Post-meal Insulin Dosing With Adjuvant Pre-meal Pramlintide in Children With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to examine the effect of pramlintide given pre-meal
      and insulin given just after a meal vs. standard therapy of pre-meal insulin on post-prandial
      glucose excursions.

      The secondary objective is to examine the effect of pramlintide and insulin on glucagon
      suppression in type 1 diabetes.
    

Detailed description: 
      Following approval by the Institutional Review Board at Baylor College of Medicine 8
      adolescents (6 males, 2 females) with type 1 diabetes were recruited to the open-labeled,
      non-randomized, crossover study. Two male subjects were African American; the remaining
      subjects were all Caucasian. Six subjects were on insulin pump therapy, and the two on
      insulin glargine, self-administered at -90minutes. Subjects had their last meal before 12
      midnight, and stayed at our research center from 7AM until completion of the study at 2PM.
      Study A was done before study B.

      Basal insulin doses of the subjects were kept constant through studies A and B. No subject
      was prescribed pramlintide any time in the past prior to participation in this study.

      Study A:Insulin therapy was continued as per prescribed home regimen without pramlintide.
      Subjects self-administered a rapid-acting insulin analog (aspart or lispro) bolus based on
      their individual insulin: carbohydrate ratio, following which they received 12oz (591ml) of
      Boost High Protein drink (360 calories, 50gms carbohydrate, 12 gms fat) at 9AM (0 minutes).
      The Boost was consumed in 5 - 7 minutes. Blood samples were collected for the analysis of
      blood glucose (BG) levels at -60, -30, -10, and 0 minutes, and every 10 minutes thereafter
      for the first hour, every 20 minutes for the second hour, and every 30 minutes until the
      study ended. Blood samples were also collected throughout the study at multiple time points
      for the analysis of insulin and glucagon levels. Subjects were provided with lunch at 2PM,
      and discharged.

      Study B:The study protocol was identical to study A except 30mcg of pramlintide was
      administered subcutaneously immediately prior to drinking the Boost at 9AM, and no insulin
      was given before the meal but was given 15 minutes after the meal (9:15AM) and the dose was
      reduced by 20%. Study B was conducted within 3 to 4 weeks of study A.
    

Intervention name(s): Insulin; Pramlintide + Insulin
Intervention type(s): Drug; Drug
Intervention description(s): Insulin therapy was continued as per prescribed home regimen without pramlintide. Subjects self-administered a rapid-acting insulin analog (aspart or lispro) bolus based on their individual insulin: carbohydrate ratio, before meal.; 30mcg of pramlintide was administered subcutaneously immediately prior to the meal and insulin was given 15 minutes after the meal. The dose of insulin was reduced by 20%.
Other intervention name(s): aspart or lispro; Pramlintide Acetate
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Pramlintide; Islet Amyloid Polypeptide
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric; juvenile; diabetes mellitus; Pediatric type 1 diabetes mellitus