Best Timing of Insulin Bolus Before Meals of Different Contents

Kaplan Medical Center24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes Mellitus

Interventions

Eligibility

Sex: ALLMin age: 8 YearsMax age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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.

Time frame: outcome measures will be assessed for each particiapant after a week; the overall timeframe for all participants is 18 months