabetic patients complicated with liver cirrhosis Hospital and Metabolism 847-854 6 Clinical studies of long-term glycemic control markers in Fukui-ken Saiseikai Internal Medicine Bando Y J. Japan Diab. Soc. 1997; 40(1): patients with chronic liver disease Hospital 17-24 7 Clinical evaluation of serum 1,5AG levels in patients with liver Kanazawa University Clinical Laboratories Shibayama M Rinsho Byori 1997; 45(12): 1187- cirrhosis Hospital 1190 8 Treatment of diabetes mellitus complicated with liver cirrhosis Osaka Prefectural Gastroenterology Kanda T Clinic All-Round 1998; 47(6): Hospital and Metabolism 1910-1917 9 Polyol Profiles in Down Syndrome National Institute on Laboratory of Shetty HU J Clin Invest 1995; 95(2): 542-546 Aging Neurosciences 10 Serum 1,5-anhydro-D-glucitol levels in liver cirrhosis Kanazawa University Biochemistry Yamagishi S Acta Diabetol 1998; 35: 65-66 School of Medicine 11 Treatment of diabetes mellitus complicated with liver cirrhosis* Osaka Prefectural Gastroenterology Kanda T medicina 2000; 37(13): 2002- Hospital and Metabolism 2004 12 Glycemic control marker in diabetes with liver cirrhosis Kawasaki Medical Internal Medicine Oomoto K Medical Practice 2000; 17(10): School 1755 13 1,5-anhydroglucitol assay does not correlate with oral glucose Walter Reed Army Endocrinology Kinnaird KEH Endocr Pract. 2009 Oct 15, 1- tolerance test in cystic fibrosis patients Medical Center 10[Epub ahead of print] 14 Effects of thyroid hormone on A1C and glycated albumin levels The Catholic Internal Medicine Kim MK Diabetes Care 2010; 33(12): in nondiabetic subjects with overt hypothyroidism University of Korea 2546-2548 15 1,5-Anhydroglucitol levels are low irrespective of plasma Kinki Central Hospital Internal Medicine Koga M Annals of Clinical Biochemistry glucose levels in patients with chronic liver disease 2011; 48: 121-125 16 Lack of correlation between 1,5-anhydroglucitol assay and oral Walter Reed Army Endocrinology Kinnaird KEH Endocrine practice 2010; 16(2): glucose tolerance test in patients with cystic fibrosis Medical Center 167-170 17 Method-dependent HbA1c values in a family with hemoglobin Kuma Hospital Nishihara E Clinica Chimica Acta 2011; 412: Himeji 1689-1692

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 48 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 18 Glycemic variability is an independent prognostic factor for Kochi Medical School Gastroenterology Ono M Journal of Hepatology 58 development of hepatic fibrosis in nonalcoholic fatty liver and Hepatology (suppl.1), S545, 2013 disease 19 Metabolomics profile of response to supplementation with β- National Cancer Nutritional Mondul AM Am J Clin Nutr 2013; 98: 488-493 carotene in the alpha-tocopherol, beta-carotene cancer Institute Epidemiology prevention study Branch 20 Metabolomics in epidemiology: Sources of variability in National Cancer Cancer Sampson JN Cancer Epidemiol Biomarkers metabolite measurements and implications Institute Epidemiology and Prev. 2013; 22(4): 631-640 Genetics 21 Glycemic variability is an independent predictive factor for Kochi Medical School Gastroenterology Ochi T Hepatology 2013; 58(4) suppl: development of hepatic fibrosis in nonalcoholic fatty liver Hospital and Hepatology 505A disease 22 Glycemic variability is an independent predictive factor for Kochi Medical School Gastroenterology Hashiba M PLOS ONE 2013; 8(11): 1-9 development of hepatic fibrosis in nonalcoholic fatty liver and Hepatology disease 23 Metabolome analysis for diagnostic approach to Kobe University Gastroenterology Suzuki M The Cell 2014; 46(3): 107-110 gastroenterological cancer Graduate School of Medicine 24 Metabolome alteration in critical illness according to Brigham and Renal Division Christopher K Crit Care Med 2014; 42(12 status: A prospective cohort study Woman's Hospital Suppl.): A1443 25 Biomarker discovery for the pancreatic cancer by the serum Kobe University Gastroenterology Kobayashi T SHIMAZU Review 2014; 70(3,4): metabolomics based on gas chromatography mass 117-121 spectrometry 26 Hyperglycemia in patients with hematologic malignancies The Ohio State Endocrinology Healy SJ Curr Diab Rep 2015; 15: 8 University Wexner Medical Center 27 Searching biomarkers by metabolome analysis* Kobe University Metabolomics Yoshida M Sysmex Scientific Seminar 2014; Graduate School of Research 37th: 39-45 Medicine 28 Gastroenterological cancer diagnosis by metabolomics- Kobe University Metabolomics Yoshida M Rinsyo Byori 2015; 63(4): 450-456 discovery of pancreatic cancer biomarker Graduate School of Research Medicine 29 Plasma metabolite biomarkers for the detection of pancreatic Shanghai Key Translational Xie G Journal of Proteome Research cancer Laboratory of Medicine 2015; 14(2): 1195-1202 Diabetes Mellitus 30 Dose-finding quantitative 18F-FDG PET imaging study with the Imperial College Ovarian Cancer Gungor H J Nucl Med 2015; 56(12): 1828- oral pan-AKT inhibitor GSK2141795 in patients with gynecologic London Action Research 1835 malignancies Centre 31 Urine metabolite profiles predictive of human kidney allograft Weill Cornell Medical Physiology and Suhre K J Am Soc Nephrol 2016; 27(2): status College in Qatar Biophysics 626-636

