Expired Study
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Aurora, Colorado 80045


Purpose:

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.


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


Study is Available At:


Original ID:

09-0931


NCT ID:

NCT01209312


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

7 Years


Maximum Age:

21 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Colorado, Denver


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

21


Enrollment Type:

Actual


Overall Contact Information

Official Name:H Peter Chase, MD
Principal Investigator
University of Colorado, Denver

Study Dates

Start Date:December 2009
Completion Date:December 2010
Completion Type:Actual
Primary Completion Date:December 2010
Primary Completion Type:Actual
Verification Date:November 2012
Last Changed Date:November 20, 2012
First Received Date:September 23, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:Blood glucose area under the curve
Time Frame:4 hours post-meal
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:Bolus timing and dosing
Description:We will be altering the timing and dosages of the prescribed meal bolus.
Arm Name:full bolus -20

Study Arms

Study Arm Type:Experimental
Arm Name:1/2 bolus T0
Description:Will give half the amount of insulin at the time of the meal
Study Arm Type:Experimental
Arm Name:1/2 bolus, T-20
Description:Will only give half the insulin dose 20 minutes before meal
Study Arm Type:Experimental
Arm Name:Full bolus, T0
Description:Will administer full meal bolus at the start of the meal
Study Arm Type:Experimental
Arm Name:full bolus -20
Description:Will administer full insulin bolus 20 minutes prior to meal

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Colorado, Denver

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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