Accuracy of the 15.5-Day G7 integrated CGM (iCGM) in Adults with Diabetes
Authors' conclusion
The 15-day G7 iCGM was accurate and safe in adults with diabetes throughout the 15.5-day wear period.
Study context
- Population
- Adults (age ≥18 years) with T1D or T2D, six US sites; mean ± SD age 43.0 ± 14.4 years, 53.1% female, 86.9% T1D
- Participants
- 130 adults20,310 CGM-YSI matched pairs
- Comparison
- 15-day G7 iCGM vs Yellow Springs Instrument (YSI) 2300 Stat Plus glucose analyzer comparator
- 15-day G7 iCGMn = 130
- Outcome
- Accuracy vs YSI
- Follow-up
- 15.5-day wear period
Methodological detailsmulticenter, six clinical sites in the United States, Four in-clinic visits on days 1-3, 4-7, 9-12 and 13-15.5 with frequent arterialized venous blood draws for YSI comparator, Participants using intensive insulin therapy had deliberate, closely monitored glucose manipulations
- Multicenter
- Six clinical sites in the United States
- Four in-clinic visits on days 1-3, 4-7, 9-12 and 13-15.5 with frequent arterialized venous blood draws for YSI comparator
- Participants using intensive insulin therapy had deliberate, closely monitored glucose manipulations
Performance
As reported in the abstract
| Test or model | Overall mean absolute relative difference (MARD) | %15/15 | %20/20 | %30/30 | %40/40 |
|---|---|---|---|---|---|
| 15-day G7 iCGM | 8.0% | 87.7% | 94.2% | 98.9% | 99.8% |
15-day G7 iCGM
Overall mean absolute relative difference (MARD)8.0%
%15/1587.7%
%20/2094.2%
%30/3098.9%
%40/4099.8%
Further findings
iCGM special controls performance and user experience
- The device exceeded iCGM performance goals, and user experiences were broadly positive
Safety
- No serious adverse events were reported
Original publication
Accuracy of the 15.5-Day G7 iCGM in Adults with Diabetes. Diabetes Technol Ther. Published 20 March 2025. doi:10. 1089/ dia. 2025. 0139
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