DECIDE-CV Using AI

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05482958
• Other study ID #: 2022-8286
• Status: Recruiting
• Start date: July 29, 2022
• Est. completion date: July 29, 2025

Study information

• Verified date: August 2023
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Abhinav Sharma, MD
• Phone: 5149341934
• Email: abhinav.sharma[@]mcgill.ca
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: July 29, 2025
• Est. primary completion date: July 29, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age > 18 years

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:

1. Age > 18 years

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Device:
• HOP watch
Prospective observational study

Locations

Country	Name	City	State
Canada	McGill University health Center	Montreal	Quebec

Sponsors (4)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	Boehringer Ingelheim, HOP-Child Technologies Inc, MedTeq

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence or absence of T2DM	As defined by HbA1c > 6.5 %, known history of T2DM, or on antihyperglycemic therapies	Cross sectional based on a single clinic visit with device worn for an estimated 24 hours
Primary	Glycemic control amongst people with established T2DM.	As defined by HbA1c %	Cross sectional based on a single clinic visit with device worn for an estimated 24 hours
Secondary	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%	Cross sectional based on a single clinic visit with device worn for an estimated 24 hours
Secondary	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	On average the change will be evaluated over 3-6 months