Best Timing of Insulin Bolus Before Meals of Different Contents

Kaplan Medical Center

Status: Unknown

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT01406496

PP1

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 8 to 30 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Timing of insulin administration

Experimental group

Treatment:

Drug: insulin