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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 is a Early Phase 1 study that has completed, run by Sansum Diabetes Research Institute. The registered enrollment target is 12 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01472406
The ClinicalTrials.gov registry entry for NCT01472406 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 12 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 5 interventions - of which Continuous Glucose Monitor is the first listed.
NCT01472406 reports 0 study locations.
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.
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