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NCT04328896 · ClinicalTrials.gov registry record · NA
Telemedicine Monitoring of Nocturnal Incidents
A NA study, sponsored by University of Southern California.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT04328896 is a NA study that has completed, run by University of Southern California. The registered enrollment target is 10 participants.
The verdict
NCT04328896, a NA study, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study Summary
Reducing hypoglycemia is an important aspect of management of type 1 diabetes (T1D) in older adults, many of whom have hypoglycemic unawareness, cognitive impairment, or both. Continuous Glucose Monitoring (CGM) offers the opportunity to reduce hypoglycemia and its related complications such as fractures from falls and hospitalizations and improve QOL including reducing hypoglycemic fear and diabetes distress. The potential benefit of CGM in reducing hypoglycemia in the older adult population has not been well studied. Prior and on-going trials compare CGM to self-monitoring of blood glucose levels, but none look at remote daily monitoring of CGM data or provision of telemedicine based on clinic notification of hypoglycemic events. This study is a 14 week, single center, pilot study of 10 subjects 65-75 yrs old with type 1 diabetes. The primary aim is to determine the effect of continuous remote CGM reporting coupled with a telemedicine intervention (Tele-CGM program) on rates of hypoglycemia in adults with T1D \>65 years old. Study staff will review Tidepool uploads and call/email to the patient if one of the following occur has occurred in the past 24 hours: ≥4 hours without CGM signal, ≥2 hours 54 - 70 mg/dl and/or 15 minutes \<54 mg/dl. Tele-monitoring call will include questions to find out why the event happened and then suggestions on how to trouble shoot to avoid issues in the future. As this is a feasibility study, statistical considerations were not used.
Interventions
- OTHER CGM-Tele-monitoring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-06-15 |
| Est. Completion | 2018-11-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04328896
The ClinicalTrials.gov registry entry for NCT04328896 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CGM-Tele-monitoring is the first listed.
NCT04328896 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04328896 about?
NCT04328896 is a clinical study titled "Telemedicine Monitoring of Nocturnal Incidents". Reducing hypoglycemia is an important aspect of management of type 1 diabetes (T1D) in older adults, many of whom have hypoglycemic unawareness, cognitive impairment, or both. Continuous Glucose Monitoring (CGM) offers the opportunity to reduce hypoglycemia and its related complications such as frac...
What is the current status of trial NCT04328896?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2018-06-15. Estimated completion is 2018-11-30.
What interventions are being tested in trial NCT04328896?
The interventions under investigation include: CGM-Tele-monitoring (OTHER).
Who is sponsoring clinical trial NCT04328896?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
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