title: Glycemic control after 6 days of insulin pump reservoir use in type 1 diabetes: results of double-blind and open-label cross-over trials of insulin lispro and insulin aspart.
abstract: BACKGROUND
  The objective of the current study was to assess mean self-monitored blood glucose (SMBG), on day 6 of 6 days of continuous reservoir wear (6D), with insulin lispro (Lis) or insulin aspart (Asp).
  
  
  METHODS
  Two 24-week, randomized trials were conducted in subjects with type 1 diabetes treated by continuous subcutaneous insulin infusion (CSII) for ≥6 months, with a mean total daily insulin dose capable of supporting 6 days of in-reservoir use. Study 1 had an open-label, six-sequence, three-treatment, three-period, cross-over design. Study 2 had a double-blind, two-sequence, two-treatment, two-period, cross-over design. The primary efficacy measure was the mean of Day 6, seven-point SMBG profiles for insulin lispro 6D (Lis6D) and insulin aspart 6D (Asp6D) treatment periods. Safety measures were also assessed.
  
  
  RESULTS
  Lis did not achieve noninferiority (SMBG; margin = 0.6 mmol/L [10.8 mg/dL]) to Asp on Day 6 of reservoir wear in either Study (least-squares mean difference: Study 1 = 0.48 mmol/L [8.64 mg/dL]; 95% confidence interval [CI] [0.20, 0.76], Study 2 = 0.36 mmol/L [6.49 mg/dL]; 95% CI [0.06, 0.66]). Noninferiority was demonstrated for overall daily mean of SMBG values over days 1 to 6 of reservoir use during each treatment period. In the Lis treatment period, subjects reported a lower documented and total hypoglycemia rate per 30 days and a higher rate of non-explained hyperglycemia than in the Asp treatment period.
  
  
  CONCLUSIONS
  While the mean blood glucose on Day 6 of Lis6D did not meet non-inferiority, the overall daily mean blood glucose was not different, with a decreased rate of hypoglycemia with Lis.
authors.affiliation: Department of Pediatrics, Yale School of Medicine, New Haven, Connecticut.
authors.forename: William V
authors.initials: WV
authors.lastname: Tamborlane
authors.forename: Eric
authors.initials: E
authors.lastname: Renard
authors.forename: R Paul
authors.initials: RP
authors.lastname: Wadwa
authors.forename: Thomas
authors.initials: T
authors.lastname: Blevins
authors.forename: Scott J
authors.initials: SJ
authors.lastname: Jacober
authors.forename: Rong
authors.initials: R
authors.lastname: Liu
authors.forename: Deborah N
authors.initials: DN
authors.lastname: D'Souza
authors.forename: Tina M
authors.initials: TM
authors.lastname: Rees
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000032:analysis; D015190:Blood Glucose Self-Monitoring; D002681:China; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006943:Hyperglycemia / Q000517:prevention & control*; D007003:Hypoglycemia / Q000517:prevention & control*; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D061267:Insulin Aspart / Q000627:therapeutic use*; D007332:Insulin Infusion Systems; D061268:Insulin Lispro / Q000627:therapeutic use*; D008297:Male; D019518:Postprandial Period; D011379:Prognosis; D012307:Risk Factors
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D061268:Insulin Lispro; D061267:Insulin Aspart
keywords: Type 1 diabetes; insulin aspart; insulin infusion; insulin lispro; 关键词：门冬胰岛素，胰岛素输注，赖脯胰岛素，1型糖尿病