DECIDE-CV Using AI

Delivering Evidence Based Care Using Artificial Intelligence to Patients With Diabetes and CardioVascular Comorbidities: The DECIDE-CV Innovation Project

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Device: HOP watch

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 210

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The investigators will recruit participants with T2DM (case group; n=90) and without T2DM (control group; n=120), calculated as per the method for sufficient statistical classification power (Protocol v4.0)

Description

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. Any person who does not meet the above criteria or who refuses to participate
2. Undergoing chemotherapy or dialysis
3. Currently in palliative care
4. Any person who does not have an email address
5. Control group only a. HbA1c >= 6.5% or is diagnosed with T2DM

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control: Participants without T2DM; 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.	Device: HOP watch; A multisensor smartwatch that includes neurophysiological sensors such as heart rate sensor to monitor the vitals of the participant.
Case: Patients with T2DM; 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.	Device: HOP watch; A multisensor smartwatch that includes neurophysiological sensors such as heart rate sensor to monitor the vitals of the participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence or absence of T2DM	As defined by HbA1c > 6.5 %, known history of T2DM, or on antihyperglycemic therapies	Cross sectional based on a single clinic visit with device worn for an estimated 24 hours
Glycemic control amongst people with established T2DM.	As defined by HbA1c %	Cross sectional based on a single clinic visit with device worn for an estimated 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic control.	Whether the digital biomarker as identified by the wrist-worn device differs between participants who have T2DM with glycemic control while using antihyperglycemic medications versus participants who do not have T2DM with baseline HbA1c < 6.5%. Glycemic control is defined as HbA1c < 6.5%	Cross sectional based on a single clinic visit with device worn for an estimated 24 hours
Change in glycemic control.	Whether changes provided by the digital biomarker also correlate with changes in HbA1c after initiation of antihyperglycemic treatments in the same participant over time. Change in glycemic control as measured by HbA1c % with specific antihyperglycemic medication	On average the change will be evaluated over 3-6 months

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborators: Boehringer Ingelheim; MedTeq; HOP-Child Technologies Inc
• Investigators: Principal Investigator: Abhinav Sharma, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2022
• Primary Completion (Actual): September 15, 2025
• Study Completion (Actual): September 29, 2025

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Estimated): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Type 2 diabetes; Artificial intelligence; Cardiovascular complications; Wearable technology; Digital biomarker
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2022-8286

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No