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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Metabolic Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The study will be open to all individuals living independently, over 18 years without acute illness or ongoing clinical investigation, or volunteers with a stable medical condition may be included. Volunteers with an ongoing medical condition will only be included after detailed consultation with our clinical and dietetics members of the team; however, it is imperative that volunteers are able to provide written informed consent. Exclusion Criteria: Whilst the study employs a deliberately open inclusion criterion, the following exclusion measures will be employed: Children (under 18 yrs) Any adult who lacks decisional capacity Claustrophobia, isolophobia, recent abnormal exercise, radiation exposure within the preceding 24 hours of entering the whole-body calorimeter and feeling unwell in any way. Needle phobia Any medical/endocrine problem that could affect energy expenditure (e.g. thyroid problems, Cushing's syndrome) Chronic inflammatory disorders like rheumatoid arthritis, or long term use of steroids or other immunomodulators like cyclosporine, azathioprine. Beta blockers Currently actively losing weight Depression or any psychiatric illness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type1diabetes patients<br>Males and females diagnosed with T1D, aged over 18 years old who are currently under the care of the Warwickshire Institute for the Study of Diabetes, Endocrinolgy and Metabolism (WISDEM) at the University Hospitals Coventry and Warwickshire. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interstitial Glucose | As measured by a continuous glucose monitor [NOTE] Observational study thus a key measurement not a true outcome measure. | For the duration of the study, up to 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECG -Interval across different fiducial points | As measured by an ambulatory ECG device [NOTE] Observational study thus a key measurement not a true outcome measure. The interval across different fiducial points (P.Q.R,S,T) is one of the features that are useful to quantify the difference in ECG signals for different glycaemic events. | For the duration of the study, up to 5 days | 
| ECG - Slope across different fiducial points | As measured by an ambulatory ECG device [NOTE] Observational study thus a key measurement not a true outcome measure. The Slope across different fiducial points (P.Q.R,S,T) is one of the features that are useful to quantify the difference in ECG signals for different glycaemic events. | For the duration of the study, up to 5 days | 
| ECG - Indices of Heart Rate Variability | As measured by an ambulatory ECG device [NOTE] Observational study thus a key measurement not a true outcome measure. Heart rate variability (HRV) is the fluctuation in the time intervals between adjacent heartbeats. There are several indices that are useful to quantify the difference in ECG signals for different glycaemic events such as Ultra Low Frequency (ULF) (≤0.003 Hz), Very Low Frequency (VLF) (0.0033-0.04 Hz), Low Frequency (LF) (0.04-0.15 Hz) and High Frequency (HF) (0.15-0.4 Hz) | For the duration of the study, up to 5 days | 
| Blood Pressure (Systolic and Diastolic) | As measured by an ambulatory blood pressure device [NOTE] Observational study thus a key measurement not a true outcome measure. | For the duration of the study, up to 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endochrine