Performance, Safety and Usability of a Third-Generation Continuous Glucose Monitoring System in a Pediatric Population: Results From a Prospective, Multicenter Study
Authors' conclusion
In a pediatric population, the novel CGM system demonstrated accurate and stable performance across its 15-day wear life and showed high usability.
Study context
- Population
- Pediatric participants aged 2 to 17 years, 3 clinical centresper-protocol set
- Participants
- 75 participants
- Outcome
- MARD vs laboratory venous blood glucose
Methodological detailsmulticentre, per-protocol analysis, Participants randomized to performance assessment on days 1 and 2, days 7 to 9 or days 15 and 16
- Multicentre
- Per-protocol analysis
- Participants randomized to performance assessment on days 1 and 2, days 7 to 9 or days 15 and 16
Main finding
As reported in the abstract
Overall mean absolute relative difference (MARD)
8.89%
MARD days 1 and 2
8.65%
MARD days 7 to 9
8.70%
MARD days 15 and 16
9.30%
Observational data: associations, not effects.
Further findings
DTS error grid: data pairs in zones A+B
- Data pairs in clinically acceptable zones A+B
- 100.0%
True alarm rates
- Hypoglycemia
- 98.6%
- Hyperglycemia
- 98.8%
Sensor wear life
- Mean sensor wear life
- 14.4 days
Usability
- High participant/guardian satisfaction with system assembly, sensor insertion and overall comfort
Safety
- No device-related or skin-related adverse events were reported
Original publication
Performance, Safety and Usability of a Third-Generation Continuous Glucose Monitoring System in a Pediatric Population: Results From a Prospective, Multicenter Study. J Diabetes Sci Technol. Published 19 July 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →