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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: Completed NA study, sponsored by University of Virginia.
NCT03809858 is a NA study that has completed, run by University of Virginia. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The change in the number of missed meal boluses
Interventions
- OTHER Klue App
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-05-29 |
| Est. Completion | 2019-11-18 |
| Phase | NA |
What the finished NCT03809858 record still lists
NCT03809858 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Klue App is the first listed.
NCT03809858 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03809858's enrollment target sits among peer trials
12 1913th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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