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Completed

NCT Number: NCT05482958

DECIDE-CV Using AI

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

McGill University health Center

Montreal, Quebec, H4A 3J1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

HOP watch

Device

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

Primary outcomes

  1. Presence or absence of T2DM

    Time frame: 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

  2. Glycemic control amongst people with established T2DM.

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

    As defined by HbA1c %

Secondary outcomes

  1. Glycemic control.

    Time frame: 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%

  2. Change in glycemic control.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Boehringer Ingelheim
  • HOP-Child Technologies Inc
  • MedTeq

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 1, 2022
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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