Glycomark Compendium of Evidence
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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 insulin-dependent diabetes 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 glucose 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 Endocrinology and Iwamoto Y Korea Japan Symp.D.M. 1991; insulin-dependent diabetes Mellitus Metabolism 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 fasting 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" hyperglycemia 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): fructosamine 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 Pathology 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 glucose tolerance test 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 acarbose 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 sulfonylurea 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