Continuos Body Temperature Monitoring

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: Recruiting
• Conditions: Fever
• Intervention / Treatment: Diagnostic test: Continous body temperature monitoring

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Ivan Soldatovic; Phone Number: +381641772077; Email: soldatovic.ivan@gmail.com

Study Locations

• Serbia
  • Other/Not Applicable
    • Belgrade, Other/Not Applicable, Serbia, 11000
      • Recruiting
      • University Clinical Center of Serbia, Clinic for Infectious and Tropical Diseases
      • Contact: Nikola Mitrovic, MD, PhD; Phone Number: +381641772077; Email: nikolabmi@gmail.com
      • Contact: Uros Karic, MD; Email: uroskaric@gmail.com
      • Principal Investigator: Nikola Mitrovic, MD, PhD
      • Sub-Investigator: Uros Karic, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between device for continous body temperature monitoring and standard thermometer	The correlation between temperature measurements with the standard hospital thermometer (with galium) is expected to be high	up to 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of device and procedure related adverse events	The number and percentage of adverse events related to the investigational product will be evaluated and summarized.	up to six days

Collaborators and Investigators

• Sponsor: Baby FM Doo

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2024
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: June 2, 2024
• First Submitted That Met QC Criteria: June 2, 2024
• First Posted (Actual): June 7, 2024

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Fever
• Other Study ID Numbers: BABYFM-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No