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

NCT01209312 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2012-11-22

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Bolus timing and dosing

We will be altering the timing and dosages of the prescribed meal bolus.

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • H Peter Chase, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
7 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01209312 on ClinicalTrials.gov