Viewing Study NCT05482958


Ignite Creation Date: 2025-12-25 @ 12:10 AM
Ignite Modification Date: 2025-12-25 @ 10:11 PM
Study NCT ID: NCT05482958
Status: COMPLETED
Last Update Posted: 2025-12-17
First Post: 2022-07-26
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: DECIDE-CV Using AI
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Organization:

Study Overview

Official Title: Delivering Evidence Based Care Using Artificial Intelligence to Patients With Diabetes and CardioVascular Comorbidities: The DECIDE-CV Innovation Project
Status: COMPLETED
Status Verified Date: 2025-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: