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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
  Purpose

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.


Condition Intervention
Type 1 Diabetes Mellitus
 Drug: insulin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kaplan Medical Center:

Primary Outcome Measures:
  • 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.



Estimated Enrollment: 24
Study Start Date: August 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Timing of insulin administration Drug: insulin
Three different timings of insulin delivered by a pump
Other Names:
  • Insulin Humalog (generic name Lispro)
  • By Elli Lilly, USA

  Eligibility

Ages Eligible for Study:   8 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406496

Contacts
Contact: Amnon Zung, MD 972-8-9441260 amnon_z@clalit.org.il

Locations
Israel
Pediatric Endocrinology Unit, Kaplan Medical Center Recruiting
Rehovot, Israel, 76100
Contact: Amnon Zung, MD     972-8-9441260     amnon_z@clalit.org.il    
Principal Investigator: Amnon Zung, MD            
Sub-Investigator: Nitza Vazana, RN            
Sub-Investigator: Lilach Hofi, R.Nutr            
Sponsors and Collaborators
Kaplan Medical Center
Investigators
Principal Investigator: Amnon Zung, MD Pediatric Endocrinology Unit, Kaplan Medical Center, affiliated with the Hebrew University of Jerusalem
  More Information

No publications provided

Responsible Party: Amnon Zung, MD, Kaplan Medical Center
ClinicalTrials.gov Identifier: NCT01406496     History of Changes
Other Study ID Numbers: PP1
Study First Received: June 16, 2011
Last Updated: February 21, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by Kaplan Medical Center:
Insulin bolus
glucose excursions
post-prandial
timing
meal content

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013