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NCT01823341 · ClinicalTrials.gov registry record · Phase 2
Outpatient Reduction of Nocturnal Hypoglycemia by Using Predictive Algorithms and Pump Suspension in Children
A Phase 2 study, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- Phase 2
- Development phase
- 97
- Enrollment target
NCT01823341 is a Phase 2 study that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 97 participants.
The verdict
NCT01823341, a Phase 2 study, has completed, sponsored by Jaeb Center for Health Research.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 97 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 continuous glucose monitor (CGM) and an insulin pump. The CGM and pump work with a regular laptop computer. A The system works by (1) measuring the glucose levels under the skin with the CGM, (2) using a computer program on the laptop to predict whether a low blood sugar is likely to occur, and (3) turning off the insulin pump when the computer program predicts that a low blood sugar will occur. We have tested the system in the home environment in individuals with type 1 diabetes age 15 years and older. We have found an indication that the system can decrease the frequency of hypoglycemia. We have not had any serious cases of high blood sugars or other problems. We are now ready to further test the system in the home environment in a younger age group to learn more about its ability to reduce overnight low blood sugar risk. This study has several phases and will take about 3 months for a patient to complete. * First, the patient will use the CGM and pump at home for up to 15 days with the help of a parent/guardian. This is done to determine if the patient meets our study criteria to proceed with the next phase of the study. * If the patient is eligible to continue in the study, the patient will need to use the full study system for at least 5 nights at home with the help of a parent/guardian. This is done to make sure the patient and parent/guardian are able to use the system correctly. The patient may participate in starting and stopping the system at home, but the parent/guardian is responsible for making sure it is used as instructed. * After that, the patient will be asked to use the study system each night for an additional 6 to 8 weeks. The parent/guardian will remain responsible for making sure the system is used as instructed. The study will include about 90 individuals with type
Interventions
- DEVICE Pump suspension algorithm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2013-05 |
| Est. Completion | 2014-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01823341
The ClinicalTrials.gov registry entry for NCT01823341 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 97 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 algorithm is the first listed.
NCT01823341 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01823341 about?
NCT01823341 is a clinical study titled "Outpatient Reduction of Nocturnal Hypoglycemia by Using Predictive Algorithms and Pump Suspension in Children". 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 continuous glucose monitor (CGM) and an insulin pump. The CGM and pump work with a regular laptop computer. A The system wo...
What is the current status of trial NCT01823341?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 97 participants. The study started on 2013-05. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01823341?
The interventions under investigation include: Pump suspension algorithm (DEVICE).
Who is sponsoring clinical trial NCT01823341?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
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