Performance of a factory-calibrated real-time continuous glucose monitoring system utilizing an automated sensor applicator
Open accessAbstract
Background This study assessed the accuracy of a factory-calibrated 10-day real-time continuous glucose monitoring (CGM) system (G6), which includes an automated sensor applicator. Methods Seventy-six participants with insulin-treated diabetes were enrolled at four U.S. sites as part of a larger study of G6 system performance. In-clinic visits for frequent comparative blood glucose measurements using a reference instrument (YSI) were conducted on days 1, 4-5, 7, and/or 10 of system use. Accuracy evaluation included the proportion of CGM values that were within ±20% of YSI reference value for glucose levels >100 mg/dL and ±20 mg/dL for YSI glucose levels ≤100 mg/dL (%20/20), the analogous %15/15 and %30/30, and the mean absolute relative difference (MARD) between temporally matched CGM and YSI values. Participants calibrated the systems once daily. Raw sensor data were reprocessed using assigned sensor codes and a factory-calibration algorithm. Results Reprocessed data from 62 participants (25 adults and 37 children and adolescents of ages 6-17 years; 3532 YSI-CGM pairs) were analyzed. The G6 system's overall %20/20 was 93.9% (adults, 92.5%; children and adolescents, 96.2%), its %15/15 was 83.3% (adults, 78.3%; children and adolescents, 91.1%), and its MARD was 9.0% (adults, 9.8%; children and adolescents, 7.7%). Overall day-1 %20/20 accuracy was 92.2%, %15/15 was 81.5%, and MARD was 9.3%. Accuracy was maintained across 10 days of use and various glucose concentration ranges i…
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The reported mean absolute relative difference (MARD) for the Dexcom G6 in accuracy studies comparing sensor glucose values with reference blood glucose values is 9.0%.
“The reported mean absolute relative difference (MARD) for the Dexcom G6 in accuracy studies comparing sensor glucose values with reference blood glucose values is 9.0% (9).”
From Continuous Glucose Monitoring Profiles in Healthy Nondiabetic Participants: A Multicenter Prospective Study (2019) · cites this paper as [9]
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- Authors
- Shah, V. N., Laffel, L. M., Wadwa, R. P., & Garg, S. K.
- Affiliations
- University of Colorado Anschutz (US)
- Joslin Diabetes Center (US)
- Corresponding author
- Laffel, Lori M.
- Garg, Satish K.
- Venue
- Diabetes Technology & Therapeutics
- Publisher
- SAGE Publications
- Published
- 2018-06
- Volume
- 20
- Issue
- 6
- Pages
- 428-433
- ISSN
- 1520-9156 (ISSN-L)
- 1557-8593
- PMC
- PMC6422005
- OpenAlex
- W2809055900
- Cited by
- 197
- References
- 7
- Citations by year
- 2026: 20 · 2025: 19 · 2024: 24 · 2023: 27 · 2022: 22 · 2021: 26 · 2020: 24 · 2019: 27 · 2018: 8
- FWCI
- 16.90
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Diabetes Technology & Therapeutics (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Dexcom
- National Institute of Diabetes and Digestive and Kidney Diseases (P30DK036836)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hyperglycemia and glycemic control in critically ill and hospitalized patients
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Keywords
- continuous glucose monitoring, factory calibration, Dexcom G6, sensor accuracy, mean absolute relative difference, insulin-treated diabetes, children and adolescents
- MeSH terms
- Adolescent, Adult, Blood Glucose, Calibration, Child, Computer Systems, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Female, Humans, Male, Middle Aged, Reference Values, Blood Glucose Self-Monitoring, Reproducibility of Results, Young Adult
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