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Continuous Subcutaneous Insulin Infusion

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Continuous Subcutaneous Insulin Infusion Clinical Care/Education/Nutrition ORIGINAL ARTICLE Continuous Subcutaneous Insulin Infusion (CSII) of Insulin Aspart Versus Multiple Daily Injection of Insulin Aspart/Insulin Glargine in Type 1 Diabetic Patients Previously Treated With CSII 1 6 IRL B. HIRSCH, MD PETER HU, PHD ultiple daily injection (MDI) ther- 2 6 BRUCE W. BODE, MD OLGA M. SANTIAGO, MD apy and continuous subcutane- 3 7 SATISH GARG, MD JERZY W. KOLACZYNSKI, MD 4 ous insulin infusion (CSII) with ENDY ANE MD FOR THE NSULIN SPART M W S. L , I A CSII/MDI 5 an external pump are two current meth- ALLEN SUSSMAN, MD COMPARISON STUDY GROUP ods of intensive insulin therapy for diabe- tes. MDI therapy requires bolus injection of short- or rapid-acting insulin at each OBJECTIVE — Multiple daily injection (MDI) therapy of bolus insulin aspart and basal meal, along with long-acting insulin once insulin glargine was compared with continuous subcutaneous insulin infusion (CSII) with aspart or twice daily for basal insulin coverage. in type 1 diabetic patients previously treated with CSII. Rapid-acting insulin analogs are adminis- tered as mealtime boluses to control post- RESEARCH DESIGN AND METHODS — One hundred patients were enrolled in a prandial glycemic excursions and have randomized, multicenter, open-label, crossover study. After a 1-week run-in period with aspart been shown to be more effective than reg- by CSII, 50 subjects were randomly assigned to MDI therapy (aspart immediately before each meal and glargine at bedtime) and 50 subjects continued CSII. After 5 weeks of the first treat- ular human insulin (1,2). The long-acting ment, subjects crossed over to the alternate treatment for 5 weeks. During the last week of each insulin analog insulin glargine has pro- treatment period, subjects wore a continuous glucose monitoring system for 48–72 h. longed pharmacodynamics that make it suitable for use as a basal insulin (3,4). RESULTS — Mean serum fructosamine levels were significantly lower after CSII therapy than The growing use of CSII therapy is after MDI therapy (343 Ϯ 47 vs. 355 Ϯ 50 ␮mol/l, respectively; P ϭ 0.0001). Continuous based on its proven efficacy, improve- glucose monitoring profiles over a 24-h time period showed that glucose exposure was 24 and ments in pump technology, and increased 40% lower for CSII than MDI as measured by area under the curve (AUC) glucose Ն80 mg/dl Ϫ patient preference (5–10). Occasionally, (1,270 Ϯ 742 vs. 1,664 Ϯ 1,039 mg ⅐ h ⅐ dl 1; P Ͻ 0.001) and AUC glucose Ն140 mg/dl (464 Ϯ Ϫ1 patients utilizing CSII therapy may have 452 vs. 777 Ϯ 746 mg ⅐ h ⅐ dl , CSII vs. MDI, respectively; P Ͻ 0.001). Similar percentages of subjects reported hypoglycemic episodes (CSII: 92%, MDI: 94%) and nocturnal (12:00 A.M.to to temporarily discontinue CSII use be- 8:00 A.M.) hypoglycemic episodes (CSII: 73%, MDI: 72%). Major hypoglycemia was infrequent cause of pump malfunction, skin prob- (CSII: two episodes, MDI: five episodes). lems, or physical activity (especially contact sports and water sports). During CONCLUSIONS — In a trial of short duration, CSII therapy with insulin aspart resulted in such periods, type 1 diabetic patients lower glycemic exposure without increased risk of hypoglycemia, as compared with MDI with switching to MDI therapy could continue insulin aspart and glargine. to use insulin aspart as the mealtime in- Diabetes Care 28:533–538, 2005 sulin and could use insulin glargine as the ●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●● basal insulin. Previous studies have shown that From the 1University of Washington, Seattle, Washington; the 2Atlanta Diabetes Associates, Atlanta, Georgia; the 3Barbara Davis Center for Childhood Diabetes, Denver, Colorado; the 4Mountain Diabetes and Endo- CSII is at least equivalent to, and often crine Center, Asheville, North Carolina; the 5Rainier Clinical Research Center, Renton, Washington; 6Novo more effective than, MDI therapy (10– Nordisk Pharmaceuticals, Princeton, New Jersey; and the 7University of Medicine and Dentistry of New 12). The use of an analog-only MDI regi- Jersey, Robert Wood Johnson Medical School, New Brunswick, New Jersey. men consisting of basal glargine and Address correspondence and reprint requests to Irl B. Hirsch, MD, University of Washington Medical Center, 1959 NE Pacific St., Box 356176, Seattle, WA 98195. E-mail: [email protected]. mealtime rapid-acting analog has been Received for publication 2 May 2004 and accepted in revised form 20 November 2004. nicknamed “poor man’s pump.” How- I.R.H. is a paid consultant for Aventis, Eli Lilly, Medtronic, and Novo Nordisk and has received grants ever, its safety and efficacy compared with from Novo Nordisk and Pfizer; B.W.B. is a paid consultant for Medtronic, Novo Nordisk, and Aventis and CSII has never