Fever Tracking Study

Fever Tracking Study: The Feasibility of Fever Tracking in a Home-setting by a Non-invasive Wearable Core Body Temperature Sensor

The aim of this study is to investigate the feasibility of continuous fever tracking of participants having fever symptoms in a home setting, using a core body temperature (CBT) sensor. CBT as measured by the wearable sensors will be coampared with CBT as measured by ingestible electronc pills (reference).

A secondary research question is, if the CBT behavior of the the participants in a home setting can be compared to previously described CBT profiles in the literature, and if special patterns can be identified.

Study Overview

• Status: Completed
• Conditions: Core Body Temperature in Healthy Subjects; Immune Response to mRNA COVID-19 Vaccination

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• Switzerland
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4031
      • Universitiy Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects testing for COVID-19 at the University Hospital Basel and having acute fever symptoms, or individuals receiving the second shot or the booster of an mRNA COVID 19 vaccination, will be informed about the possibility to participate in this study by study personnel on-site.

Description

Inclusion Criteria:

• Age 18-60 years old
• Informed consent signed
• Either:

Acute fever symptoms at inclusion (at least 38.0°C) and Test for COVID-19 at the day of inclusion

- Or: Second shot or booster of mRNA COVD-19 vaccination (Comirnaty® or COVID-19 Vaccine Moderna®) at day of inclusion

Exclusion Criteria:

• Any participant who, for any reason, is unable to independently consent to participate in the study and/or who is unable to independently follow the study protocol.
• Any participant with previous surgical procedures in the gastrointestinal tract
• Inability to swallow pills
• Any participant of ≤40 kg body weight
• A scheduled MRI examination in the period from the start of the measurements until seven days after ingestion of the electronic pill.
• Any participant being pregnant

• Impairment or disability of the upper extremity likely to have a negative impact on the quality of measurements:

  • Wounds
  • Active venous access
  • Amputations
  • Dialysis shunt
  • Edema
  • Axillary dissection
  • Continuous long-term monitoring of blood pressure
  • Tattoos
• Known allergy to plastics / latex
• Language problems

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean absolute error, bias and standard deviation of the predicted CBT by the wearable CBT sensor compared to the reference temperature method (ingestible electronic pill)	This comparison will be done for each position of the wearable CBT sensor (apical, upper arm and wrist).	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean absolute error, mean bias and standard deviation of the predicted CBT sensor compared to the reference temperature method (ingestible electronic pill).	In addition to the primary outcome measure, the heartrate will be used as additional input to perform the CBT prediction of the wearables.	48 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influence of age on the predicted CBT	Age measured in years	48 hours
Influence of sex on the predicted CBT		48 hours
Influence of weight on the predicted CBT	Weight measured in kg	48 hours
Influence of height on the predicten CBT	Height measured in cm	48 hours
Influence of skin colour on the predicted CBT	Skin colour measured on the Fitzpatrick Skin Type Scala which classifies skin types from I to VI, depending on the amount of melanin pigment. Type I contains the lowest level of melanin, whereas type VI has the highest level.	48 hours
Influence of hairiness on the predicted CBT	Degree of hairiness expressed as mild, moderate and strong	48 hours
Influence of food intake on the predicted CBT	The impact of the above mentioned factor on the CBT will be monitored and recorded in a participant diary	48 hours
Influence of concomitant medications on the predicted CBT	The impact of the above mentioned factors on the CBT will be monitored and recorded in a participant diary	48 hours

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: greenTEG AG
• Investigators: Principal Investigator: Jens Eckstein, Prof. Dr., University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2021
• Primary Completion (Actual): March 3, 2022
• Study Completion (Actual): March 5, 2022

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: July 25, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Wearable sensors; Wearables; Fever Tracking; Core body temperature CBT; mRNA COVID-19 vaccination
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Fever Tracking

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No