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
  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:


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
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: 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 July 26, 2014