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
NCT number | NCT05482958 |
Other study ID # | 2022-8286 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 29, 2022 |
Est. completion date | July 29, 2025 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | McGill University health Center | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University Health Centre/Research Institute of the McGill University Health Centre | Boehringer Ingelheim, HOP-Child Technologies Inc, MedTeq |
Canada,
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 |
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