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NCT00406133 · ClinicalTrials.gov registry record · Phase 3
Randomized Study of Real-Time Continuous Glucose Monitors (RT-CGM) in the Management of Type 1 Diabetes
A Phase 3 study of Type 1 Diabetes, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- Phase 3
- Development phase
- 451
- Enrollment target
- 11
- Study locations
NCT00406133: Completed Phase 3 study of Type 1 Diabetes, sponsored by Jaeb Center for Health Research.
NCT00406133 is a Phase 3 study of Type 1 Diabetes that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 451 participants, below the 764-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (41% lower). The trial reports 11 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00406133, a Phase 3 study of Type 1 Diabetes, has completed, sponsored by Jaeb Center for Health Research.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 451 participants
- Enrollment target
- 11
- Study locations
Study Summary
Subjects with intensively-treated type 1 diabetes and glycated hemoglobin (HbA1c) 7.0%-10.0% in 3 age groups (\>25, 15-24, 8-14) will be randomized to a continuous glucose monitoring (CGM) group or control group. The primary outcome is change in HbA1c after 26 weeks. A parallel randomized trial is being conducted for a second cohort with HbA1c \<7.0% that will follow an identical protocol to that of the first cohort with HbA1c \>=7.0%. The \>=7.0% trial was specifically designed and statistically powered to compare separately the impact of continuous versus standard intensive glucose monitoring in the three age groups. Both trials used standardized treatment algorithms and equivalent frequent contacts with subjects in both the CGM and control group. After completion of the 26-week trial, the CGM group continues to use CGM for another 26 weeks to evaluate whether any beneficial effect seen in the first 6 months is sustained with longer-term use and less intensive contact and the control group initiates CGM use with less intensive contact after the first month than was provided at initiation of CGM use in the CGM group in the randomized trial.
Primary Outcome
The primary outcome was the Change in glycated hemoglobin (HbA1c) from baseline to 26 weeks, as determined by a central laboratory (for the cohort with baseline HbA1c \>=7.0% cohort).
Conditions Studied
Interventions
- DEVICE Continuous glucose monitor
Study Locations (11)
California
- University of Southern California - Beverly Hills
- Kaiser Permanente - San Diego
- Stanford University - Stanford
Massachusetts
- Joslin Diabetes Center - Adults - Boston
- Joslin Diabetes Center - Children - Boston
Colorado
- University of Colorado - Aurora
Connecticut
- Yale University School of Medicine - New Haven
Florida
- Nemours Children's Clinic - Jacksonville
Georgia
- Atlanta Diabetes Associates - Atlanta
Iowa
- Children's Hospital of Iowa - Iowa City
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 451 participants |
| Start Date | 2006-12 |
| Est. Completion | 2009-02 |
| Phase | Phase 3 |
What the finished NCT00406133 record still lists
NCT00406133 is an interventional study that assigns participants to a tested intervention. The registered 451 participants enrollment target is mid-sized for trials with a published cap, below the 764-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (41% lower).
The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 1 intervention - of which Continuous glucose monitor is the first listed.
NCT00406133 lists 11 locations in 8 states (California, Massachusetts, Colorado).
Frequently Asked Questions
What is clinical trial NCT00406133 about?
NCT00406133 is a clinical study titled "Randomized Study of Real-Time Continuous Glucose Monitors (RT-CGM) in the Management of Type 1 Diabetes". Subjects with intensively-treated type 1 diabetes and glycated hemoglobin (HbA1c) 7.0%-10.0% in 3 age groups (\>25, 15-24, 8-14) will be randomized to a continuous glucose monitoring (CGM) group or control group. The primary outcome is change in HbA1c after 26 weeks. A parallel randomized trial is b...
What is the current status of trial NCT00406133?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 451 participants. The study started on 2006-12. Estimated completion is 2009-02.
What conditions does trial NCT00406133 study?
This clinical trial studies the following conditions: Type 1 Diabetes.
What interventions are being tested in trial NCT00406133?
The interventions under investigation include: Continuous glucose monitor (DEVICE).
Who is sponsoring clinical trial NCT00406133?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00406133 being conducted?
This trial has 11 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00406133's enrollment target sits among peer trials
451 20th of 198 higher than 179 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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