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Timing of Pre-meal Insulin Versus Accurate Carbohydrate Counting in Youth With Type 1 Diabetes

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bolus timing and dosing
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

7 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ages 7-21, inclusive
  • Diagnosis of type 1 diabetes for >1 year
  • Using carbohydrate counting to dose mealtime insulin
  • Using an insulin pump and continuous glucose monitor to control diabetes
  • HbA1c <10%

Exclusion Criteria:

  • Celiac disease or other GI abnormality
  • Severe hypoglycemia in the past 6 months
  • Pregnancy
  • Documented hypoglycemia unawareness

Sites / Locations

  • Barbara Davis Center for Childhood Diabetes

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

full bolus -20

Full bolus, T0

1/2 bolus, T-20

1/2 bolus T0

Arm Description

Will administer full insulin bolus 20 minutes prior to meal

Will administer full meal bolus at the start of the meal

Will only give half the insulin dose 20 minutes before meal

Will give half the amount of insulin at the time of the meal

Outcomes

Primary Outcome Measures

Blood glucose area under the curve

Secondary Outcome Measures

Full Information

First Posted
September 23, 2010
Last Updated
November 20, 2012
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT01209312
Brief Title
Timing of Pre-meal Insulin Versus Accurate Carbohydrate Counting in Youth With Type 1 Diabetes
Official Title
Timing of Pre-meal Insulin Versus Accurate Carbohydrate Counting in Youth With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators are hoping to figure out how youth with type 1 diabetes can best control their blood glucose levels after meals, by determining whether accurate carbohydrate dosing or the timing of the bolus is more important. There is evidence to suggest that each strategy is important for blood glucose control. Unfortunately, for some people, prebolusing is difficult, because they may not know how much they are going to eat. To give an exact dose of insulin 20 minutes before a meal can be difficult. In this study, the investigators would like to show that taking even just part of the insulin bolus 20 minutes before the meal is preferable to waiting until mealtime and taking the entire bolus. To do this, the investigators will have 24 patients in the study, who will each spend 4 mornings at The investigators clinic. The order of the visits will be selected randomly. The visits will include: taking full bolus at mealtime, taking full bolus 20 minute before mealtime, taking ½ bolus at mealtime, and taking ½ bolus 20 minutes before mealtime. At each visit, the person will eat the same meal, but the timing and amount of the bolus will be different. The investigators will measure the blood glucose levels with a blood glucose meter, and also with a laboratory test called YSI. The investigators will also be measuring the glucose levels under the person's skin with a continuous glucose monitor. The investigators will compare the area under the curve for the different visits, as well as the glucose levels at different points after the meal.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
full bolus -20
Arm Type
Experimental
Arm Description
Will administer full insulin bolus 20 minutes prior to meal
Arm Title
Full bolus, T0
Arm Type
Experimental
Arm Description
Will administer full meal bolus at the start of the meal
Arm Title
1/2 bolus, T-20
Arm Type
Experimental
Arm Description
Will only give half the insulin dose 20 minutes before meal
Arm Title
1/2 bolus T0
Arm Type
Experimental
Arm Description
Will give half the amount of insulin at the time of the meal
Intervention Type
Other
Intervention Name(s)
Bolus timing and dosing
Intervention Description
We will be altering the timing and dosages of the prescribed meal bolus.
Primary Outcome Measure Information:
Title
Blood glucose area under the curve
Time Frame
4 hours post-meal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages 7-21, inclusive Diagnosis of type 1 diabetes for >1 year Using carbohydrate counting to dose mealtime insulin Using an insulin pump and continuous glucose monitor to control diabetes HbA1c <10% Exclusion Criteria: Celiac disease or other GI abnormality Severe hypoglycemia in the past 6 months Pregnancy Documented hypoglycemia unawareness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H Peter Chase, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barbara Davis Center for Childhood Diabetes
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Timing of Pre-meal Insulin Versus Accurate Carbohydrate Counting in Youth With Type 1 Diabetes

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