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NCT Number: NCT05461144

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.

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Key information

Conditions

Metabolic Disease Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Interstitial Glucose

    Time frame: For the duration of the study, up to 5 days

    As measured by a continuous glucose monitor [NOTE] Observational study thus a key measurement not a true outcome measure.

Secondary outcomes

  1. ECG -Interval across different fiducial points

    Time frame: For the duration of the study, up to 5 days

    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.

  2. ECG - Slope across different fiducial points

    Time frame: For the duration of the study, up to 5 days

    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.

  3. ECG - Indices of Heart Rate Variability

    Time frame: For the duration of the study, up to 5 days

    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)

  4. Blood Pressure (Systolic and Diastolic)

    Time frame: For the duration of the study, up to 5 days

    As measured by an ambulatory blood pressure device [NOTE] Observational study thus a key measurement not a true outcome measure.

Study contacts

Contact information is provided by the study sponsor or research team.

John G Hattersley, PhD

CONTACT

[email protected]

+44 (0) 24 7696 6068

Leandro Pechhia, PhD

CONTACT

[email protected]

+44 (0) 24 7657 3383

Sponsors and collaborators

Lead sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Other

Collaborators

  • University of Warwick

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jul 15, 2022
Registry last updated
Jul 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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