Status:
COMPLETED
Improving Control and Reducing the Risk of Hypoglycemic Episodes in Type 1 Diabetes
Lead Sponsor:
Boris Kovatchev, PhD
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to test two newly developed computer programs, Integrated Biobehavioral Monitoring and Feedback (IBMF) IBMF-1 and IBMF-2. The computer programs are considered experimental...
Detailed Description
Subjects were randomized into group A or group B matched by gender, age, and baseline HbA1c. Group A began with routine self-monitored blood glucose (SMBG) alone (level 1), followed sequentially by IB...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00315939
Start Date
January 1 2006
End Date
December 1 2009
Last Update
September 18 2014
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22903