Best Timing of Insulin Bolus Before Meals of Different Contents

This study is currently recruiting participants.

Verified February 2013 by Kaplan Medical Center

Sponsor:

Information provided by (Responsible Party):

Amnon Zung, Kaplan Medical Center

ClinicalTrials.gov Identifier:

NCT01406496

First received: June 16, 2011

Last updated: February 21, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

June 16, 2011

Last Updated Date

February 21, 2013

Start Date ^ICMJE

August 2011

Estimated Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Post-prandial blood glucose excursions following three different meals and three different timings of insulin bolus. [ Time Frame: outcome measures will be assessed for each particiapant after a week; the overall timeframe for all participants is 18 months ] [ Designated as safety issue: Yes ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01406496 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Best Timing of Insulin Bolus Before Meals of Different Contents

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Type 1 Diabetes Mellitus

Intervention ^ICMJE

Drug: insulin

Three different timings of insulin delivered by a pump

Other Names:

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

Study Arm (s)

Experimental: Timing of insulin administration

Intervention: Drug: insulin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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).

Gender

Both

Ages

8 Years to 30 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Amnon Zung, MD

972-8-9441260

amnon_z@clalit.org.il

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT01406496

Other Study ID Numbers ^ICMJE

PP1

Has Data Monitoring Committee

Yes

Responsible Party

Amnon Zung, Kaplan Medical Center

Study Sponsor ^ICMJE

Kaplan Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Amnon Zung, MD

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

Information Provided By

Kaplan Medical Center

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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