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Best Timing of Insulin Bolus Before Meals of Different Contents

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ClinicalTrials.gov Identifier: NCT01406496
Recruitment Status : Unknown
Verified February 2013 by Amnon Zung, Kaplan Medical Center.
Recruitment status was:  Recruiting
First Posted : August 1, 2011
Last Update Posted : February 22, 2013
Information provided by (Responsible Party):

June 16, 2011
August 1, 2011
February 22, 2013
August 2011
October 2013   (Final data collection date for primary outcome measure)
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 ]

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.

Same as current
Complete list of historical versions of study NCT01406496 on ClinicalTrials.gov Archive Site
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Best Timing of Insulin Bolus Before Meals of Different Contents
The Effect of Food Content and Optimal Timing of Pre-meal Insulin Bolus on the Postprandial Glycemic Control in Children With Type 1 Diabetes

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.

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Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Type 1 Diabetes Mellitus
Drug: insulin
Three different timings of insulin delivered by a pump
Other Names:
  • Insulin Humalog (generic name Lispro)
  • By Elli Lilly, USA
Experimental: Timing of insulin administration
Intervention: Drug: insulin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
December 2013
October 2013   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
8 Years to 30 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
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Amnon Zung, Kaplan Medical Center
Kaplan Medical Center
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Principal Investigator: Amnon Zung, MD Pediatric Endocrinology Unit, Kaplan Medical Center, affiliated with the Hebrew University of Jerusalem
Kaplan Medical Center
February 2013

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