Effect of Splitting Mealtime Insulin Doses After Mixed Meals High in Fat and Protein

• Status: Not yet recruiting
• Trial end date: 2021-10-31
• Target enrollment: 0
• Participant gender: All

Summary

The current management of type 1 diabetes mellitus (T1DM) depends on the use of intensive insulin therapy - either by insulin pump therapy or multiple daily injection (MDI) therapy - and the use of carbohydrate counting to determine the mealtime bolus insulin dose according the carbohydrate contents of each meal or snack. However, several studies reported that the fat and protein contents of the meals can also affect the postprandial blood glucose levels and result in delayed postprandial hyperglycemia especially after high fat and protein meals.

There is no widely accepted regimen to calculate insulin required for the fat and protein contents of meals especially for patients using multiple daily injection regimen. This study aims to find a better method to cover the increased insulin requirements following mixed fat and protein meals. The study will compare the effect of splitting mealtime bolus insulin doses into pre-meal and post-meal portions to the standard regimen which involve giving bolus dose depending on carbohydrate content only with additional correction doses 2 to 3 hours after the meal to compensate for the postprandial hyperglycemia induced by fat and protein content of the meals.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sohag University
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Children and adolescents aged 6 - 18 years

• diagnosed with T1DM for at least 1 year

• using MDI regimen with advanced carbohydrate counting for at least 6 months

Exclusion Criteria:

• Subjects with associated

• diabetic autonomic neuropathy

• hypothyroidism

• celiac disease.