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NCT01736930 · ClinicalTrials.gov registry record · Phase 2
An Outpatient Pump Shutoff Pilot Feasibility and Safety Study
A Phase 2 study of Type 1 Diabetes, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT01736930: Completed Phase 2 study of Type 1 Diabetes, sponsored by Jaeb Center for Health Research.
NCT01736930 is a Phase 2 study of Type 1 Diabetes that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 20 participants, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01736930, a Phase 2 study of Type 1 Diabetes, has completed, sponsored by Jaeb Center for Health Research.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to evaluate an overnight system that will turn off the insulin pump automatically if the system predicts that a low blood sugar is likely. 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. We have tested this system overnight in the hospital and are ready to test the system in the home environment to learn more about how well it will work and to make sure that the blood sugar does not go too high when the pump shuts off. This study has several phases and will take about a month or a little more for a patient to complete. Patients will use the study system for about 5 days at home to show that the patient is able to use it correctly. After that, the patient will be asked to use the study system each night for an additional 3-4 weeks. During this time, the system will be active for two-thirds of the nights and not active for one-third of the nights. When the system is active and predicts that your blood sugar will become low, the insulin pump will shut off for up to 2 hours. The study will include 2 clinical centers in the United States.
Primary Outcome
The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as mean morning blood glucose (mg/dL). An objective was to evaluate and refine the control algorithm. The data were reviewed periodically during the study with the pre-stated goal of determining whether any changes should be made in the control algorithm. Algorithm 1 was used for the first 105 nights of t
Conditions Studied
Interventions
- DEVICE Pump suspension
Study Locations (2)
California
- Stanford University - Stanford
Colorado
- Barbara Davis Center for Childhood Diabetes - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2012-01 |
| Est. Completion | 2012-06 |
| Phase | Phase 2 |
What the finished NCT01736930 record still lists
NCT01736930 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 1 intervention - of which Pump suspension is the first listed.
NCT01736930 reports a single indexed study location in California, Colorado.
Frequently Asked Questions
What is clinical trial NCT01736930 about?
NCT01736930 is a clinical study titled "An Outpatient Pump Shutoff Pilot Feasibility and Safety Study". The purpose of this study is to evaluate an overnight system that will turn off the insulin pump automatically if the system predicts that a low blood sugar is likely. The study system includes a combination continuous glucose monitor (CGM)/ insulin pump made by Medtronic MiniMed, Inc and a regular ...
What is the current status of trial NCT01736930?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2012-01. Estimated completion is 2012-06.
What conditions does trial NCT01736930 study?
This clinical trial studies the following conditions: Type 1 Diabetes.
What interventions are being tested in trial NCT01736930?
The interventions under investigation include: Pump suspension (DEVICE).
Who is sponsoring clinical trial NCT01736930?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01736930 being conducted?
This trial has 2 study locations across California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01736930's enrollment target sits among peer trials
20 152nd of 198 higher than 41 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes 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.
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