An observational study in Fever, sponsored by Baby FM Doo. Completed at 1 site in Serbia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Baby FM Doo · Observational
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.
438 studies on the registry are indexed under Fever; 55 are open to participants now.
This study's enrollment of 40 is below the median of 408 across 140 observational studies indexed under Fever.
Browse Fever studies →This is the only study on the registry with Baby FM Doo as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Up to 40 eligible participants with disease and/or condition that results in body temperature variation will be included in the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Correlation Coefficient
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.
Time frame: Up to 72 hours
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.
Time frame: Up to six days
40 participants were enrolled in the study at the University Clinical Center of Serbia between December 2024 and April 2026.
| Milestone | Baby FM Group |
|---|---|
| Started | 40 |
| Completed | 40 |
| Not completed | 0 |
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.
| Correlation coefficient (r) | Baby FM Group |
|---|---|
| Correlation Coefficient | 0.830 (0.805 to 0.853) |
The number and percentage of adverse events related to the investigational product will be evaluated and summarized.
| Adverse event | Baby FM Group |
|---|---|
| Frequency of Device and Procedure Related Adverse Events | 0 |
Collected over Up to 6 days per participant.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Baby FM Group | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
All participants have baseline measurements.
| Age, Continuous(years) | Baby FM |
|---|---|
| Mean | 55 ± 18.6 |
| Sex: Female, Male(Participants) | Baby FM |
|---|---|
| Female | 17 |
| Male | 23 |
| Race and Ethnicity Not Collected(Participants) | Baby FM |
|---|
| Axillary hair(Participants) | Baby FM |
|---|---|
| Count of participants | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2024 to primary completion in Jun 2026, 18 months.
Results were first posted in Nov 2026, 4 months after primary completion.
Of 61 observational studies under Fever, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's 18 months is below that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 4, 2026: primary completion Jul 2026 → Jun 2026 and completion Jul 2026 → Jun 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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