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Accuracy Assessment | Recommendation | Basis | |
BG | Medaval | ★★★ Recommendation | Recent clinical validation; recent protocol; multiple clinical validations |
BG | TÜV Rheinland Nederland | General use | Unpublished internal data |
BG | Institute of Health Economics (CA) | General use | No evidence provided |
BG | MDR Criteria | Self-measurement and professional use | Published evidence |
Consumer Body | Year(s) | Level | Comment | |
BG | Consumer Reports (US) | Previous: 2019 | Excellent |
Hasslacher C, Kulozik F, Platten I. Analytical performance of glucose monitoring systems at different blood glucose ranges and analysis of outliers in a clinical setting. J Diabetes Sci Technol. 2014 May;8(3):466-72. Epub: 2014 Feb 18. doi: 10.1177/1932296814522804. PMID: 24876607. Available from: PMC4455429.
15197:2013 - Pass General population
Bedini JL, Wallace JF, Pardo S, Petruschke T. Performance Evaluation of Three Blood Glucose Monitoring Systems Using ISO 15197: 2013 Accuracy Criteria, Consensus and Surveillance Error Grid Analyses, and Insulin Dosing Error Modeling in a Hospital Setting. J Diabetes Sci Technol. 2016 Jan;10(1):85-92. Epub: 2015 Oct 7. doi: 10.1177/1932296815609368. PMID: 26445813. Available from: PMC4738222.
15197:2013 - Pass General population
Laffel L. Improved Accuracy of Continuous Glucose Monitoring Systems in Pediatric Patients with Diabetes Mellitus: Results from Two Studies. Diabetes Technol Ther. 2016 Feb;18(Suppl 2):S223-33. doi: 10.1089/dia.2015.0380. PMID: 26784126. Available from: PMC4717517.
The publication describes the Bayer Contour Next USB being used as a reference device for comparison with the Dexcom G4 Platinum.