been tested in a controlled, has received grants from Novo Nordisk, Aventis, and Medtronic; S.G. has received grants from Novo cross-over clinical trial setting. Conse- Nordisk; and W.L. has received honoraria from Aventis and Novo Nordisk. Abbreviations: AUC, area under the curve; CGMS, continuous glucose monitoring system; CSII, con- quently, we compared insulin aspart as tinuous subcutaneous insulin infusion; MDI, multiple daily injection; SMBG, self-measured blood glucose. the only approved rapid-acting analog for A table elsewhere in this issue shows conventional and Syste`me International (SI) units and conversion CSII with insulin aspart/glargine in MDI factors for many substances. therapy. Because the principles applied to © 2005 by the American Diabetes Association. The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby mealtime coverage were identical during marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this fact. both treatments, the study tests whether DIABETES CARE, VOLUME 28, NUMBER 3, MARCH 2005 533 CSII versus MDI in type 1 diabetes the theoretically smooth profile of unit-for-unit basis, to MDI therapy using CGMS data. The sensor failure rate was glargine will provide safety and efficacy a single basal bedtime injection of insulin ϳ20%. Glucose exposures were com- comparable to the “customized” basal in- glargine (Lantus, Aventis Pharmaceuti- pared between treatment groups and sulin delivery that can be programmed by cals), consistent with product labeling in were based on the first 24 h of CGMS an infusion pump during CSII. the U.S. at that time, and mealtime bo- monitoring. The 24-h glycemic profiles luses of insulin aspart delivered by the were calculated from the area under the RESEARCH DESIGN AND Induo device. Subjects assigned to CSII curve (AUC) for glucose values Ն80 METHODS — This was a multicenter, treatment during the study used their mg/dl (4.4 mmol/l) and Ն140 mg/dl (7.8 open-label, randomized, two-period, own prestudy insulin pumps. mmol/l). CGMS profiles had to be at least crossover, 10-week study in which CSII In both groups, the basal insulin cov- 24 h in duration to be suitable for use in was compared with MDI therapy in two erage could be modified through the sched- the AUC calculations. For the CGMS data 5-week treatment periods. The study was uled phone communications with the analysis, glycemia of 80 mg/dl was the conducted at 15 centers in the U.S., in subject during a 1-week dose-adjustment minimal value considered optimal. Ac- accordance with the Declaration of Hel- period with a goal of fasting and pre- cordingly, glycemic control was consid- sinki and good clinical practice guidelines dinner glycemia in the range of 90–126 ered to be better/tighter when the glucose (13). All subjects provided written in- mg/dl (5–7 mmol/l). The investigator exposure of AUC Ն80 mg/dl was mini- formed consent. Analyses of blood sam- made final adjustments to the basal insu- mized in a treatment regimen. ples for safety and efficacy parameters lin dose at the visit scheduled for the end were performed by Medical Research Lab- of the 1-week dose-adjustment period, af- Safety assessments oratories International (Highland ter which the adjusted basal insulin rate/ Safety assessments included adverse Heights, KY). dose was maintained for the remaining 4 events, physical examination findings, Enrolled type 1 diabetic subjects were weeks of the treatment period. At the end and clinical laboratory evaluations. Ad- Ն18 years old, had BMI Յ40 kg/m2, and of the 5-week treatment period, subjects verse events were recorded throughout Յ had HbA1c 9%. All were previously crossed over to the alternate treatment ther- the study, and a general physical exami- treated by CSII for at least 3 months be- apy (e.g., CSII to MDI), with a 1-week nation was conducted at the beginning fore the screening visit. Subjects with im- basal dose adjustment period immedi- and end of the study. paired hepatic or renal function (alanine ately followed by 4 weeks of treatment. The frequency of hypoglycemic epi- aminotransferase or creatinine values Ն2 sodes was monitored. Minor hypogly- times the upper limit of the normal refer- Efficacy assessments cemic episodes were defined as any ence range for the age-group), impaired Overall glycemic control was assessed by asymptomatic blood glucose measure- cardiac function, hypoglycemia unaware- fructosamine measurements taken at the ment Ͻ50 mg/dl, or as episodes with ness, or recurrent major hypoglycemia beginning and end of each treatment pe- symptoms consistent with hypoglycemia were excluded. Subjects performed self- riod (normal fructosamine range: 0–285 with confirmation by blood glucose mea- ␮ Ͻ measured blood glucose (SMBG) mea- mol/l). HbA1c values were measured at surement 50 mg/dl that were handled surements and were knowledgeable in the the beginning and end of the study (nor- by the subject.
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