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

Metabolic Disease Clinical Trial

Official title: Development and Validation of Artificial Intelligence Models for Non-invasive Glycaemic Event Detection Using ECG in Type 1 Diabetics

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

The study volunteers will be asked to an attend an 'inpatient' facility for up to 36 hrs dedicated to advanced metabolic measurement (HMRU). They will be asked to consume prepared meals of varying macronutrient content as part of a balanced diet, and performed prescribed physical activity. During this time the volunteers will be measured by instrumentation which will investigate the chemical concentration in respired gases (e.g. whole-body calorimeters, metabolic carts); bloods, saliva and urine samples will be taken. If the participant then wishes, we will ask them to continue to wear the wearable devices in a home setting for a maximum one week.

The data derived from this study will allow new tools and mathematical models to be developed that can be used to analyse and simulate patient metabolic response. It is envisaged this study will give further evidence to support future research into glucose utilisation in diseased metabolic populations. ;

Related Conditions & MeSH terms

• Metabolic Disease
• Metabolic Diseases

• NCT number: NCT05461144
• Study type: Observational
• Source: University Hospitals Coventry and Warwickshire NHS Trust
• Contact: John G Hattersley, PhD
• Phone: +44 (0) 24 7696 6068
• Email: john.hattersley@uhcw.nhs.uk
• Status: Not yet recruiting
• Start date: September 30, 2022
• Completion date: May 1, 2027