AI Models for Non-invasive Glycaemic Event Detection Using ECG in Type 1 Diabetics

This observational study aims to recruit up to thirty T1DM patients from a diabetic outpatient clinic at the University Hospital Coventry and Warwickshire for a two-phase study. The first phase involves attending an inpatient protocol for up to thirty-six hours in a calorimetry room at the Human Metabolism Research Unit under controlled conditions, followed by a phase of free-living, for up to three days, in which participants will go about their normal daily activities without restriction. Throughout the study, the participants will wear commercially available wearable sensors to measure and record physiological signals (e.g., electrocardiogram and continuous glucose monitor). Data collected will be used to develop and validate an AI model using state-of-the-art deep-learning methods for the purpose of non-invasive glycaemic event detection.

NCT Number	NCT05461144
Lead Sponsor	University Hospitals Coventry and Warwickshire NHS Trust Collaborators: University of Warwick
Conditions	Metabolic Disease
Enrollment	30 participants
Start Date	2022-09-30
Primary Completion	2026-05-01 (estimated)
Study Completion	2027-05-01 (estimated)
Updated on ClinicalTrials.gov	2022-07-15