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Best Timing of Insulin Bolus Before Meals of Different Contents

Primary Purpose

Type 1 Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
insulin
Sponsored by
Kaplan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Insulin bolus, glucose excursions, post-prandial, timing, meal content

Eligibility Criteria

8 Years - 30 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Pediatric Endocrinology Unit, Kaplan Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Timing of insulin administration

Arm Description

Outcomes

Primary Outcome Measures

Post-prandial blood glucose excursions following three different meals and three different timings of insulin bolus.
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.

Secondary Outcome Measures

Full Information

First Posted
June 16, 2011
Last Updated
February 21, 2013
Sponsor
Kaplan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01406496
Brief Title
Best Timing of Insulin Bolus Before Meals of Different Contents
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 Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaplan Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Insulin bolus, glucose excursions, post-prandial, timing, meal content

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Timing of insulin administration
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
insulin
Other Intervention Name(s)
Insulin Humalog (generic name Lispro), By Elli Lilly, USA
Intervention Description
Three different timings of insulin delivered by a pump
Primary Outcome Measure Information:
Title
Post-prandial blood glucose excursions following three different meals and three different timings of insulin bolus.
Description
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.
Time Frame
outcome measures will be assessed for each particiapant after a week; the overall timeframe for all participants is 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amnon Zung, MD
Phone
972-8-9441260
Email
amnon_z@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amnon Zung, MD
Organizational Affiliation
Pediatric Endocrinology Unit, Kaplan Medical Center, affiliated with the Hebrew University of Jerusalem
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Endocrinology Unit, Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amnon Zung, MD
Phone
972-8-9441260
Email
amnon_z@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Amnon Zung, MD
First Name & Middle Initial & Last Name & Degree
Nitza Vazana, RN
First Name & Middle Initial & Last Name & Degree
Lilach Hofi, R.Nutr

12. IPD Sharing Statement

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Best Timing of Insulin Bolus Before Meals of Different Contents

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