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 49 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 32 Pancreatic cancer screening using a multiplatform human Kobe University Gastroenterology Sakai A Biomark. Med. 2016; 10(6): 577- serum metabolomics system Graduate School of 586 Medicine 33 Potential usefulness of apolipoprotein A2 isoforms for National Cancer Chemotherapy & Honda K Biomark. Med. 2016; 10(11): screening and risk stratification of pancreatic cancer Center Research Clinical Research 1197-1207 institute 34 Metabolomics in cancer biomarker research Shanghai Jiao Tong Education Key Wang X Curr Pharmacol Rep 2016; 2: 293- University Laboratory of 298 Systems Biomedicine 35 A potential tool for diagnosis of male infertility: Plasma Central South Research Center of Zhou X Talanta 2016; 147: 82-89 metabolomics base on GC-MS University Modernization of Chinese Medicines 36 High fasting insulin concentrations may be a pivotal predictor Kochi Medical School Gastroenterology Masuda K Hepatology Research 2016 [Epub for the severity of hepatic fibrosis beyond the glycemic status in and Hepatology ahead of print] non-alcoholic fatty liver disease patients before development of diabetes mellitus 37 Global and targeted metabolomics of synovial fluid discovers Wenzhou Medical Biochemistry Zheng K Hepatology Research 2016 [Epub special osteoarthritis metabolites University ahead of print]

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 50 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

