Comparison of Insulins Aspart and Lispro in Insulin Pumps
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to compare the glycemic control between insulins aspart and
      lispro 48 to 100 hours after pump infusion line change in subjects with type 1 using diabetes
      using an insulin pump.
    

Detailed description: 
      Continuous subcutaneous insulin infusion (Insulin pump therapy) is a well established tool
      for the management of type 1 diabetes. In clinical trials, insulin pump therapy has been
      shown to have increased efficacy over multiple daily injections. However, the overall
      glycemic control in patients using insulin pumps has been disappointing. The recommended
      duration of "needle use" in insulin pump treatment is 48 hours, based on anecdotal
      observations.

      One of the reasons for the suboptimal control may be that patients do not adhere to the
      advice of changing their pump infusion line every 48 hours. However, it is possible that the
      loss of glycemic control may be related to instability of insulin in the pump/line. In
      addition to premeal loss of control after 48 hours of line change, very little is known about
      post-prandial hyperglycemia leading to loss of efficacy of the insulin via an insulin pump
      bolus. The development of continuous glucose monitoring system (CGMS) and new tests for short
      term fluctuations in glucose control such as 1,5-anhydroglucitol make it easier to evaluate
      the impact of short term loss of control in patients using the insulin pump who delay
      changing their lines.

      The different variables will be compared between the two insulins using a paired t test.

        1. Glycemic control will be will be compared 24 to 100 hours after pump infusion line
           change using CGMS and daily serum 1,5-anhydroglucitol.

        2. Post prandial glycemic excursions in plasma glucose following a standardized breakfast
           48, 72, and 96 hours after a pump infusion line change will be compared.

        3. The used pump infusion line will be collected from the patient and analyzed for insulin
           binding to the plastic, as well as other possible effects that may determine its role in
           loss of glycemic control.

        4. Comparison of some of the markers of coagulation, inflammation, protein glycation and
           oxidative stress 48, 72, and 96 hours after a pump infusion line change.
    

Intervention name(s): Insulin Aspart; Insulin Lispro
Intervention type(s): Drug; Drug
Intervention description(s): Either one of these insulins were given to the patient as the second insulin (depending on which was given as the first one, the other insulin was insulin 2). Patients used this insulin in the same dose as they did prior to entering the study.; Patients were given either insulin Aspart or Lispro in test period 1. Then they were switched to the other insulin in test period 2.
Other intervention name(s): Insulin lispro - insulin Humalog; Insulin aspart - insulin Novolog; Insulin Aspart
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 1 diabetes mellitus; Glycemic control; Continuous subcutaneous insulin infusion; Continuous glucose monitoring system