Best Timing of Insulin Bolus Before Meals of Different Contents

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Type 1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Timing of insulin administration<br> | Drug: insulin<br>* Three different timings of insulin delivered by a pump<br>* Other names: By Elli Lilly, USA;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insulin bolus, glucose excursions, post-prandial, timing, meal content