Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
210 participants
OBSERVATIONAL
2022-07-29
2025-09-29
Brief Summary
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Detailed Description
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Specifically, our primary objective is to identify digital biomarkers associated with T2DM by combining sensor data from a wrist-worn wearable and clinical data.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
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.
HOP watch
A multisensor smartwatch that includes neurophysiological sensors such as heart rate sensor to monitor the vitals of the participant.
Interventions
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HOP watch
A multisensor smartwatch that includes neurophysiological sensors such as heart rate sensor to monitor the vitals of the participant.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
Yes
Sponsors
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HOP-Child Technologies Inc
UNKNOWN
MedTeq
INDUSTRY
Boehringer Ingelheim
INDUSTRY
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Responsible Party
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Abhinav Sharma
Assistant Professor
Principal Investigators
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Abhinav Sharma
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Locations
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McGill University health Center
Montreal, Quebec, Canada
Countries
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Other Identifiers
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2022-8286
Identifier Type: -
Identifier Source: org_study_id