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NCT01591681 · ClinicalTrials.gov registry record · Phase 2
Outpatient Pump Shutoff Pilot Feasibility and Efficacy Study
A Phase 2 study, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
NCT01591681 is a Phase 2 study that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 49 participants.
The verdict
NCT01591681, a Phase 2 study, has completed, sponsored by Jaeb Center for Health Research.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
Study Summary
The purpose of this study is to see whether low blood sugar at night can be reduced by using a system that turns off the insulin pump automatically. The study system includes a combination continuous glucose monitor (CGM)/ insulin pump made by Medtronic MiniMed, Inc and a regular laptop computer that runs a computer program that predicts low blood sugar. It works by (1) measuring the glucose levels under the skin with a continuous glucose monitor, (2) using a computer program on a laptop to predict what will happen to the glucose level over the next 35-55 minutes, and (3) turning off the insulin pump when the computer program predicts that low blood sugar will occur. This study has several phases and will take about 3 months for a patient to complete. Patients will use the Medtronic CGM with the Enlite sensor at home for 10-15 days to be sure that they are able and willing to use this system and to determine if they meet the investigators study criteria to proceed with the next phase of the study. Patients will be provided teaching on how to use CGM data in real time. If a patient is not using a Medtronic CGM already, the patient will first use one at home for 10-15 days to be sure that he/she is able and willing to use it. If a patient is already using a Medtronic CGM, then his/her most recent 10-15 days of data will be used to find out if he/she is eligible. Those who need to complete the CGM run-in phase will have an extra office visit for training. If eligible to continue in the study, patients will need to use the study system for 5 nights at home so that the investigators can make sure they are able to use it correctly. After that, patients will be asked to use the study system each night for an additional 6 to 8 weeks. If the system is active and predicts that a patient's blood sugar will become low, the insulin pump will shut off for up to 2 hours. The study will include about 45 individuals at 3 clinical centers in the United States and Canada.
Interventions
- DEVICE Pump suspension
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2012-11 |
| Est. Completion | 2013-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01591681
The ClinicalTrials.gov registry entry for NCT01591681 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jaeb Center for Health Research, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pump suspension is the first listed.
NCT01591681 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01591681 about?
NCT01591681 is a clinical study titled "Outpatient Pump Shutoff Pilot Feasibility and Efficacy Study". The purpose of this study is to see whether low blood sugar at night can be reduced by using a system that turns off the insulin pump automatically. The study system includes a combination continuous glucose monitor (CGM)/ insulin pump made by Medtronic MiniMed, Inc and a regular laptop computer tha...
What is the current status of trial NCT01591681?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2012-11. Estimated completion is 2013-07.
What interventions are being tested in trial NCT01591681?
The interventions under investigation include: Pump suspension (DEVICE).
Who is sponsoring clinical trial NCT01591681?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
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