Additional Insulin for High Fat/Protein in Type 1 Diabetes
Condition: Type 1 Diabetes; Adolescent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Aim: Dietary carbohydrate is the predominant macronutrient affecting postprandial blood
      glucose excursions, dietary fat and protein can also significantly impact the postprandial
      glycemic profile. The aim of this study is to compare the impact of additional dose of
      extended insulin bolus; using Pankowsko algorithm (PA) to usual standard carbohydrate
      counting (CC) on postprandial glucose excursions for high fat /high energy density mixed meal
      for 12 hours.

      Methods: In this single-center, non-blinded, randomized, crossover study a high fat, high
      energy density test meal containing 80 gram carbohydrate (34%), 70 gram fat (66%) and 35 g
      protein (14%) was given using standard carbohydrate counting (CC) on the first test day and
      PA was used for the second test day for the same meal. Two methods were compared on
      postprandial early (0-120 min), late (120-720 min) and total (0-720 min) glucose response in
      20 patients with type 1 diabetes mellitus (T1DM), aged 9-18 years on continuous subcutan
      insulin infusion (CSII) therapy using continuous glucose monitoring system (CGMS).
    

Detailed description: 
      Children and adolescents with T1DM between the ages of 9-18 and undergoing insulin infusion
      pump therapy followed in Ege University Pediatric Endocrinology Department will be randomly
      selected regardless of metabolic control. The selection of the cases will be made from the
      beginning of the study as the first 30 patients who meet the research participation criteria
      and agree to participate in the study. Before the research starts, the cases will be told
      about the application of CGMS, their responsibilities in the research, and an appointment
      will be given for the insertion of CGMS and this procedure will be applied to all
      participants. On the day of the appointment, the participant will be put on CGMS, and as long
      as CGMS is attached, they will be asked to measure capillary blood glucose in their diaries
      and record them. The subjects will be checked whether they are within the target blood
      glucose values for 2 days before consuming the test meal and normoglycemia will be provided.
      On the first day of the study, a test meal with 80 g carbohydrate (29.3%), 70.2 g fat
      (57.9%), 34.7 g protein (12.7%), will be consumed in the evening meal and carbohydrate
      counting-normal bolus insulin will be given by administration. On the second day of the
      study, the additional insulin for fat and protein will be given as a dual wave bolus instead
      of the normal bolus for the test meal. Then, CGMS will be extracted from the cases,
      transferred to the computer, and analysis will be made by the researcher, taking into account
      the capillary blood glucose measurements in the diary.
    

Intervention name(s): Carb and fat counting
Intervention type(s): Other
Intervention description(s): In the 7 days leading up to the study, participants were contacted to review blood glucose levels with CGMS, food and activity diary. basal rates and insulin carbohydrate ratio and sensitivity factor were changed according to the CGMS values and normoglycemia was achieved.In the study day same meals were served which included high fat, high energy density test meal containing 80 gram carbohydrate (34%), 70 gram fat (66%) and 35 g protein (14%).The participants had to have no glucose fluctuations 2 hours before study entry based on CGMS, no correction boluses for at least 4 hours before the test meal consumption and fasting glycemia in the range of 70-180 mg/dL on both study days.The participants received the test meal calculating insulin dose by CC on the first study day and calculating insulin dose by and fat/protein counting in the second study day. The test meal consumption was completed in 20 minutes under supervision by a caregiver and a dietician of the research team
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: type 1 diabetes; dietary fat; high energy density meal; glycemic variability