Performance Evaluation of Three Continuous Glucose Monitoring Systems: Comparison of Six Sensors Per Subject in Parallel

Overview

Journal J Diabetes Sci Technol

Specialty Endocrinology

Date 2013 Aug 6

PMID 23911165

Citations 36

Authors

Guido Freckmann

Stefan Pleus

Manuela Link

Eva Zschornack

Hans-Martin Klotzer

Cornelia Haug

Affiliations

Soon will be listed here.

Abstract

Background: This study is aimed at comparing the performance of three continuous glucose monitoring (CGM) systems following the Clinical and Laboratory Standards Institute's POCT05-A guideline, which provides recommendations for performance evaluation of CGM systems.

Methods: A total of 12 subjects with type 1 diabetes were enrolled in this study. Each subject wore six CGM systems in parallel, two sensors of each CGM system [FreeStyle Navigator™ (Navigator), MiniMed Guardian® REAL-Time with Enlite sensor (Guardian), DexCom™ Seven® Plus 3rd generation (Seven Plus)]. Each sensor was used for the lifetime specified by the manufacturer. To follow POCT05-A recommendations, glucose excursions were induced on two separate occasions, and venous and capillary blood glucose (BG) concentrations were obtained every 15 min for five consecutive hours. Capillary BG concentrations were measured at least once per hour during the day and once at night. Parameters investigated were CGM-to-BG differences [mean absolute relative difference (MARD)] and sensor-to-sensor differences [precision absolute relative difference (PARD)].

Results: Compared with capillary BG reference readings, the Navigator showed the lowest MARD, with 12.1% overall and 24.6% in the hypoglycemic range; for the Guardian and the Seven Plus, MARD was 16.2%/34.9% and 16.3%/32.7%, respectively. PARD also was lowest for the Navigator (9.6%/9.8%), followed by the Seven Plus (16.7%/25.5%) and the Guardian (18.1%/20.2%). During induced glucose excursions, MARD between CGM and BG was, again, lowest for the Navigator (14.3%), followed by the Seven Plus (15.8%) and the Guardian (19.2%).

Conclusions: In this study, two sensors of each of the three CGM systems were compared in a setting following POCT05-A recommendations. The Navigator CGM system achieved more accurate results than the Guardian or the Seven Plus with respect to MARD and PARD. Performance in the hypoglycemic range was markedly worse for all CGM systems when compared with BG results.

Citing Articles

Feasibility of a Glucose Manipulation Procedure for the Standardized Performance Evaluation of Continuous Glucose Monitoring Systems.

Link M, Eichenlaub M, Waldenmaier D, Wehrstedt S, Pleus S, Jendrike N J Diabetes Sci Technol. 2025; :19322968251317526.

PMID: 39989334 PMC: 11848859. DOI: 10.1177/19322968251317526.

Analytical Performance of the FreeStyle Libre 2 Glucose Sensor in Healthy Male Adults.

Fellinger E, Brandt T, Creutzburg J, Rommerskirchen T, Schmidt A Sensors (Basel). 2024; 24(17).

PMID: 39275680 PMC: 11397946. DOI: 10.3390/s24175769.

Clinical Performance Evaluation of Continuous Glucose Monitoring Systems: A Scoping Review and Recommendations for Reporting.

Freckmann G, Eichenlaub M, Waldenmaier D, Pleus S, Wehrstedt S, Haug C J Diabetes Sci Technol. 2023; 17(6):1506-1526.

PMID: 37599389 PMC: 10658695. DOI: 10.1177/19322968231190941.

Mixed Meal Tolerance Test Versus Continuous Glucose Monitoring for an Effective Diagnosis of Persistent Post-Bariatric Hypoglycemia.

Ramos-Levi A, Rubio-Herrera M, Matia-Martin P, Perez-Ferre N, Marcuello C, Sanchez-Pernaute A J Clin Med. 2023; 12(13).

PMID: 37445330 PMC: 10342744. DOI: 10.3390/jcm12134295.

Comparison of the clinical effects of intermittently scanned and real-time continuous glucose monitoring in children and adolescents with type 1 diabetes: A retrospective cohort study.

Urakami T, Terada H, Yoshida K, Kuwabara R, Mine Y, Aoki M J Diabetes Investig. 2022; 13(10):1745-1752.

PMID: 35532954 PMC: 9533045. DOI: 10.1111/jdi.13830.

References

Keenan D, Mastrototaro J, Zisser H, Cooper K, Raghavendhar G, Lee S . Accuracy of the Enlite 6-day glucose sensor with guardian and Veo calibration algorithms. Diabetes Technol Ther. 2011; 14(3):225-31. DOI: 10.1089/dia.2011.0199. View

Adolfsson P, Ornhagen H, Eriksson B, Cooper K, Jendle J . Continuous glucose monitoring--a study of the Enlite sensor during hypo- and hyperbaric conditions. Diabetes Technol Ther. 2012; 14(6):527-32. DOI: 10.1089/dia.2011.0284. View

Pleus S, Schmid C, Link M, Zschornack E, Klotzer H, Haug C . Performance evaluation of a continuous glucose monitoring system under conditions similar to daily life. J Diabetes Sci Technol. 2013; 7(4):833-41. PMC: 3879747. DOI: 10.1177/193229681300700405. View

