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Continuos Body Temperature Monitoring

NCT06447337 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2026-01-28

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Continous body temperature monitoring

The investigational product will be placed on the participants' body in axilar joint and connected to the mobile phone. The values of the current temperature will apear on the monitor and it will be recorded in the database with date and time for each record. In parallel, study staff will occasionally measure the temperature using standard hospital thermometer.

Sponsors & Collaborators

  • Baby FM Doo

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-16
Primary Completion
2026-07-30
Completion
2026-07-30

Countries

  • Serbia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06447337 on ClinicalTrials.gov