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Clinical Trials/NCT01209312
NCT01209312CompletedNot Applicable

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

University of Colorado, Denver1 site in 1 country21 target enrollmentStarted: December 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
21
Locations
1
Primary Endpoint
Blood glucose area under the curve

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
7 Years to 21 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

1/2 bolus T0

Experimental

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

Intervention: Bolus timing and dosing (Other)

full bolus -20

Experimental

Will administer full insulin bolus 20 minutes prior to meal

Intervention: Bolus timing and dosing (Other)

Full bolus, T0

Experimental

Will administer full meal bolus at the start of the meal

Intervention: Bolus timing and dosing (Other)

1/2 bolus, T-20

Experimental

Will only give half the insulin dose 20 minutes before meal

Intervention: Bolus timing and dosing (Other)

Outcomes

Primary Outcomes

Blood glucose area under the curve

Time Frame: 4 hours post-meal

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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