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.
None
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
The population will be recruited from the Warwickshire Institute for the study of diabetes, Endocrinology and Metabolism, at the University Hospitals Coventry and Warwickshire. WISDEM is a flagship partnership between the hospitals and the University of Warwick Medical School created to tackle diabetes and related metabolic conditions.
Cohort
Prospective
Not listed
Interstitial Glucose
As measured by a continuous glucose monitor \[NOTE\] Observational study thus a key measurement not a true outcome measure.
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.
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.
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)
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.
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University Hospitals Coventry and Warwickshire NHS Trust
Lead sponsor
University of Warwick
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
