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NCT01271023 · ClinicalTrials.gov registry record · Phase 1
Inpatient Evaluation of an Automated Closed-Loop Control-to-Range System
A Phase 1 study of Type 1 Diabetes, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
- 7
- Study locations
NCT01271023: Completed Phase 1 study of Type 1 Diabetes, sponsored by Jaeb Center for Health Research.
NCT01271023 is a Phase 1 study of Type 1 Diabetes that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 57 participants, below the 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (93% lower). The trial reports 7 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01271023, a Phase 1 study of Type 1 Diabetes, has completed, sponsored by Jaeb Center for Health Research.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of this study is to test an insulin management system ("Control-to-Range (CTR) system") in an inpatient setting to see if the system is safe and effective enough to test in a future at-home study. The system includes (1) a DexCom Seven Plus Continuous Glucose Monitoring (CGM) device that measures the blood sugar, (2) a laptop computer that determines how much insulin is needed, and (3) an Insulet OmniPod insulin pump that delivers the insulin. The study will include two hospital stays consisting of meals and exercise scenarios. Both hospital stays will be for 24+ hours during the day and night. The study will include about 50 individuals at 7 clinical centers in the United States, France, Israel, and Italy.
Primary Outcome
Group success criterion defined as a mean blood glucose \>50%, lower end of one-sided 95% confidence interval \>40% and individual criterion of no individual \<30%.
Conditions Studied
Interventions
- DEVICE Control-to-Range Automated Insulin Management System
Study Locations (7)
Other
- Montpellier University Hospital - Montpellier
- Schneider Children's Medical Center of Israel - Petah Tikva
- University of Padova - Padua
California
- Sansum Diabetes Research Institute - Santa Barbara
- Stanford University - Stanford
Colorado
- University of Colorado Health Sciences Center- Barbara Davis - Aurora
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2011-03 |
| Est. Completion | 2012-08 |
| Phase | Phase 1 |
What the finished NCT01271023 record still lists
NCT01271023 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 1 intervention - of which Control-to-Range Automated Insulin Management System is the first listed.
NCT01271023 lists 7 locations in 4 states (Other, California, Colorado).
Frequently Asked Questions
What is clinical trial NCT01271023 about?
NCT01271023 is a clinical study titled "Inpatient Evaluation of an Automated Closed-Loop Control-to-Range System". The purpose of this study is to test an insulin management system ("Control-to-Range (CTR) system") in an inpatient setting to see if the system is safe and effective enough to test in a future at-home study. The system includes (1) a DexCom Seven Plus Continuous Glucose Monitoring (CGM) device that...
What is the current status of trial NCT01271023?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2011-03. Estimated completion is 2012-08.
What conditions does trial NCT01271023 study?
This clinical trial studies the following conditions: Type 1 Diabetes.
What interventions are being tested in trial NCT01271023?
The interventions under investigation include: Control-to-Range Automated Insulin Management System (DEVICE).
Who is sponsoring clinical trial NCT01271023?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01271023 being conducted?
This trial has 7 study locations across California, Colorado, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01271023's enrollment target sits among peer trials
57 85th of 198 higher than 114 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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