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NCT00552734 · ClinicalTrials.gov registry record
Improved Glycemic Control in Adult Subjects With Type 1 Diabetes on MDI Using Insulin Guidance Software
A clinical trial, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- 123
- Enrollment target
NCT00552734: Completed study, sponsored by University of Colorado, Denver.
NCT00552734 is a clinical trial that has completed, run by University of Colorado, Denver. The registered enrollment target is 123 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00552734 has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- 123 participants
- Enrollment target
Study Summary
140 subjects will be enrolled into the clinical study and randomized into the Control Group or the Experimental Group by block randomization. The subjects must meet all inclusion and none of the exclusion criteria. Each subject will have 7 clinic visits and 3 phone visits. The Baseline Visit will consist of a complete history, vitals, a physical examination and completion of the consent and screening process. All clinic visits, except for the Baseline Visit will include meter/PDA download. In addition, meter education will be provided to all subjects, and PDA education will be provided to the Experimental group at the Baseline Visit and 2-Week Visit as needed to ensure subject understanding. The phone visits will consist of a history including any changes in insulin dose, and any hypoglycemic events, hyperglycemic events, or other adverse events that have occurred since the last clinic visit. The primary endpoint in this study was to show a reduction in A1c of at least 0.4% or higher in the insulin guidance software group at 6 months and/or 1 year.
Interventions
- DEVICE Insulin Guidance Software
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2005-07 |
| Est. Completion | 2007-05 |
What the finished NCT00552734 record still lists
NCT00552734 is an observational study that tracks outcomes without assigning an intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Insulin Guidance Software is the first listed.
NCT00552734 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00552734 about?
NCT00552734 is a clinical study titled "Improved Glycemic Control in Adult Subjects With Type 1 Diabetes on MDI Using Insulin Guidance Software". 140 subjects will be enrolled into the clinical study and randomized into the Control Group or the Experimental Group by block randomization. The subjects must meet all inclusion and none of the exclusion criteria. Each subject will have 7 clinic visits and 3 phone visits. The Baseline Visit will co...
What is the current status of trial NCT00552734?
This trial is currently completed. The enrollment target is 123 participants. The study started on 2005-07. Estimated completion is 2007-05.
What interventions are being tested in trial NCT00552734?
The interventions under investigation include: Insulin Guidance Software (DEVICE).
Who is sponsoring clinical trial NCT00552734?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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