title: 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.
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.
  
  
  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 micromol/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.
authors.affiliation: University of Washington, Seattle, WA, USA. ihirsch@u.washington.edu
authors.forename: Irl B
authors.initials: IB
authors.lastname: Hirsch
authors.forename: Bruce W
authors.initials: BW
authors.lastname: Bode
authors.forename: Satish
authors.initials: S
authors.lastname: Garg
authors.forename: Wendy S
authors.initials: WS
authors.lastname: Lane
authors.forename: Allen
authors.initials: A
authors.lastname: Sussman
authors.forename: Peter
authors.initials: P
authors.lastname: Hu
authors.forename: Olga M
authors.initials: OM
authors.lastname: Santiago
authors.forename: Jerzy W
authors.initials: JW
authors.lastname: Kolaczynski
mesh_terms: D000328:Adult; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism; D015992:Body Mass Index; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D019270:Fructosamine / Q000097:blood; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007328:Insulin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D061267:Insulin Aspart; D000069036:Insulin Glargine; D007332:Insulin Infusion Systems; D049528:Insulin, Long-Acting; D008297:Male
chemical_list: D015415:Biomarkers; D001786:Blood Glucose; D019270:Fructosamine; D006442:Glycated Hemoglobin; D007328:Insulin; D061267:Insulin Aspart; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting