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NCT04498819: STAND-VAT

Wearable Technology and a Virtual Lifestyle Program for Type 2 Diabetics

Completed NA Last updated 6 October 2021
What this trial tests

NA trial testing Wearable Activity Trackers, Exercise Prescription and Virtual Care in Type 2 Diabetes in 10 participants. Completed in 7 May 2021.

Timeline
9 November 2020
Primary endpoint
2 April 2021
7 May 2021

Quick facts

Lead sponsorWestern University, Canada
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposehealth services research
Enrollment10
Start date9 November 2020
Primary completion2 April 2021
Estimated completion7 May 2021
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

Western University, Canada

Who can join

18 and older, any sex, with Type 2 Diabetes or Comorbidities and Coexisting Conditions. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The Primary Care Diabetes Support Program (PCDSP) offers a lifestyle medicine program, STAND, that patients can self-select themselves to participate. STAND offers biweekly, one-hour educational classes. With the onset of COVID-19, the clinic has moved virtually, but has yet to offer an individualized exercise program. Little evidence is available on utilizing telemedicine and wearable technologies combined in a clinical exercise setting. This is a 6-week single cohort prospective study assessing the feasibility of incorporating wearable activity trackers and individualized exercise prescriptions in the PCDSP's virtually delivered, STAND program in an adult population with type 2 diabetes mellitus. Roughly 15-20 participants will be recruited. Participants will attend the bi-weekly STAND classes and track their step counts daily using FitBits, trying to achieve individually prescribed step counts. Participants receive a brief follow up phone call every other week. The primary outcomes assessed will be recruitment and retention rates, as well as acceptability of, and adherence to, the virtual program. Acceptability will be assessed by an exit survey and mean number of reported technological issues. Adherence will be number of classes attended and percent of days with FitBit worn (\>500 steps) and average percent Libre sensor is active. Change in self-efficacy levels, diabetes emotional related distress, exercise volume, glucose control and fitness levels will secondarily be assessed.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Examining a Remote Group-Based Type 2 Diabetes Self-Management Education Program in the COVID-19 Era Using the ORBIT Model: Small 6-Week Feasibility Study.
    Hiemstra MS, Reichert SM, Mitchell MS. · · 2024 · PMID 38285502 · DOI 10.2196/46418

Verify or expand the search:

Other recruiting trials for Type 2 Diabetes

Currently open trials in the same condition.

Other Western University, Canada trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT04498819.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing