Best Timing of Insulin Bolus Before Meals of Different Contents

Type 1 Diabetes Mellitus Clinical Trial

Official title:

The Effect of Food Content and Optimal Timing of Pre-meal Insulin Bolus on the Postprandial Glycemic Control in Children With Type 1 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01406496
• Other study ID #: PP1
• Status: Recruiting
• Phase: N/A
• First received: June 16, 2011
• Last updated: February 21, 2013
• Start date: August 2011
• Est. completion date: December 2013

Study information

• Verified date: February 2013
• Source: Kaplan Medical Center
• Contact: Amnon Zung, MD
• Phone: 972-8-9441260
• Email: amnon_z[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Post-meal glucose excursions may contribute to the development of diabetes-related complications. These glucose excursions are affected by the food content of the meal and the timing of insulin injection (or insulin pump-bolus) before meal. The best timing for insulin bolus (by pump) is controversial.

The aim of the study is to examine three different timings of insulin bolus in three types of breakfast meals that contain carbohydrates, carbohydrates + proteins and carbohydrate+ fat. The 3h post-meal glucose excursions will be recorded by continuous glucose monitoring system. The results obtained in the diabetic patients will be compared to those obtained in a group of healthy individuals that will consume similar meals.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 30 Years

Eligibility

Inclusion Criteria:

Diabetes patients:

• Type 1 diabetes

• Age 8 to 20 years

• Both genders

Control group:

• Age 18 to 30 years

• Both genders

Exclusion Criteria:

Diabetes patients:

• Less than a year from the diagnosis of type 1 diabetes

• Less than 6 months from the time of insulin pump introduction

Control group:

• Pregnancy

• Any diagnosed or suspected chronic diseases

• Current or recent (within 1 month) use of drugs (not including oral contraceptives and inhaled steroids for asthma).

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• insulin
Three different timings of insulin delivered by a pump

Locations

Country	Name	City	State
Israel	Pediatric Endocrinology Unit, Kaplan Medical Center	Rehovot

Sponsors (1)

Lead Sponsor	Collaborator
Kaplan Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-prandial blood glucose excursions following three different meals and three different timings of insulin bolus.	Each diabetes patient will be assigned for one of three breakfast meals, differed by their content: carbohydrates, carbohydrates + proteins or carbohydrates + fat. Post-meal blood glucose excursions will be recoded by continuous blood glucose monitoring at three different days. In each day insulin bolus will be administrated at a different timing before meal.; Each healthy participant will consume the three types of breakfast meals at three different days, and post-meal blood glucose excursions will be recoded by continuous blood glucose monitoring.	outcome measures will be assessed for each particiapant after a week; the overall timeframe for all participants is 18 months	Yes