Improving Control and Reducing the Risk of Hypoglycemic Episodes in Type 1 Diabetes - Full Text View

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

This study has been completed.

First Received on April 18, 2006. Last Updated on September 14, 2011 History of Changes

Sponsor:	Boris Kovatchev, PhD
Information provided by (Responsible Party):	Boris Kovatchev, PhD, University of Virginia
ClinicalTrials.gov Identifier:	NCT00315939

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Medicines Diabetes Type 1

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:

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.

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 February 09, 2012