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Improving Control and Reducing the Risk of Hypoglycemic Episodes in Type 1 Diabetes (BPK002)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boris Kovatchev, PhD, University of Virginia
ClinicalTrials.gov Identifier:
NCT00315939
First received: April 18, 2006
Last updated: September 14, 2011
Last verified: September 2011
History of Changes

April 18, 2006
September 14, 2011
January 2006
December 2009   (final data collection date for primary outcome measure)
Evaluation of hemoglobinA1c pre and post computer program intervention [ Time Frame: Over the course of the year of study ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00315939 on ClinicalTrials.gov Archive Site
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Improving Control and Reducing the Risk of Hypoglycemic Episodes in Type 1 Diabetes
Improving Metabolic Control and Reducing Hypoglycemic Risk in Type 1 Diabetes Mellitus With Biological and Behavioral Feedback

The purpose of this study is to test two newly developed computer programs, IBMF-1 and IBMF-2. The computer programs are considered experimental. Both computer programs are being tested to see if they are useful in helping people with type 1 diabetes avoid low blood sugar episodes.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Diabetes Mellitus, Type 1
Device: 2 computer programs - IBMF-1 and IBMF-2
Use of an experimental computer program IBMF-1 for 2 months and the use of an experimental computer program IBMF-2 for 2 months are the interventions done during the year .
Experimental: Computer program IBMF-1 and computer program IBMF-2
Each computer program will be used by subject for two months.
Intervention: Device: 2 computer programs - IBMF-1 and IBMF-2
Kovatchev BP, Mendosa P, Anderson S, Hawley JS, Ritterband LM, Gonder-Frederick L. Effect of automated bio-behavioral feedback on the control of type 1 diabetes. Diabetes Care. 2011 Feb;34(2):302-7. Epub 2011 Jan 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years of age or older
  • Have type 1 diabetes as defined by the American Diabetes Association or by the judgment of the physician
  • Willing to participate for up to one year
  • Perform routine blood glucose checks 3-4 times a day
  • Complete monthly diaries of the occurrence of severe and moderate hypoglycemic episodes
  • Have 6 hemoglobin A1c (HgbA1c) drawn
  • Have a mixed meal tolerance test to assess for residual pancreatic insulin secretion

Exclusion Criteria:

  • Age < 18 years
  • Currently abusing alcohol or drugs
  • Severe depression or psychosis
  • Significant mental impairment
  • Inability to use a glucometer and a hand held computer
  • Pregnant or desire to achieve pregnancy within the following year (females)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00315939
12126
No
Boris Kovatchev, PhD, University of Virginia
Boris Kovatchev, PhD
Not Provided
Principal Investigator: Boris Kovatchev, Ph.D. University of Virginia, Department of Psychiatric Medicine, Behavioral Medicine Research
University of Virginia
September 2011

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