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NCT03809858
Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses
NA trial testing Klue App in Diabetes Mellitus, Type 1 in 12 participants. Completed in 18 November 2019.
18 November 2019
Quick facts
| Lead sponsor | University of Virginia |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 12 |
| Start date | 29 May 2019 |
| Primary completion | 18 November 2019 |
| Estimated completion | 18 November 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Klue App
Conditions studied
- Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →
Sponsor
University of Virginia
Who can join
18 and older, any sex, with Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Smartwatch gesture-based meal reminders improve glycaemic control.
Corbett JP, Hsu L, Brown SA, Kollar L, et al · · 2022 · cited 22× · PMID 35491517 · DOI 10.1111/dom.14737
Verify or expand the search:
- PubMed search for NCT03809858
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03809858 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Virginia
- Last refreshed: 21 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03809858.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing