Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a NA study that has completed, run by Sansum Diabetes Research Institute. The registered enrollment target is 5 participants.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01697150
The ClinicalTrials.gov registry entry for NCT01697150 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sansum Diabetes Research Institute, which has 33 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which DiAs Diabetes Assistant Wearable Artificial Pancreas Platform is the first listed.
NCT01697150 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.