NCT05482958

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

July 29, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2025

Completed
Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

3.1 years

First QC Date

July 26, 2022

Last Update Submit

December 9, 2025

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetesArtificial intelligenceWearable technologyCardiovascular complicationsDigital biomarker

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Glycemic control.

    Cross sectional based on a single clinic visit with device worn for an estimated 24 hours

  • Change in glycemic control.

    On average the change will be evaluated over 3-6 months

Study Arms (2)

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

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

Interventions

HOP watchDEVICE

A multisensor smartwatch that includes neurophysiological sensors such as heart rate sensor to monitor the vitals of the participant.

Case: Patients with T2DMControl: Participants without T2DM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University health Center

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Abhinav Sharma

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 26, 2022

First Posted

August 1, 2022

Study Start

July 29, 2022

Primary Completion

September 15, 2025

Study Completion

September 29, 2025

Last Updated

December 17, 2025

Record last verified: 2025-12

Locations

CA(1)