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. 2020 Dec;22(12):943-947.
doi: 10.1089/dia.2020.0085.

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

Kristin Castorino  1 , Sarit Polsky  2 , Grenye O'Malley  3 , Camilla Levister  3 , Kristen Nelson  1 , Christian Farfan  1 , Scott Brackett  2 , Sarah Puhr  4 , Carol J Levy  3
Affiliations

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

Kristin Castorino et al. Diabetes Technol Ther. 2020 Dec.

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 three sites. Each wore two G6 sensors on the abdomen, upper buttock, and/or posterior upper arm for 10 days and underwent a 6-h clinic session between days 3 and 7 of sensor wear, during which YSI reference blood glucose values were obtained every 30 min. 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 as the analogous %15/15, %30/30, and %40/40. The 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 with 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.

Keywords: Accuracy; Continuous glucose monitoring; Gestational diabetes; Performance; Pregnancy; Safety.

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Conflict of interest statement

S.P. has received research funding from Dexcom, Inc., Sanofi U.S. Services, Eli Lilly, NIDDK, JDRF, and the Helmsley Charitable Trust; has received research support from Diasome Pharmaceuticals, Inc., Lastyle Innovation, Lexicon, Inc., Medtronic MiniMed, Inc., and Sanofi U.S. Services; and is a consultant for JAEB Center for Health Research and is on the Medical Advisory Board for Medtronic MiniMed, Inc. S.P. is an employee of Dexcom, Inc.; C.J.L. has acted on advisory boards for Lilly, Novo Nordisk, Sanofi, and Dexcom, Inc., and has received research funding from NIDDK, JDRF, the Helmsley Charitable Trust, Abbott Diabetes, Dexcom, Inc., and research support from Tandem Diabetes. K.C., K.N., and C.F. have received research funding from Dexcom, NIDDK, Abbott Diabetes, Medtronic, Insulet, Mylan Pharmaceuticals, and Eli Lilly.

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