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
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 or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Drug: insulin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||October 2013|
|Estimated Study Completion Date :||December 2013|
|Experimental: Timing of insulin administration||
Three different timings of insulin delivered by a pump
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01406496
|Contact: Amnon Zung, MDemail@example.com|
|Pediatric Endocrinology Unit, Kaplan Medical Center||Recruiting|
|Rehovot, Israel, 76100|
|Contact: Amnon Zung, MD 972-8-9441260 firstname.lastname@example.org|
|Principal Investigator: Amnon Zung, MD|
|Sub-Investigator: Nitza Vazana, RN|
|Sub-Investigator: Lilach Hofi, R.Nutr|
|Principal Investigator:||Amnon Zung, MD||Pediatric Endocrinology Unit, Kaplan Medical Center, affiliated with the Hebrew University of Jerusalem|