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Accuracy and Safety of Dexcom G7 Continuous Glucose Monitoring in Adults with Diabetes

Open access
Garg, Satish K., Kipnes, Mark, Castorino, Kristin, Bailey, Timothy S., Akturk, Halis Kaan, Welsh, John B., Christiansen, Mark P., Balo, Andrew K., Brown, Sue A., Reid, Jennifer L., Beck, Stayce E.·2022·Diabetes Technology & Therapeutics
DOI 10.1089/dia.2022.0011PMC PMC9208857
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Abstract

Background: We evaluated the accuracy and safety of a seventh generation (G7) Dexcom continuous glucose monitor (CGM) during 10.5 days of use in adults with diabetes. Methods: Adults with either type 1 or type 2 diabetes (on intensive insulin therapy or not) participated at 12 investigational sites in the United States. In-clinic visits were conducted on days 1 or 2, 4 or 7, and on the second half of day 10 or the first half of day 11 for frequent comparisons with comparator blood glucose measurements obtained with the YSI 2300 Stat Plus glucose analyzer. Participants wore sensors concurrently on the upper arm and abdomen. Accuracy evaluation included the proportion of CGM values within 15% of comparator glucose levels >100 mg/dL or within 15 mg/dL of comparator levels ≤100 mg/dL (%15/15), along with the %20/20 and %30/30 agreement rates. The mean absolute relative difference (MARD) between temporally matched CGM and comparator values was also calculated. Results: Data from 316 participants (619 sensors, 77,774 matched pairs) were analyzed. For arm- and abdomen-placed sensors, overall MARDs were 8.2% and 9.1%, respectively. Overall %15/15, %20/20, and %30/30 agreement rates were 89.6%, 95.3%, and 98.8% for arm-placed sensors and were 85.5%, 93.2%, and 98.1% for abdomen-placed sensors. Across days of wear, glucose concentration ranges, and rates of change, %20/20 agreement rates varied by no more than 9% from the overall %20/20. No serious adverse events were reported. Conclusions: The G7 CGM provides accurate glucose readings with single-digit MARD with arm or abdomen placement in adults with diabetes. Clinicaltrials.gov: NCT04794478

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Figures

FIG. 1. G7 components (left to right) include an optional receiver and display unit, packaging, the wearable sensor/transmitter, and the applicator. The wearable measures 24 × 27.3 × 4.6 mm, roughly the size of three stacked quarters. G7, seventh generation.
FIG. 1. G7 components (left to right) include an optional receiver and display unit, packaging, the wearable sensor/transmitter, and the applicator. The wearable measures 24 × 27.3 × 4.6 mm, roughly the size of three stacked quarters. G7, seventh generation.CC BY · PubMed Central
FIG. 2. Aggregated sensor MARD (%) of CGM-YSI histogram plot for 619 sensors placed on the arm or abdomen. CGM-YSI; MARD, mean absolute relative difference.
FIG. 2. Aggregated sensor MARD (%) of CGM-YSI histogram plot for 619 sensors placed on the arm or abdomen. CGM-YSI; MARD, mean absolute relative difference.CC BY · PubMed Central

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Research works printed but not linked: 1

  1. Calhoun P, , Puhr S, , Welsh JB, et al.: Lag time of a sixth-generation continuous glucose monitoring system. J Diabetes Sci Technol, 2018; 13:308.

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Metadata

Authors
Garg, S. K., Kipnes, M., Castorino, K., Bailey, T. S., Akturk, H. K., Welsh, J. B., Christiansen, M. P., Balo, A. K., Brown, S. A., Reid, J. L., & Beck, S. E.
Affiliations
  • University of Colorado Anschutz (US)
  • DGD Clinic, San Antonio, Texas, USA.
  • Sansum Diabetes Research Institute (US)
  • AMCR Institute (US)
  • Department of Medicine and Pediatrics, Barbara Davis Center for Diabetes, University of Colorado, Aurora, Colorado, USA.
  • Dexcom (United States) (US)
  • Diablo Clinical Research (US)
  • University of Virginia (US)
Corresponding author
Garg, Satish K.
ORCID
Venue
Diabetes Technology & Therapeutics
Publisher
SAGE Publications
Published
2022-05-31
Volume
24
Issue
6
Pages
373-380
ISSN
  • 1520-9156 (ISSN-L)
  • 1557-8593
DOI
10.1089/dia.2022.0011
PMC
PMC9208857
OpenAlex
W4212853509
Cited by
179
References
17
Citations by year
2026: 44 · 2025: 63 · 2024: 37 · 2023: 23 · 2022: 12
FWCI
25.02
Type
journal article
Language
en
Open access
Licence
Locations
  • Diabetes Technology & Therapeutics (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
Keywords
Dexcom G7, continuous glucose monitoring, type 1 diabetes, type 2 diabetes, sensor accuracy, mean absolute relative difference, sensor placement, intensive insulin therapy, device safety
MeSH terms
Adult, Blood Glucose, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Glucose, Humans, Blood Glucose Self-Monitoring, Reproducibility of Results

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