An innovative medical device for early diagnosis based on a disruptive body temperature monitoring and analysis scheme-t-Clinic

Project Information

t-Clinic

Grant agreement ID: 717286

DOI

10.3030/717286

Project closed

EC signature date 17 March 2016

Start date 1 April 2016

End date 30 September 2016

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

INNOVATEC SENSORIZACION Y COMUNICACION, S.L.
Spain

Periodic Reporting for period 1 - t-Clinic (An innovative medical device for early diagnosis based on a disruptive body temperature monitoring and analysis scheme-t-Clinic)

Reporting period: 2016-04-01 to 2016-09-30

Summary of the context and overall objectives of the project

Although body temperature is obviously a quantitative, continuous variable, in daily practice, it is always used as a qualitative, dichotomic variable (febrile ⁄ afebrile). Once fever has been confirmed, it is assumed that the patient is sick, but nothing can be said about the fever’s aetiology. Classic fever patterns have almost uniformly fallen in discredit and clinicians do not usually pay attention to temperature profiles. However, even in acute care settings, temperature time series are generally sampled at a very low frequency, at a single site and only conventional statistics are usually applied.
Continuous monitoring and analysis of central and peripheral temperature would detect the “building” of a fever, therefore allowing its forecast before it appears. Although temperature is a well known symptom of disease, its diagnostic power is currently very small. In some patients admitted to a hospital, a continuous reading of temperature may provide relevant information that may be overlooked by conventional care.
Innovatec has developed an advanced non-invasive body temperature monitor t-Clinic capable of long-term accurate thermoregulation assessment that can provide a low cost prompt diagnosis tool that will reduce the need for referrals, and will become an effective tool for body temperature dynamics correlation with disorder onset and progression.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The work performed from the beginning of the project is summarised as follows:
- Review and update of the state of the art in clinical thermometry.

- Demonstration and experimentation activities.

- Stakeholder analysis.

- Study the regulatory framework for t-Clinic.

- IPR protection study.

- Study of the unique selling points for t-Clinic.

- Competitors analysis.

- Barriers analysis.
- Pricing policy analysis.

- Financial analysis.

- Sources of financing analysis.

- Risk analysis.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

This t-Clinic project aims to achieve the following progress beyond the state of the art:
- It would be a big step in the overcoming of the anachronistic “febrile/afebrile” dichotomy and walking towards a “system medicine” approach to certain diseases.
- Increasing the sensitivity of blood cultures would be a major breakthrough, with important clinical consequences.
- Early detection of (oligosymptomatic) febrile episodes may suggest seeking early medical attention, which in certain cases has important clinical consequences.
The expected potential impacts are varied and diverse:
- Comprehensive project focusing on multiple aspects such as multiparameter data management, modelling, development of fever models that capture the complexity and diversity of thermoregulation in different diseases.
- Combine the existing knowledge of the underlying disease process with functional signalling data.
- Provide avenues for the development of new clinical procedures.
- Study how the thermoregulatory environment influences therapeutic response.
- Detect aggressive sepsis earlier when they are more easily treated.
- Discover robust therapeutic strategies faster and cheaper.
- Tailor treatments to individuals.
- Improved understanding of fever factors, new technological capabilities in modelling, diagnostic, and disease identification.
- New instrumentation to improve fever-related disease detection and management.
- Use new data sources and methods to improve global coverage, sensitivity, and timeliness.
- Measurable lasting changes in the behaviour and clinical practices, and in the coverage and quality of services of medical institutions. It can become standard of care.
- Predict how immune strategies can be boosted to work against pathogens.
- Help the medical community to address the inter-related causes of fever.
- Help in the ambulatory monitoring of patients at epidemiologic risk (e.g. contacts of infectious patients, etc.).

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