DECIDE-CV Using AI

Recruiting

• Conditions: Type 2 Diabetes
• Interventions: Device: HOP watch

• Registration Number: NCT05482958
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief 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.

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 Timeline

• Study First Submitted: 2022-07-26
• Study First Submitted QC: 2022-07-28
• Study Start: 2022-07-29
• Study First Posted: 2022-08-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-07
• Primary Completion: 2025-07-29
• Study Completion: 2025-07-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control: Participants without T2DM	HOP watch	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.
Case: Patients with T2DM	HOP watch	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Glycemic control.	Cross sectional based on a single clinic visit with device worn for an estimated 24 hours	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%
Change in glycemic control.	On average the change will be evaluated over 3-6 months	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

Trial Locations

Locations (1)

McGill University health Center; 🇨🇦 Montreal, Quebec, Canada