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NCT02137512 · ClinicalTrials.gov registry record · NA
Pilot Study 3 of Outpatient Control-to-Range: Safety and Efficacy With Day-and-Night In-Home Use
A NA study of Type 1 Diabetes, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 6
- Study locations
NCT02137512: Completed NA study of Type 1 Diabetes, sponsored by Jaeb Center for Health Research.
NCT02137512 is a NA study of Type 1 Diabetes that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 30 participants, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (96% lower). The trial reports 6 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02137512, a NA study of Type 1 Diabetes, has completed, sponsored by Jaeb Center for Health Research.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of this study is to see if an automated insulin management system ("study system") can safely be used at home to manage blood sugar. The study system includes (1) a CGM that measures glucose levels, (2) a computer program on a smartphone that determines how much insulin is needed and allows the study participant user to control the whole system, and (3) an insulin pump that delivers the insulin. The CGM will be from Dexcom. The pump will be from Roche. The CGM and pump are similar to the devices that are currently available for people to purchase and use. However, the smartphone device, the CGM sensor type used with it, and the overall study system can only be used for research at this time. The study will be completed by about 24 individuals at 6 centers in the United States and Europe. This study has several phases and will take about 11-14 weeks to complete depending on whether the study participant is a CGM user or not. At selected sites (based on subject eligibility and availability), approximately 10-20 subjects who exhibit safe and competent use of the system at home will be given the option to continue home use of the system in Day-and-Night Closed-Loop mode for up to 5 months.
Primary Outcome
Percentage of CGM Measured Glucose Values \<70 mg/dl during study Main Phase, night only (23:00 to 07:00)
Conditions Studied
Interventions
- DEVICE Closed-Loop Control System
- DEVICE Sensor-Augmented Pump (SAP)
Study Locations (6)
Other
- Montpellier University Hospital - Montpellier
- National Center for Childhood Diabetes- Schneider Children's Medical Center - Petah Tikva
- University of Padova - Padua
California
- Sansum Diabetes Research Institute - Santa Barbara
- Stanford University - Stanford
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2014-08 |
| Est. Completion | 2015-11 |
| Phase | NA |
What the finished NCT02137512 record still lists
NCT02137512 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Closed-Loop Control System is the first listed.
NCT02137512 lists 6 locations in 3 states (Other, California, Virginia).
Frequently Asked Questions
What is clinical trial NCT02137512 about?
NCT02137512 is a clinical study titled "Pilot Study 3 of Outpatient Control-to-Range: Safety and Efficacy With Day-and-Night In-Home Use". The purpose of this study is to see if an automated insulin management system ("study system") can safely be used at home to manage blood sugar. The study system includes (1) a CGM that measures glucose levels, (2) a computer program on a smartphone that determines how much insulin is needed and all...
What is the current status of trial NCT02137512?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2014-08. Estimated completion is 2015-11.
What conditions does trial NCT02137512 study?
This clinical trial studies the following conditions: Type 1 Diabetes.
What interventions are being tested in trial NCT02137512?
The interventions under investigation include: Closed-Loop Control System (DEVICE), Sensor-Augmented Pump (SAP) (DEVICE).
Who is sponsoring clinical trial NCT02137512?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02137512 being conducted?
This trial has 6 study locations across California, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02137512's enrollment target sits among peer trials
30 127th of 198 higher than 68 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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