Best Timing of Insulin Bolus Before Meals of Different Contents

NCT ID: NCT01406496

Last Updated: 2013-02-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-12-31

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Timing of insulin administration

Group Type: EXPERIMENTAL

insulin

Intervention Type: DRUG

Three different timings of insulin delivered by a pump

Interventions

insulin

Three different timings of insulin delivered by a pump

Intervention Type: DRUG

Other Intervention Names

Insulin Humalog (generic name Lispro); By Elli Lilly, USA

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).

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kaplan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Amnon Zung

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amnon Zung, MD

Role: PRINCIPAL_INVESTIGATOR

Pediatric Endocrinology Unit, Kaplan Medical Center, affiliated with the Hebrew University of Jerusalem

Locations

Pediatric Endocrinology Unit, Kaplan Medical Center

Rehovot, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Amnon Zung, MD

Role: CONTACT

amnon_z@clalit.org.il

972-8-9441260

Facility Contacts

Amnon Zung, MD

Role: primary

amnon_z@clalit.org.il

972-8-9441260

Other Identifiers

PP1

Identifier Type: -

Identifier Source: org_study_id