Performance of the Dexcom G7 Continuous Glucose Monitoring System in Pregnant Women with Diabetes

Sarit Polsky, Amy M. Valent, Elvira Isganaitis, Kristin Castorino, Grenye O'Malley, Stayce E. Beck, Peggy Gao, Lori M. Laffel, Florence M. Brown, Carol J. Levy

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

Abstract

Background: We evaluated accuracy and safety of a seventh-generation real-time continuous glucose monitoring (CGM) system during pregnancy. Materials and Methods: Evaluable data for accuracy analysis were obtained from 96 G7 sensors (Dexcom, Inc.) worn by 96 of 105 enrolled pregnant women with type 1 (n = 59), type 2 (n = 21), or gestational diabetes (n = 25). CGM values were compared with arterialized venous glucose values from the YSI comparator instrument during 6-h clinic sessions at different time points throughout the sensors' 10-day wear period. The primary endpoint was the proportion of CGM values in the 70-180 mg/dL range within 15% of comparator glucose values. Secondary endpoints included the proportion of CGM values within 20% or 20 mg/dL of comparator values ≥ or <100 mg/dL, respectively (the %20/20 agreement rate). Results: Of the 1739 pairs with CGM in the 70-180 mg/dL range, 83.2% were within 15% of comparator values. The lower bound of the 95% confidence interval was 79.8%. Of the 2102 pairs with CGM values in the 40-400 mg/dL range, the %20/20 agreement rate was 92.5%. Of the 1659 pairs with comparator values in the 63-140 mg/dL range, the %20/20 agreement rate was 92.3%. The %20/20 agreement rates on days 1, 4 and 7, and 10 were 78.6%, 96.3%, and 97.3%, respectively. Consensus error grid analysis showed 99.8% of pairs in the clinically acceptable A and B zones. There were no serious adverse events. The sensors' 10-day survival rate was 90.3%. Conclusion: The G7 system is accurate and safe during pregnancies complicated by diabetes and does not require confirmatory fingerstick testing. Clinical Trial Registration: clinicaltrials.gov

Original languageEnglish
Pages (from-to)307-312
Number of pages6
JournalDiabetes Technology and Therapeutics
Volume26
Issue number5
DOIs
StatePublished - 1 May 2024

Keywords

  • Accuracy
  • Continuous glucose monitoring
  • Dexcom G7
  • Gestational Diabetes
  • Pregnancy
  • Safety

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