Skip to main content
Clinical Trials/NCT05482958
NCT05482958
Completed
Not Applicable

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

McGill University Health Centre/Research Institute of the McGill University Health Centre1 site in 1 country210 target enrollmentJuly 29, 2022
ConditionsType 2 Diabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Enrollment
210
Locations
1
Primary Endpoint
Presence or absence of T2DM
Status
Completed
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 29, 2022
End Date
September 29, 2025
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Responsible Party
Principal Investigator
Principal Investigator

Abhinav Sharma

Assistant Professor

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

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

  • 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 Sites (1)

Loading locations...

Similar Trials