- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01406496
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.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amnon Zung, MD
- Phone Number: 972-8-9441260
- Email: amnon_z@clalit.org.il
Study Locations
-
-
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Rehovot, Israel, 76100
- Recruiting
- Pediatric Endocrinology Unit, Kaplan Medical Center
-
Principal Investigator:
- Amnon Zung, MD
-
Contact:
- Amnon Zung, MD
- Phone Number: 972-8-9441260
- Email: amnon_z@clalit.org.il
-
Sub-Investigator:
- Nitza Vazana, RN
-
Sub-Investigator:
- Lilach Hofi, R.Nutr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Timing of insulin administration
|
Three different timings of insulin delivered by a pump
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
outcome measures will be assessed for each particiapant after a week; the overall timeframe for all participants is 18 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amnon Zung, MD, Pediatric Endocrinology Unit, Kaplan Medical Center, affiliated with the Hebrew University of Jerusalem
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PP1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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