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

NCT ID: NCT01209312

Last Updated: 2012-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-12-31

Brief Summary

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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

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Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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full bolus -20

Will administer full insulin bolus 20 minutes prior to meal

Group Type EXPERIMENTAL

Bolus timing and dosing

Intervention Type OTHER

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

Full bolus, T0

Will administer full meal bolus at the start of the meal

Group Type EXPERIMENTAL

Bolus timing and dosing

Intervention Type OTHER

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

1/2 bolus, T-20

Will only give half the insulin dose 20 minutes before meal

Group Type EXPERIMENTAL

Bolus timing and dosing

Intervention Type OTHER

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

1/2 bolus T0

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

Group Type EXPERIMENTAL

Bolus timing and dosing

Intervention Type OTHER

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

Interventions

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Bolus timing and dosing

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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H Peter Chase, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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09-0931

Identifier Type: -

Identifier Source: org_study_id