N/A
Completed N=120
Improving Control and Reducing the Risk of Hypoglycemic Episodes in Type 1 Diabetes
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT00315939 ↗
Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: Hemoglobin A1c — 7.99; 7.69; 7.69; 7.58 percentage of glycated hemoglobin — p==0.001
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. Both computer programs are being tested to see if they are useful in helping people with type 1 diabetes avoid low blood sugar episodes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin A1c |
7.99; 7.69; 7.69; 7.58 | =0.001 sig |
| PRIMARY Frequency of Severe Hypoglycemia |
0.09; 0.21; 0.15; 0.02 | — |
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT00315939). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.