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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
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 1
 Device: 2 computer programs - IBMF-1 and IBMF-2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Improving Metabolic Control and Reducing Hypoglycemic Risk in Type 1 Diabetes Mellitus With Biological and Behavioral Feedback

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Evaluation of hemoglobinA1c pre and post computer program intervention [ Time Frame: Over the course of the year of study ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: January 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Computer program IBMF-1 and computer program IBMF-2
Each computer program will be used by subject for two months.
 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 .

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00315939

Locations
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
Boris Kovatchev, PhD
Investigators
Principal Investigator: Boris Kovatchev, Ph.D. University of Virginia, Department of Psychiatric Medicine, Behavioral Medicine Research
  More Information

Publications:

Responsible Party: Boris Kovatchev, PhD, Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT00315939     History of Changes
Other Study ID Numbers: 12126
Study First Received: April 18, 2006
Last Updated: September 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
Diabetes
hypoglycemic episodes

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

ClinicalTrials.gov processed this record on May 23, 2013