DECIDE-CV Using AI

Montreal, Canada

N/A

Recruiting

Led By Abhinav Sharma

Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up on average the change will be evaluated over 3-6 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Eligible Conditions

Type 2 Diabetes

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ on average the change will be evaluated over 3-6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~on average the change will be evaluated over 3-6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and on average the change will be evaluated over 3-6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Glycemic control amongst people with established T2DM.

Presence or absence of T2DM

Secondary study objectives

Change in glycemic control.

Glycemic control.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Control: Participants without T2DMExperimental Treatment1 Intervention

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.

Group II: Case: Patients with T2DMExperimental Treatment1 Intervention

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.

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