CORE NAUWKEURIGHEID

Als nieuwe technologie worden we vaak gevraagd door atleten, onderzoekers en media naar de nauwkeurigheid van CORE. Voor de lancering van de CORE is er ruim vijf jaar besteed aan onderzoek en ontwikkeling. Veel van de onderzoeken zijn gebaseerd op testen of gezamenlijke projecten met klinische onderzoekers en medische instellingen.

Op dit moment lopen er een reeks onafhankelijke onderzoeken met sportinstituten, medische instellingen en andere onderzoeksgroepen en zodra deze beschikbaar komen, zullen deze hier gedeeld worden.

CORE gebruikt athermische energieoverdracht sensor (niet huidtemperatuur). Tijdens onderzoeken valideren we de CORE met andere 'nauwkeurige' methoden, meestal de ingenomen e-pil, omdat deze het meest geschikt is voor sportieve activiteiten. Meer informatie over de wetenschappelijke gegevensvalidatie voor de nauwkeurigheid van de CORE, vind je hier.

Intern Testen

We blijven werken aan CORE-nauwkeurigheid en validatie in verschillende real-life omstandigheden. We maken gebruik van een grote verscheidenheid aan deelnemers die elk hun eigen unieke thermoregulatie reactie hebben. Bekijk hier een artikel over de testbenadering, gegevens verzameling en validatie voor de sport.

Hieronder vind je een overzicht van externe studies en projecten die nauwkeurigheid van de gegevens die CORE laat zien valideren onder verschillende omstandigheden.

External studies and projects

University of Trieste | A Novel Non-Invasive Thermometer for Continuous Core Body Temperature: Comparison with Tympanic Temperature in an Acute Stroke Clinical Setting

Ajčević, M., Buoite Stella, A., Furlanis, G., Caruso, P., Naccarato, M., Accardo, A., & Manganotti, P.
Link: https://pubmed.ncbi.nlm.nih.gov/35808257/

The CORE was validated in an independent clinical study led by Miloš Ajčević, Alex Stella and co-workers at the Cattinara University Hospital ASUGI in Trieste, Italy. The study was performed on 30 partially febrile stroke patients over 6 months.

The study showed a good agreement of the CORE with commonly used tympanic ear temperature measurements with no bias and a Limit of Agreement of: LoA 95% CI −0.55 – 0.77°C. The CORE measured effectively and accurately fever which is crucial for early detection of the deterioration of stroke patients. The detection was performed correctly in 94% of the cases. Hyperthermia and fever were defined respectively for temperatures above 37.5°C and 38.3°C

In addition, the researchers compared the CORE sensor to a forehead thermometer commonly employed for the observation of Stroke patients. The forehead thermometer shows a proportional bias of -0.388°C and a 95% LoA of−0.72 – 1.00°C with a trend of an overestimation of lower temperatures and an underestimation of higher temperatures.

The following graph represents the accuracy (LoA) of the CORE solution determined for this specific study in comparison with other clinical thermometers.

Figure 1 Accuracy (LoA) comparison of the CALERA® solution determined for this specific study in comparison with other clinical thermometers.

A Virtual Wearable Sensor for Detection of Neurodegenerative Diseases
Giovanni Schiboni, Martin Rerabek, and Krzysztof Kryszczuk, ZHAW (Wädenswil); PhilippEib, FabienRochat, Michele Zahner and Lukas Durrer, greenTEGAG (Zürich);Anneke Hertig-Godeschalk, David Schreier, Markus H. Schmidt, and JohannesMathis, Inselspital (Bern)

The thermal energy transfer sensor technology used in the CORE Body Temperature monitor is successfully being used in a Swiss based research project for early detection of Alzheimer and Parkinson diseases.
View Datasheet (PDF 910 KB)

Abstract: Alzheimer (AD), and Parkinson Diseases (PD) are reported to manifest themselves in changes to the circadian rhythm. A novel virtual wearable wrist-worn sensor, deployable in free living conditions, enables long-term predictive monitoring of the core body temperature, which is the only health marker directly linked to the circadian rhythm. The goal is to distinguish between normal and pathological core body temperature trajectories.

Wearable Medical Device for Remote Monitoring the Health of Elderly People at Home
Diego Barrettino1), 2), Thomas Gisler1), Christoph Zumbühl1), Christian Di Battista1), Raphael Kummer1) and Markus Thalmann1) 1) Lucerne University of Applied Sciences and Arts (HSLU)
View Datasheet (PDF 1.5 Mb)

Abstract: The design, fabrication and testing of a wearable medical device for remote monitoring the health of elderly people at home are presented in this paper. The proposed wearable medical device comprises a wide range of sensors, innovative sensor fusion algorithms and flexible electrodes that make possible to continuously run analyses such as hydration assessment, stress assessment, body temperature assessment, fall detection and heart monitoring. In-vivo measurement results showed the excellent performance of this wearable medical device in real-life scenarios.

Universitäres Schlaf-Wach-Epilepsie-Zentrum SWEZ
Dr. Krzysztof Kryszczuk, ZHAW

For this project completed in 2018, an early version of CORE was used at the INSEL hospital in a sleep study. Progress has been made since this study was published but even then the researchers were already satisfied with the results and could see the potential for this technology.
Visit Project Page: zhaw.ch

Project: Noninvasive core body temperature sensor for wearable sleep monitoring devices. The objective of the project was to create a proof of concept that it is feasible to estimate the core body temperature from the wearable sensors using the skin temperature and heat flux sensors. In the course of the project, a prototype of a standalone wearable sensor device was developed. The sensor is lightweight and allows for non-invasive continuous estimation of Core Body Temperature with an average error smaller than 0.4 centigrade, using the measurements of the skin temperature and thermal energy transfer sensor.

Additional ongoing public projects

University Hospital Zurich
Fever algorithm development of a non-invasive wearable core body temperature sensor system in intensive care unit patients

ClinicalTrials.gov Identifier: NCT04182945