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

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ClinicalTrials.gov Identifier: NCT01209312
Recruitment Status : Completed
First Posted : September 27, 2010
Last Update Posted : November 22, 2012
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE September 23, 2010
First Posted Date  ICMJE September 27, 2010
Last Update Posted Date November 22, 2012
Study Start Date  ICMJE December 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2010)
Blood glucose area under the curve [ Time Frame: 4 hours post-meal ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01209312 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Timing of Pre-meal Insulin Versus Accurate Carbohydrate Counting in Youth With Type 1 Diabetes
Official Title  ICMJE Timing of Pre-meal Insulin Versus Accurate Carbohydrate Counting in Youth With Type 1 Diabetes
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE Other: Bolus timing and dosing
We will be altering the timing and dosages of the prescribed meal bolus.
Study Arms  ICMJE
  • Experimental: full bolus -20
    Will administer full insulin bolus 20 minutes prior to meal
    Intervention: Other: Bolus timing and dosing
  • Experimental: Full bolus, T0
    Will administer full meal bolus at the start of the meal
    Intervention: Other: Bolus timing and dosing
  • Experimental: 1/2 bolus, T-20
    Will only give half the insulin dose 20 minutes before meal
    Intervention: Other: Bolus timing and dosing
  • Experimental: 1/2 bolus T0
    Will give half the amount of insulin at the time of the meal
    Intervention: Other: Bolus timing and dosing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2010)
21
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01209312
Other Study ID Numbers  ICMJE 09-0931
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: H Peter Chase, MD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP