DECIDE-CV Using AI

McGill University

Status: Enrolling

Conditions: Type 2 Diabetes

Treatments: Device: HOP watch

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05482958

2022-8286

Details and patient eligibility

About

The purpose of this study is to identify digital biomarkers associated with type 2 diabetes mellitus (T2DM) by combining sensor data from a wrist-worn wearable and clinical data. This will be done by recruiting patients with and without diabetes within the cardio-metabolic clinics a the MUHC. Consented patients will be provided with a HOP Technologies (HOP) watch in this project across two observation periods. The Watch-HOP platform facilitates the development of predictive algorithms built with data collected in a clinical setting or at home in a passive (sensors) and active (self-assessments) way. Data from the Watch-Hop will be analyzed using machine learning strategies to determine associations with clinical measures of T2DM.

Full description

The epidemic of type 2 diabetes mellitus (T2DM) continues to increase. Sensor technologies and artificial intelligence present us with an opportunity to identify patients suffering from T2DM and to optimize their treatment.

Specifically, our primary objective is to identify digital biomarkers associated with T2DM by combining sensor data from a wrist-worn wearable and clinical data.

Enrollment: 126 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age > 18 years
2. Able to follow-up with study protocol schedule
3. Life expectancy > 1 year
4. Case group only a. HbA1c >= 6.5% or is diagnosed with T2DM

Exclusion criteria

1. Age > 18 years
2. Able to follow-up with study protocol schedule
3. Life expectancy > 1 year
4. Case group only a. HbA1c >= 6.5% or is diagnosed with T2DM

Trial design

126 participants in 2 patient groups

Control: Participants without T2DM

Description:

Participants without T2DM will be recruited and consented through the Courtois Cardiovascular Signature Biorepository protocol, HbA1c % will be measured at baseline from the stored bio-samples collected as a part of the biorepository program. A wearable will be worn for the duration of the clinic appointment. The participant will then wear the HOP watch for the designated period of time.

Treatment:

Device: HOP watch

Case: Patients with T2DM

Description:

Participants with T2DM, their baseline history of T2DM will be determined from chart review and patient history. In patients with T2DM, for the HbA1c % both at baseline and follow-up, the investigators will measure this value as a part of routine standard of care in the DECIDE-CV clinic. A subset of 20 participants will be given a Polar H10 chest-strap to be worn during the clinic. Participants will be given a HOP watch to wear in the clinical environment and will be discharged from the clinic to wear the watch for the designated period. Participants will subsequently wear the watch again, in 3-6 months for the designated period of time.

Treatment:

Device: HOP watch