Reviews

No. Title Institute Department First Author Citation 1 1,5-Anhydroglucitol : A Novel Serum Marker for Screening and Univ. of Pennsylvania Pathology Anne L. Frattali CLIN.CHEM. 1994; 40(11): 1991- Monitoring Diabetes Mellitus? 1993 2 Serum 1,5-anhydroglucitol(1,5AG): New clinical marker for Teikyo University Medicine II Toshikazu Diabetes Res. Clin. Pract. 1994; glycemic control Yamanouchi 24(Suppl.): 261-268 3 Monitoring glycaemic control in diabetic patients Pharmaceutical Medicine 1996; 10: 69-70 4 Intolerancia glicida y diabetes mellitus en el anciano Sixto FT Geriatrika 1997; 13(1): 41-44 5 Laboratory Diagnosis and Monitoring of Diabetes Mellitus Beth Israel Medical Clinical Chemistry Kenneth American Society of Clinical Center Emancipator Pathology 1999; 112(5): 665-674 6 1,5-anhydroglucitol (GlycoMarkTM) as a marker of short-term Ohio State Univ. Dungan KM Expert Rev. Mol. Diagn. 2008; glycemic control and glycemic excursions 8(1): 9-19 7 Serum 1,5-anhydroglucitol (GlycoMark TM): A short term Univ. North Carolina Buse JB Diabetes Technology & glycemic marker Therapeutics 2003; 5(3): 355-363 8 American college of endocrinology pre-diabetes consensus Mount Sinai School of Endocrinology Bloomgarden Diabetes Care 2008; 31(12): conference: Part three Medicine ZT 2404-2409 9 Assessing postprandial glucose using 1,5-anhydroglucitol: An Brigham Young Univ. Nursing Christensen BL J Am Acad Nurse Pract 2009; integrative literature review 21(10): 542-548 10 Difficulties in interpreting HbA1c results Pomeranian Medical Homa K Polskie Archiwum Medycyny Univ. Wewnetrzne J 2010; 120(4): 148- 153 11 Determining Glycemic Control Smith J Advance for nurse practitioners 2010; 17(8): 39-40 12 Beyond hemoglobin A1c - need for additional markers of risk Irl B. Hirsch JAMA 2010; 303(22): 2291-2292 for diabetic microvascular complications 13 The clinical use of hemoglobin A1c Johns Hopkins Univ. Saudek CD J Diabetes Sci Technol 2009; 3(4): 629-634 14 Circulating biomarkers of glycemia in U.S. Air Force Medical True MW J Diabetes Sci Technol 2009; 3(4): and implications for personalized medicine Corps 743-747 15 Reexaming metrics for glucose control University of Internal Medicine Rubinow KB JAMA 2011; 305(11): 1132-1133 Washington 16 The quest for the perfect biomarker of long-term glycemia: Harvard Medical Endocrinology Joo-Pin Foo Metabolism Clinical and new studies, new trials and tribulations Center Experimental 2011; 60: 1651- 1654 17 The roles of glycated albumin as intermediate glycation index Yonsei University Kim KJ Diabetes Metab J 2012; 36: 98- and pathogenic protein Health System 107

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 51 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 18 The challenge of the use of glycemic biomarkers in diabetes: Nutrition at the Metabolism, Wright L.A.-C Diabetes Spectrum 2012; 25(3): Reflecting on Hemoglobin A1C, 1,5-Anhydroglucitol, and the University of Endocrinology 141-148 glycated Fructosamine and Glycated Albumin Washington 19 Predicting outcomes and assessing control with alternate Ohio State University Endocrinology Dungan KM Diabetes Technology & glycemic markers Therapeutics 2012; 14(9): 749- 752 20 1,5-Anhydroglucitol in diabetes mellitus Gangneung Asan Endocrinology and Kim WJ Endocrine 2013; 43: 33-40 Hospital Metabolism 21 Glucose variability Mayo Clinic the Mayo College of Service FJ Diabetes 2013; 62(5): 1398-1404 Medicine 22 Capsule commentary on radin, pitfalls in hemoglobin A1c University of San Francisco VA Kenneth R J Gen Intern Med 2014; 29(2): measurement: When results may be misleading California San Medical Center 363 Francisco 23 Glycated albumin - more than the missing link in the evaluation University of Dinu IR Rom J Diabetes Nutr Metab Dis. of diabetes control Medicine and 2014; 21(2): 137-150 Pharmacy Craiova 24 1,5-anhydroglucitol and glycated albumin in glycemia Municipal Kawanishi Diabetes and Koga M Advances in Clinical Chemistry Hospital Endocrinology 2014; 64: 269-301 25 Beyond HbA1c and glucose: the role of nontraditional glycemic Johns Hopkins Epidemiology Parrinello CM Curr Diab Rep 2014; 14: 548-557 markers in diabetes diagnosis, prognosis, and management University 26 Efficacy of voglibose in type 2 diabetes Kawasaki Medical Internal Medicine Kaku K Expert Opin. Pharmacother. School 2014; 15(8): 1181-1190 27 Glycemic variability: Clinical implications Medwin Hospital Endocrinology Krishna SVS Indian J Endocrinol Metab. 2013; 17(4): 611-619 28 Voglibose: An alpha glucosidase inhibitor Medical College and Medicine Dabhi AS Journal of Clinical and Diagnostic Sir Sayajirao General Research 2013; 7(12): 3023-3027 Hospital 29 Post-prandial hyperglycaemia Indraprastha Apollo ACODE Jindal R JIACM 2013; 14(3-4): 242-246 Hospital 30 Optimizing diabetes management: Comprehensive analysis of Institute of Diabetes Kohnert KD Biology. Medicine. Geography glucose monitoring data and use of better metrics for glycemic Series 2013; 4(72): 6-15 control 31 Overview of current and upcoming strategies implied for the Amity University Amity Institute of Choudhury SR Current Diabetes Reviews 2014; therapy of type 2 diabetes mellitus Rajasthan Biotechnology 10(4): 275-282 32 Short-term intensive insulin therapy at diagnosis in type 2 Sun Yat-sen University Guangdong Weng J Diabetes Metab Res Rev 2014; diabetes: plan for filling the gaps of Medical Science Provincial Key [Epub ahead of print] Laboratory of Diabetology

