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NCT01697150 · ClinicalTrials.gov registry record · NA
Outpatient Control-to-Range: System and Monitoring Testing
A NA study, sponsored by Sansum Diabetes Research Institute.
- Completed
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT01697150: Completed NA study, sponsored by Sansum Diabetes Research Institute.
NCT01697150 is a NA study that has completed, run by Sansum Diabetes Research Institute. The registered enrollment target is 5 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01697150, a NA study, has completed, sponsored by Sansum Diabetes Research Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
Study Summary
Automated closed-loop control (CLC) of blood glucose, known as "artificial pancreas" (AP) can have tremendous impact on the health and lives of people with type 1 diabetes (T1DM). The investigators inter-institutional and international research team has been on the forefront of CLC developments since the beginning of the JDRF Artificial Pancreas initiative in 2006. Thus far, the investigators have conducted three closed-loop control clinical trials (totaling 60 subjects with T1DM), which demonstrated significantly more time in an acceptable "target" blood glucose range during CLC, and significantly fewer hypoglycemic events during CLC compared to open loop. The investigators overall objective is to sequentially test, validate, obtain regulatory approval for, and deploy at home, a closed-loop Control-to-Range (CTR) system comprised of two algorithmic components: a Safety Supervision Module (SSM) and a Hypoglycemia Mitigation Module (HMM). The SSM will monitor the safety of the subject's continuous subcutaneous insulin infusion pump (CSII) to prevent hypoglycemia and will also monitor the integrity of continuous glucose monitor (CGM) data for signal sensor deviations or loss of sensitivity. The HMM will be responsible for the optimal regulation of postprandial hyperglycemic excursions through correction boluses. This study will test the ability of AP Platform to (1) run CTR in an outpatient setting, and (2) be remotely monitored. Specifically, this study involves studying adults with T1DM who are experienced insulin pump users. Subjects will spend two nights (-42 hours) in a local hotel, during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur. During the study, study subject will be responsible for. operating the CTR system with nursing and technicians available
Primary Outcome
The main endpoint will be the percent time with all expected data from CGM, pump and patient manual inputs that should be available on Artificial Pancreas platform and monitoring stations. To be considered as successful, this percent time will have to reach more than 80% of total time of investigation.
Interventions
- DEVICE DiAs Diabetes Assistant Wearable Artificial Pancreas Platform
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2012-04 |
| Est. Completion | 2015-12 |
| Phase | NA |
What the finished NCT01697150 record still lists
NCT01697150 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which DiAs Diabetes Assistant Wearable Artificial Pancreas Platform is the first listed.
NCT01697150 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01697150 about?
NCT01697150 is a clinical study titled "Outpatient Control-to-Range: System and Monitoring Testing". Automated closed-loop control (CLC) of blood glucose, known as "artificial pancreas" (AP) can have tremendous impact on the health and lives of people with type 1 diabetes (T1DM). The investigators inter-institutional and international research team has been on the forefront of CLC developments sinc...
What is the current status of trial NCT01697150?
This trial is currently completed. It is a NA study. The enrollment target is 5 participants. The study started on 2012-04. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01697150?
The interventions under investigation include: DiAs Diabetes Assistant Wearable Artificial Pancreas Platform (DEVICE).
Who is sponsoring clinical trial NCT01697150?
This trial is sponsored by Sansum Diabetes Research Institute, which has 33 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01697150's enrollment target sits among peer trials
5 1988th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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