NCT02685449

Insulin Requirement for Pure-protein Meal in Children With Type 1 Diabetes on Insulin Pumps.

Insulin Requirement for Pure- Protein Meal in Children With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion - a Cross-over, Randomized Trial.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, cross-over study. The aim of this study is to compare the post-prandial glycaemic variability after pure protein meal following with an administration of square-wave bolus of meal-insulin or without any meal-insulin bolus on the other day. Prolonged post-prandial glycaemic variability will be identified using the self-monitoring of blood glucose (10-point curve) and CGMS.

Detailed description

The square-wave bolus (for meals rich in fat and/or protein) is evenly delivered over several hours as programmed by the patient. The required insulin dose will be calculated based on patient's insulin-exchange ratio. Pure protein meal will be given 3 hours after a first breakfast. To provide the minimal impact of the previous breakfast, all patients will receive up to 120 kcal of carbohydrates and \<100 kcal from protein and fat for the first breakfast (without any extended bolus) Patients receive a standardized pure protein meal at a second breakfast time. Meal insulin will be given as a square bolus or no meal -insulin will be given at all. The 5h post-meal glucose excursions will be recorded by self-blood glucose measurements (SMBG) (every 30 minutes) and continuous glucose monitoring system (CGMS). The intervention is taking part under in-patient clinical conditions.

Conditions

• Diabetes type1

Interventions

Type	Name	Description
DRUG	Insulin glulisine	A kind of study bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial
DRUG	Insulin aspart	A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial
DRUG	Insulin lispro	A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial

Timeline

• Start date: 2016-02-01
• Primary completion: 2018-02-01
• Completion: 2018-08-01
• First posted: 2016-02-18
• Last updated: 2016-07-29

Locations

1 site across 1 country: Poland