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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01209312
First received: September 23, 2010
Last updated: November 20, 2012
Last verified: November 2012
  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.


Condition Intervention
Type 1 Diabetes
Other: Bolus timing and dosing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Timing of Pre-meal Insulin Versus Accurate Carbohydrate Counting in Youth With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Blood glucose area under the curve [ Time Frame: 4 hours post-meal ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: December 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: full bolus -20
Will administer full insulin bolus 20 minutes prior to meal
Other: Bolus timing and dosing
We will be altering the timing and dosages of the prescribed meal bolus.
Experimental: Full bolus, T0
Will administer full meal bolus at the start of the meal
Other: Bolus timing and dosing
We will be altering the timing and dosages of the prescribed meal bolus.
Experimental: 1/2 bolus, T-20
Will only give half the insulin dose 20 minutes before meal
Other: Bolus timing and dosing
We will be altering the timing and dosages of the prescribed meal bolus.
Experimental: 1/2 bolus T0
Will give half the amount of insulin at the time of the meal
Other: Bolus timing and dosing
We will be altering the timing and dosages of the prescribed meal bolus.

  Eligibility

Ages Eligible for Study:   7 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01209312

Locations
United States, Colorado
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: H Peter Chase, MD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01209312     History of Changes
Other Study ID Numbers: 09-0931
Study First Received: September 23, 2010
Last Updated: November 20, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014