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 52 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 33 Diet and glycaemia: the markers and their meaning. A report of Unilever R&D Alssema M British Journal of Nutrition 2015; the unilever nutrition workshop 113: 239-248 34 Sodium glucose cotransporter 2 inhibitors Washington State Pharmacotherapy White Jr JR Med Clin N Am 2015; 99: 131- University 143 35 Early phase metabolic research with reference to special Procil Institute for Morrow LA Translational Research Method populations Clinical Research for Diabetes, Obesity and Cardiometabolic Drug Development 2015: 225-242 36 Glycemic variability and oxidative stress: A link between Keio University School Internal Medicine Saisho Y Int. J. Mol. Sci. 2014; 15: 18381- diabetes and cardiovascular disease ? of Medicine 18406 37 Monitoring glycemia in diabetes The Ohio State Endocrinology Healy SJ Med Clin N Am 2015; 99(1): 35- University Wexner 45 Medical Center 38 Utility of different glycemic control metrics for optimizing Institute of Diabetes Kohnert KD World J Diabetes 2015; 6(1): 17- management of diabetes 29 39 Amadori albumin in Rajiv Gandhi Center Diabetes and Neelofar K Indian J Endocrinol Metab. 2015; Endocrinology 19(1): 39-46 40 Insulin initiation: bringing objectivity to choice Bharti Hospital Kalra S Journal of Diabetes & Metabolic Disorders 2015; 14: 17 41 Alternative biomarkers for assessing glycemic control in Inha University Pediatrics Lee JE Ann Pediatr Endocrinol Metab. diabetes: Hospital 2015; 20(2): 74-78 fructosamine, glycated albumin, and 1,5-anhydroglucitol 42 Glycemic variability: How do we measure it and why is it Dong-A Medical Endocrinology and Suh S Diabetes Metab J 2015; 39: 273- important ? Center Metabolism 282 43 Impact of on weight regain University Hohenheim Nutrition Medicine Bosy-Westphal Curr Opin Clin Nutr Metab Care A 2015; 18(4): 389-394 44 Ethnicity considerations in diagnosing glucose disorders The Alfred Hospital Hare MJL Current Diabetes Reviews 2016; 12(1): 51-57 45 The utility and pitfalls of the currently used measures of Vardhman Mahavir Medicine Sharma BD JIACM 2015; 16(3-4): 227-235 glycaemia in the diagnosis and management of diabetes Medical College mellitus 46 Glycemic variability and diabetes complications: Does it University of Hirsch IB Diabetes Care 2015; 38(8): 1610- matter? Of course it dose! Washington School of 1614 Medicine 47 Update on pre-diabetes: Focus on diagnostic criteria and University of Catania Clinical and Pino AD World J Diabetes 2016; 7(18): cardiovascular risk Experimental 423-432 Medicine

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 53 M-7-3A (2017-10-18) GlycoMark Compendium of Evidence

No. Title Institute Department First Author Citation 48 Metrics beyond hemoglobin A1C in diabetes management: University of Medicine Wright L.A.-C Diabetes Technology & Time in range, hypoglycemia, and other parameters Washington Medical Therapeutics 2017; Center 19(Supplement 2): S16-S26

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. 54 M-7-3A (2017-10-18)