CompletedNot Applicable

Wearable Technology and a Virtual Lifestyle Program for Type 2 Diabetics

Canada10 participantsStarted 2020-11-09

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * a new patient intake at the PCDSP, * ≥18 years old, * ability to communicate in English, * diagnosis of T2D , * declared interest in participating in the STAND-VAT study, * interest in using wearable technology, * medically cleared to participate in exercise, * ownership of a smartphone and able to have Internet connection. The smartphone must be either iPhone 7 (with an iOS of 12.2 or higher) or Android operating system 5 or higher to allow for FitBit© and LibreView mobile application compatibility, * ownership of a laptop or desktop computer, * access to Internet connection. Exclusion Criteria: * Inability to participate in the full 6-week program, * active or recent (within 12-weeks) foot ulcer(s), * unstable blood pressure, * unstable blood sugars including recurrent hypo/hyperglycemia, * untreated retinopathy, * unstable cardiovascular disease (CVD), * pregnancy, * or unstable psychiatric disease limiting group participation.

What they're measuring

Feasibility: Recruitment

Timeframe: from the date of of the first participant recruited the last participant recruited for the study (estimated last date for recruitment cut off is November 14th, 2020; allowing for study data collection completion by December 18, 2020).

Feasibility: Retention

Timeframe: From time of consent and up to 9 weeks later (study completion)

Feasibility: Acceptability

Timeframe: Week 1 of intervention up to time of follow up (7 weeks later)

Feasibility: Adherence

Timeframe: Week 1 of intervention to week 6

Trial details

NCT IDNCT04498819

SponsorWestern University, Canada

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-04-02

View on ClinicalTrials.gov More Type 2 Diabetes trials