Clarke W, Anderson S, Farhy L, Breton M, Gonder-Frederick L, Cox D . Evaluating the clinical accuracy of two continuous glucose sensors using continuous glucose-error grid analysis. Diabetes Care. 2005; 28(10):2412-7. DOI: 10.2337/diacare.28.10.2412. View

Facchinetti A, Sparacino G, Guerra S, Luijf Y, DeVries J, Mader J . Real-time improvement of continuous glucose monitoring accuracy: the smart sensor concept. Diabetes Care. 2012; 36(4):793-800. PMC: 3609535. DOI: 10.2337/dc12-0736. View

Kamath A, Mahalingam A, Brauker J . Analysis of time lags and other sources of error of the DexCom SEVEN continuous glucose monitor. Diabetes Technol Ther. 2009; 11(11):689-95. DOI: 10.1089/dia.2009.0060. View

Garg S, Jovanovic L . Relationship of fasting and hourly blood glucose levels to HbA1c values: safety, accuracy, and improvements in glucose profiles obtained using a 7-day continuous glucose sensor. Diabetes Care. 2006; 29(12):2644-9. DOI: 10.2337/dc06-1361. View

. The accuracy of the Guardian RT continuous glucose monitor in children with type 1 diabetes. Diabetes Technol Ther. 2008; 10(4):266-72. PMC: 2587171. DOI: 10.1089/dia.2007.0279. View

Zijlstra E, Heise T, Nosek L, Heinemann L, Heckermann S . Continuous glucose monitoring: quality of hypoglycaemia detection. Diabetes Obes Metab. 2012; 15(2):130-5. DOI: 10.1111/dom.12001. View

10.

Damiano E, El-Khatib F, Zheng H, Nathan D, Russell S . A comparative effectiveness analysis of three continuous glucose monitors. Diabetes Care. 2013; 36(2):251-9. PMC: 3554299. DOI: 10.2337/dc12-0070. View

11.

Garg S, Zisser H, Schwartz S, Bailey T, Kaplan R, Ellis S . Improvement in glycemic excursions with a transcutaneous, real-time continuous glucose sensor: a randomized controlled trial. Diabetes Care. 2005; 29(1):44-50. DOI: 10.2337/diacare.29.01.06.dc05-1686. View

12.

Zisser H, Bailey T, Schwartz S, Ratner R, Wise J . Accuracy of the SEVEN continuous glucose monitoring system: comparison with frequently sampled venous glucose measurements. J Diabetes Sci Technol. 2010; 3(5):1146-54. PMC: 2769895. DOI: 10.1177/193229680900300519. View

13.

Luijf Y, Avogaro A, Benesch C, Bruttomesso D, Cobelli C, Ellmerer M . Continuous glucose monitoring accuracy results vary between assessment at home and assessment at the clinical research center. J Diabetes Sci Technol. 2012; 6(5):1103-6. PMC: 3570844. DOI: 10.1177/193229681200600514. View

14.

Garg S, Smith J, Beatson C, Lopez-Baca B, Voelmle M, Gottlieb P . Comparison of accuracy and safety of the SEVEN and the Navigator continuous glucose monitoring systems. Diabetes Technol Ther. 2009; 11(2):65-72. DOI: 10.1089/dia.2008.0109. View

15.

Morrow L, Hompesch M, Tideman A, Matson J, Dunne N, Pardo S . Evaluation of a novel continuous glucose measurement device in patients with diabetes mellitus across the glycemic range. J Diabetes Sci Technol. 2011; 5(4):853-9. PMC: 3192590. DOI: 10.1177/193229681100500406. View

16.

Kovatchev B, Anderson S, Heinemann L, Clarke W . Comparison of the numerical and clinical accuracy of four continuous glucose monitors. Diabetes Care. 2008; 31(6):1160-4. PMC: 4607511. DOI: 10.2337/dc07-2401. View

17.

Bailey T, Zisser H, Chang A . New features and performance of a next-generation SEVEN-day continuous glucose monitoring system with short lag time. Diabetes Technol Ther. 2009; 11(12):749-55. DOI: 10.1089/dia.2009.0075. View

18.

Weinstein R, Schwartz S, Brazg R, Bugler J, Peyser T, McGarraugh G . Accuracy of the 5-day FreeStyle Navigator Continuous Glucose Monitoring System: comparison with frequent laboratory reference measurements. Diabetes Care. 2007; 30(5):1125-30. DOI: 10.2337/dc06-1602. View

19.

NIELSEN J, Freckmann G, Kapitza C, Ocvirk G, Koelker K, Kamecke U . Glucose monitoring by microdialysis: performance in a multicentre study. Diabet Med. 2009; 26(7):714-21. DOI: 10.1111/j.1464-5491.2009.02750.x. View

20.

Mastrototaro J, Shin J, Marcus A, Sulur G . The accuracy and efficacy of real-time continuous glucose monitoring sensor in patients with type 1 diabetes. Diabetes Technol Ther. 2008; 10(5):385-90. DOI: 10.1089/dia.2007.0291. View