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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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