Performance of the Dexcom G6 Continuous Glucose Monitoring System in Pregnant Women with Diabetes

Abstract

Background: The aim of this study was to determine the performance of the Dexcom G6 continuous glucose monitoring (CGM) system across three sensor wear sites in pregnant women with diabetes in the second or third trimesters. Methods: Participants with type 1 (T1D), type 2 (T2D), or gestational (GDM) diabetes mellitus were enrolled at 3 sites. Each wore two G6 sensors on the abdomen, upper buttock, and/or posterior upper arm for 10 days and underwent a six-hour clinic session between days 3 and 7 of sensor wear, during which YSI reference blood glucose values were obtained every 30 minutes. No intentional glucose manipulations were performed. Accuracy metrics included the proportion of CGM values that were within ±20% of paired reference values >100 mg/dL or ±20 mg/dL of YSI values ≤100 mg/dL (hereafter referred to as %20/20), as well the analogous %15/15, %30/30 and %40/40. Mean absolute relative difference (MARD) between CGM-YSI pairs was also calculated. Results: Thirty-two participants with T1D (n=20), T2D (n=3), or GDM (n=9) were enrolled; 19 were in the second trimester and 13 were in the third trimester of pregnancy. Compared to the reference, 92.5% of CGM values were within ±20%/20 mg/dL. The overall MARD and that of sensors worn on the abdomen, upper buttock, and posterior upper arm was 10.3%, 11.5%, 11.2%, and 8.7%, respectively. There were no device-related adverse events. Skin reactions at the insertion sites were absent or minor. Conclusions: The Dexcom G6 CGM system is accurate and safe in pregnant women with diabetes.

Accuracy of the Dexcom G6 Glucose Sensor during Aerobic, Resistance, and Interval Exercise in Adults with Type 1 Diabetes

“…With mean ARD ranging from 11.2 to 15.9% during aerobic, resistance and HIIT exercises, this study observed somewhat reduced numeric accuracy compared to recent at-rest results of the G6 system in pregnant women with diabetes for example (mean ARD 8.7–11.5%) [ 33 ]. Many variables may impact the readings of interstitial glucose during exercise and describing these as errors in accuracy is in part misleading.…”

“…As CGM devices continue to evolve and improve their accuracy, additional studies are required to characterize how well they perform during exercise. Although the general accuracy of the latest factory-calibrated Dexcom G6 system has been examined [ 32 , 33 ], no study has yet assessed the impact that exercise has on the accuracy of this sensor.…”

Benefits of Real-Time Continuous Glucose Monitoring in Pregnancy

“…It is accurate enough to replace self-monitoring of blood glucose (SMBG) for precise prandial insulin dosing in type 1 diabetes pregnancy and is also CE marked for use during pregnancies complicated by type 1 diabetes, type 2 diabetes, and gestational diabetes. 2 The Dexcom G6 further benefits from its interoperability, meaning that it can be used either as a standalone real-time CGM system for those using insulin pumps or multiple daily injections or together with a subcutaneous insulin pump (currently a DANA pump in Europe or Tandem T-slim pump in North America) as part of an automated insulin delivery system. As evidence supporting the use of CGM in pregnancy continues to build, it is important to understand how CGM can be leveraged to improve pregnancy outcomes as well as to better characterize the relationship between maternal glycemia and diabetes-related complications in pregnancy.…”

“…The Dexcom G6 is a game changer in terms of a real-time CGM with hypoglycemia alerts and alarms. It is accurate enough to replace self-monitoring of blood glucose (SMBG) for precise prandial insulin dosing in type 1 diabetes pregnancy and is also CE marked for use during pregnancies complicated by type 1 diabetes, type 2 diabetes and gestational diabetes 2 . The Dexcom G6 further benefits from its interoperability meaning that it can be used either as a standalone real-time CGM system for those using insulin pumps or multiple daily injections or together with a subcutaneous insulin pump (currently a DANA pump in Europe or Tandem T-slim pump in North America) as part of an automated insulin delivery system.…”

Continuous Glucose Monitoring in the Intensive Care Unit Following Total Pancreatectomy with Islet Autotransplantation in Children: Establishing Accuracy of the Dexcom G6 Model

“…This system allows for frequent sampling of calculated glucose levels without the need for repetitive fingerstick testing by glucometer. The Dexcom G6 CGM system (Dexcom Inc., San Diego, CA, USA) is one of two FDA-approved systems to replace fingerstick glucose monitoring without requiring the entry of glucometer values for calibration [ 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 ]. Both the FreeStyle Libre and Dexcom G6 system have similar reported accuracies, however the FreeStyle Libre was not approved for use in children at the initiation of this study [ 3 , 4 ].…”