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Type 2 DiabetesNCT05482958

DECIDE-CV Using AI

An observational study of Type 2 Diabetes, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes
What is being tested?
HOP watch
Type of treatment
Medical device
How many people
210 participants
Where
1 siteCanada
Study dates
29 Jul 2022to 29 Sep 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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)

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • McGill University health Center

    Montreal, Quebec, H4A 3J1

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Conditions
Type 2 Diabetes
Being tested
HOP watch
Keywords
Type 2 diabetes, Artificial intelligence, Wearable technology, Cardiovascular complications, Digital biomarker
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HOP watchDevice

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

Study groups in NCT05482958
Study groupRoleWhat they receive
Control: Participants without T2DMParticipants 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.
Receives: Device: HOP watch
Case: Patients with T2DMParticipants 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.
Receives: Device: HOP watch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presence or absence of T2DM

    As defined by HbA1c > 6.5 %, known history of T2DM, or on antihyperglycemic therapies

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

  2. Glycemic control amongst people with established T2DM.

    As defined by HbA1c %

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

Secondary outcomes (2)

  1. 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%

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

  2. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2022
  2. Study start29 Jul 2022
  3. Primary completion15 Sep 2025
  4. Study completion29 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
210 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05482958
Sponsor's protocol ID
2022-8286
Status last verified
Dec 2025
First submitted
26 Jul 2022
Last updated
17 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence or absence of T2DM (time frame: Cross sectional based on a single clinic visit with device worn for an estimated 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05482958.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.

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