Continuos Body Temperature Monitoring

November 3, 2026 updated by: Baby FM Doo

Examination of a Telemedicine System for Continuous Monitoring of Body Temperature in Adults - a Pilot Study

This is a nonrandomized, diagnostic, single-center, pilot study, with one group of participants. The aim is to examine the effectiveness and safety of telemedicine system for continuous measurement of body temperature in adults. Up to 40 subjects will participate in this phase of the clinical trial. No stratification, nor randomization of subjects will be performed. Respondents who meet the inclusion criteria will be monitored for up to 72 hours plus 72 hours after removing the device. Namely, the device will be placed on their body and will be there until upt to 72 hours, and then it will be removed. The respondent will be monitored by the team for an additional 72 hours by the person in charge of the examination, for possible side effects.

Sensor will be placed in the axilar joint or a little below on the side. The device will be connected to a mobile phone. Member of the research team (principal researcher/co-researcher/ nurse in charge of examination) measures the temperature of the skin in the opposite armpit manually, ie with a gallium thermometer and records every 30-60 minutes. When body temperature starts to rise, a member of the research team measures the body temperature every 15-30 minutes. After reaching a stable temperature, the temperature is measured every 30-60 minutes. If the subject is given drugs to lower body temperature, the temperature is measured again every 15-30 minutes until the temperature stabilizes to a normal subfebrile state.

Study Overview

Status

Completed

Conditions

Fever

Intervention / Treatment

Diagnostic test: Continous body temperature monitoring

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Serbia
- Other/Not Applicable
  - Belgrade, Other/Not Applicable, Serbia, 11000
    - University Clinical Center of Serbia, Clinic for Infectious and Tropical Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Up to 40 eligible participants with disease and/or condition that results in body temperature variation will be included in the study.

Description

Inclusion Criteria:

A person of male or female sex
Age 18 and over
Ability to measure the patient's body temperature frequently
People who are hospitalized due to any type of infection or any other diseases that result in variations in body temperature (rise, fall)
Completed all potential diagnostics of the hospitalized patient (no interrupting the measurement of the telemedicine device)

Exclusion Criteria:

Allergic to contact with plastic or silver
Anatomical anomalies that prevent the placement of the system
High-risk health conditions, intensive care and the like
A pacemaker or other device on the skin or implanted in the body that emits light electromagnetic radiation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: CASE_CONTROL
Time Perspectives: PROSPECTIVE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation Coefficient Time Frame: Up to 72 hours	The correlation between the Baby FM continuous temperature monitoring device and a reference standard gallium thermometer is expected to be high. The primary outcome was the correlation coefficient using all paired temperature measurements from the overall study population. Participant-level correlation coefficients were also calculated for individual participants. Higher correlation coefficients indicate a stronger linear association between measurements from the two devices.	Up to 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Device and Procedure Related Adverse Events Time Frame: Up to six days	The number and percentage of adverse events related to the investigational product will be evaluated and summarized.	Up to six days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baby FM Doo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2024

Primary Completion (Actual)

June 30, 2026

Study Completion (Actual)

June 30, 2026

Study Registration Dates

First Submitted

June 2, 2024

First Submitted That Met QC Criteria