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NCT01472406 · ClinicalTrials.gov registry record · Early Phase 1
Feasibility Study Using Zone-MPC Controller (Zone-Model Predictive Control) and Health Monitoring System (HMS)
A Early Phase 1 study, sponsored by Sansum Diabetes Research Institute.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
NCT01472406: Completed Early Phase 1 study, sponsored by Sansum Diabetes Research Institute.
NCT01472406 is a Early Phase 1 study that has completed, run by Sansum Diabetes Research Institute. The registered enrollment target is 12 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01472406, a Early Phase 1 study, has completed, sponsored by Sansum Diabetes Research Institute.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This clinical trial is a feasibility study to assess the performance of an Artificial Pancreas (AP) device using the Artificial Pancreas System (APS©) platform for subjects with type 1 diabetes. The device is a closed-loop between a DexCom™ SEVEN® PLUS (DexCom™ Corp, San Diego, CA) continuous glucose monitor (CGM) and a OneTouch® Ping® Glucose Monitoring System (Animas Corp, Westchester, PA) subcutaneous insulin delivery pump (CSII). The AP device is controlled by a zone-Model Predictive Control (zone-MPC) algorithm augmented by a safety algorithm named the Health Monitoring System (HMS). The clinical study will include 12 to 20 adults subjects aged 21 to 65 years old.
Primary Outcome
Measures ability of AP device to maintain glucose level within a safe zone and to return to save zone following unannounced meals and exercises.
Interventions
- DEVICE Continuous Glucose Monitor
- DEVICE Sansum Closed-Loop Artificial Pancreas
- DEVICE Insulin infusion pump
- DEVICE zone-Model Predictive Control algorithm
- DEVICE Safety Health Monitoring System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2011-11 |
| Est. Completion | 2014-03 |
| Phase | Early Phase 1 |
What the finished NCT01472406 record still lists
NCT01472406 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 5 interventions - of which Continuous Glucose Monitor is the first listed.
NCT01472406 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01472406 about?
NCT01472406 is a clinical study titled "Feasibility Study Using Zone-MPC Controller (Zone-Model Predictive Control) and Health Monitoring System (HMS)". This clinical trial is a feasibility study to assess the performance of an Artificial Pancreas (AP) device using the Artificial Pancreas System (APS©) platform for subjects with type 1 diabetes. The device is a closed-loop between a DexCom™ SEVEN® PLUS (DexCom™ Corp, San Diego, CA) continuous glucos...
What is the current status of trial NCT01472406?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2011-11. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01472406?
The interventions under investigation include: Continuous Glucose Monitor (DEVICE), Sansum Closed-Loop Artificial Pancreas (DEVICE), Insulin infusion pump (DEVICE), zone-Model Predictive Control algorithm (DEVICE), Safety Health Monitoring System (DEVICE).
Who is sponsoring clinical trial NCT01472406?
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 NCT01472406's enrollment target sits among peer trials
12 1530th of 2000 higher than 401 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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