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NCT00717977 · ClinicalTrials.gov registry record · Phase 4
Continuous Glucose Sensor Profiles in Non-Diabetic Subjects
A Phase 4 study, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- Phase 4
- Development phase
- 74
- Enrollment target
NCT00717977 is a Phase 4 study that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 74 participants.
The verdict
NCT00717977, a Phase 4 study, has completed, sponsored by Jaeb Center for Health Research.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 74 participants
- Enrollment target
Study Summary
The Juvenile Diabetes Research Foundation (JDRF) Glucose Sensor Study group is carrying out a large, randomized clinical trial to assess the efficacy, safety and cost-effectiveness of use of real-time continuous glucose monitors (RT-CGM) as an adjunct to standard meter plasma glucose testing. Although the primary outcome in the \>= 7.0% cohort is differences in HbA1c levels, important secondary outcomes are differences in the percent of glucose sensor values either above or below the target glucose range of 70-180 mg/dl and differences in glucose variability. Prevention of biochemical hypoglycemia is a particularly important outcome in the low HbA1c cohort. Since CGM systems measure interstitial rather than plasma glucose and CGM values differ from simultaneous plasma glucose values by up to 18%, it would be extremely useful for comparative purposes to establish a reference range of sensor values in healthy, non-diabetic control subjects for this study and other future investigations. The objective of this protocol is to establish such reference sensor glucose ranges in each of the 3 devices being utilized in the JDRF study.
Interventions
- DEVICE Continuous glucose monitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2008-07 |
| Est. Completion | 2009-03 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00717977
The ClinicalTrials.gov registry entry for NCT00717977 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 74 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 Continuous glucose monitor is the first listed.
NCT00717977 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00717977 about?
NCT00717977 is a clinical study titled "Continuous Glucose Sensor Profiles in Non-Diabetic Subjects". The Juvenile Diabetes Research Foundation (JDRF) Glucose Sensor Study group is carrying out a large, randomized clinical trial to assess the efficacy, safety and cost-effectiveness of use of real-time continuous glucose monitors (RT-CGM) as an adjunct to standard meter plasma glucose testing. Althou...
What is the current status of trial NCT00717977?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 74 participants. The study started on 2008-07. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00717977?
The interventions under investigation include: Continuous glucose monitor (DEVICE).
Who is sponsoring clinical trial NCT00717977?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
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