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NCT03809858 · ClinicalTrials.gov registry record · NA
Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses
A NA study, sponsored by University of Virginia.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT03809858 is a NA study that has completed, run by University of Virginia. The registered enrollment target is 12 participants.
The verdict
NCT03809858, a NA study, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study Summary
This will be a randomized, cross-over, unblinded study with subjects randomized upon entry into the study to either begin using the Klue software for 6 weeks or to continue with their usual care for 6 weeks. Subjects are eligible for enrollment if they are using a continuous glucose monitor (CGM) with an insulin pump or an insulin pen with memory, and are missing or late in giving at least 4 food boluses in the previous two weeks. Missing or late meal boluses will be assessed through their pump/pen and sensor downloads. This is a pilot study. There is no preliminary data to do a true power calculation. The primary outcome will be the change in the number of missed meal boluses in the two weeks prior to each visit. Secondary outcome measures will be the number of missed meal boluses in each month of the study, change in HbA1c levels (measured every 6 weeks), accuracy of the Klue software in detecting meals (true positive and false positive rates), and a user satisfaction survey.
Interventions
- OTHER Klue App
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-05-29 |
| Est. Completion | 2019-11-18 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03809858
The ClinicalTrials.gov registry entry for NCT03809858 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Klue App is the first listed.
NCT03809858 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03809858 about?
NCT03809858 is a clinical study titled "Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses". This will be a randomized, cross-over, unblinded study with subjects randomized upon entry into the study to either begin using the Klue software for 6 weeks or to continue with their usual care for 6 weeks. Subjects are eligible for enrollment if they are using a continuous glucose monitor (CGM) wi...
What is the current status of trial NCT03809858?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2019-05-29. Estimated completion is 2019-11-18.
What interventions are being tested in trial NCT03809858?
The interventions under investigation include: Klue App (OTHER).
Who is sponsoring clinical trial NCT03809858?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
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