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

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Other: Bolus timing and dosing

• Registration Number: NCT01209312
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-09-23
• Study First Submitted QC: 2010-09-24
• Study First Posted: 2010-09-27
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-20
• Last Update Posted: 2012-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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%

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
full bolus -20	Bolus timing and dosing	Will administer full insulin bolus 20 minutes prior to meal
Full bolus, T0	Bolus timing and dosing	Will administer full meal bolus at the start of the meal
1/2 bolus, T-20	Bolus timing and dosing	Will only give half the insulin dose 20 minutes before meal
1/2 bolus T0	Bolus timing and dosing	Will give half the amount of insulin at the time of the meal

Primary Outcome Measures

Name	Time	Method
Blood glucose area under the curve	4 hours post-meal

Trial Locations

Locations (1)

Barbara Davis Center for Childhood Diabetes; 🇺🇸 Aurora, Colorado, United States