Diabetes technology

Accuracy of the 15.5-Day G7 integrated CGM (iCGM) in Adults with Diabetes

Diabetes Technol TherPublished Prospective accuracy study

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 modelOverall mean absolute relative difference (MARD)%15/15%20/20%30/30%40/40
15-day G7 iCGM8.0%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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