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NCT01871870 · ClinicalTrials.gov registry record · Phase 2
Artificial Pancreas Control System in an Outpatient Setting
A Phase 2 study, sponsored by Legacy Health System.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT01871870 is a Phase 2 study that has completed, run by Legacy Health System. The registered enrollment target is 20 participants.
The verdict
NCT01871870, a Phase 2 study, has completed, sponsored by Legacy Health System.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
The objectives of this outpatient research study are (1) to assess the ability of this automated system to be operated by a subject with limited professional oversight; (2) to assess whether the new devices (Dexcom Gen 4 sensors, Motorola ES400 smart phone, iDex pump controller) will reduce the frequency of hardware and data communication lapses seen in the previous system; and (3) to measure the degree of glucose control achievable with this automated system. The system will adjust blood glucose by administering insulin and glucagon. Insulin is a hormone that lowers blood glucose and will be given nearly continuously during this study. Glucagon raises blood glucose and will be automatically administered during hypoglycemia. Both are natural hormones made by people without diabetes. Each subject will have four devices placed on his abdomen: two Omnipod insulin pumps, one for delivering insulin and one for delivering glucagon, and two Dexcom G4 glucose sensors for measuring glucose. The two sensors will feed glucose data into Motorola smart phone master controller, which will calculate the correct amount of insulin or glucagon to deliver. The system will then send the command to the correct Omnipod through the iDex pod controller. In this new system, the research subject will be able to monitor the progress of the study by use of the smart phone graphical user interface. The subject will have a companion with him/her during the entire study for safety purposes. Both the subject and companion will complete a training course on how to treat diabetic emergencies and how to operate the system. A study physician and technician will be in the hotel during each study and will be monitoring the study via a cloud-based data communication system. These studies will be carried out in a hotel setting.
Interventions
- DEVICE Artificial Pancreas Control Software
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2013-05 |
| Est. Completion | 2013-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01871870
The ClinicalTrials.gov registry entry for NCT01871870 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Legacy Health System, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Artificial Pancreas Control Software is the first listed.
NCT01871870 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01871870 about?
NCT01871870 is a clinical study titled "Artificial Pancreas Control System in an Outpatient Setting". The objectives of this outpatient research study are (1) to assess the ability of this automated system to be operated by a subject with limited professional oversight; (2) to assess whether the new devices (Dexcom Gen 4 sensors, Motorola ES400 smart phone, iDex pump controller) will reduce the freq...
What is the current status of trial NCT01871870?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2013-05. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01871870?
The interventions under investigation include: Artificial Pancreas Control Software (DEVICE).
Who is sponsoring clinical trial NCT01871870?
This trial is sponsored by Legacy Health System, which has 21 total clinical trials registered on ClinicalTrials.gov.
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