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
- Irl B. Hirsch, MD1,
- Bruce W. Bode, MD2,
- Satish Garg, MD3,
- Wendy S. Lane, MD4,
- Allen Sussman, MD5,
- Peter Hu, PhD6,
- Olga M. Santiago, MD6,
- Jerzy W. Kolaczynski, MD7 and
- for the Insulin Aspart CSII/MDI Comparison Study Group
- 1University of Washington, Seattle, Washington
- 2Atlanta Diabetes Associates, Atlanta, Georgia
- 3Barbara Davis Center for Childhood Diabetes, Denver, Colorado
- 4Mountain Diabetes and Endocrine Center, Asheville, North Carolina
- 5Rainier Clinical Research Center, Renton, Washington
- 6Novo Nordisk Pharmaceuticals, Princeton, New Jersey
- 7University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, New Brunswick, New Jersey
- 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: ihirsch{at}u.washington.edu
Abstract
OBJECTIVE—Multiple daily injection (MDI) therapy of bolus insulin aspart and basal insulin glargine was compared with continuous subcutaneous insulin infusion (CSII) with aspart in type 1 diabetic patients previously treated with CSII.
RESEARCH DESIGN AND METHODS—One hundred patients were enrolled in a randomized, multicenter, open-label, crossover study. After a 1-week run-in period with aspart 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 treatment, subjects crossed over to the alternate treatment for 5 weeks. During the last week of each treatment period, subjects wore a continuous glucose monitoring system for 48–72 h.
RESULTS—Mean serum fructosamine levels were significantly lower after CSII therapy than after MDI therapy (343 ± 47 vs. 355 ± 50 μmol/l, respectively; P = 0.0001). Continuous glucose monitoring profiles over a 24-h time period showed that glucose exposure was 24 and 40% lower for CSII than MDI as measured by area under the curve (AUC) glucose ≥80 mg/dl (1,270 ± 742 vs. 1,664 ± 1,039 mg · h · dl−1; P < 0.001) and AUC glucose ≥140 mg/dl (464 ± 452 vs. 777 ± 746 mg · h · dl−1, CSII vs. MDI, respectively; P < 0.001). Similar percentages of subjects reported hypoglycemic episodes (CSII: 92%, MDI: 94%) and nocturnal (12:00 a.m. to 8:00 a.m.) hypoglycemic episodes (CSII: 73%, MDI: 72%). Major hypoglycemia was infrequent (CSII: two episodes, MDI: five episodes).
CONCLUSIONS—In a trial of short duration, CSII therapy with insulin aspart resulted in lower glycemic exposure without increased risk of hypoglycemia, as compared with MDI with insulin aspart and glargine.
- AUC, area under the curve
- CGMS, continuous glucose monitoring system
- CSII, continuous subcutaneous insulin infusion
- MDI, multiple daily injection
- SMBG, self-measured blood glucose
Footnotes
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I.R.H. is a paid consultant for Aventis, Eli Lilly, Medtronic, and Novo Nordisk and has received grants from Novo Nordisk and Pfizer; B.W.B. is a paid consultant for Medtronic, Novo Nordisk, and Aventis and has received grants from Novo Nordisk, Aventis, and Medtronic; S.G. has received grants from Novo Nordisk; and W.L. has received honoraria from Aventis and Novo Nordisk.
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
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- Accepted November 20, 2004.
- Received May 2, 2004.
- DIABETES CARE
