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

This study is currently recruiting participants.

Verified by University of Virginia, February 2006

Sponsored by:	University of Virginia
Information provided by:	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

MedlinePlus related topics: Diabetes Diabetes Type 1

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Non-Randomized, Open Label, Crossover Assignment
Official Title:	Improving Metabolic Control and Reducing Hypoglycemic Risk in Type 1 Diabetes Mellitus With Biological and Behavioral Feedback

Further study details as provided by University of Virginia:

Estimated Enrollment:	120
Study Start Date:	January 2006

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

Contacts

Contact: Pam Mendosa, RN

434-982-6481

pcm9b@virginia.edu

Locations

United States, Virginia
University of Virginia - Behavioral Medicine Research Center	Recruiting
Charlottesville, Virginia, United States, 22908
Principal Investigator: Boris Kovatchev, Ph.D.

Sponsors and Collaborators

University of Virginia

Investigators

Principal Investigator:

Boris Kovatchev, Ph.D.

University of Virginia, Department of Psychiatric Medicine, Behavioral Medicine Research

More Information

Study ID Numbers:	RO1 DK 51562 - 12126
Study First Received:	April 18, 2006
Last Updated:	April 20, 2006
ClinicalTrials.gov Identifier:	NCT00315939
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Virginia:

Diabetes
hypoglycemic episodes

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009