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Best Timing of Insulin Bolus Before Meals of Different Contents

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Kaplan Medical Center.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Amnon Zung, Kaplan Medical Center Identifier:
First received: June 16, 2011
Last updated: February 21, 2013
Last verified: February 2013

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:

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 ]

    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


Ages Eligible for Study:   8 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01406496

Contact: Amnon Zung, MD 972-8-9441260

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

Responsible Party: Amnon Zung, MD, Kaplan Medical Center Identifier: NCT01406496     History of Changes
Other Study ID Numbers: PP1
Study First Received: June 16, 2011
Last Updated: February 21, 2013

Keywords provided by Kaplan Medical Center:
Insulin bolus
glucose excursions
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, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on May 23, 2017