|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|BG||TÜV Rheinland Nederland||General use||Unpublished internal data|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||Published evidence|
|BG||Choice (Australia)||Latest: 2019||A|
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
Baumstark A, Jendrike N, Pleus S, Haug C, Freckmann G. Evaluation of Accuracy of Six Blood Glucose Monitoring Systems and Modeling of Possibly Related Insulin Dosing Errors. Diabetes Technol Ther. 2017 Oct;19(10):580-8. Epub: 2017 Jul 13. doi: 10.1089/dia.2016.0408. PMID: 28704063.
15197:2013 General population
Six devices were validated in the study (the Roche Accu-Chek Aviva Nano, the Roche Accu-Chek Mobile, the Roche Accu-Chek Performa Nano, the Ascensia Contour Next Link 2.4, the Abbott FreeStyle Lite and the J&J LifeScan OneTouch Verio IQ). According to the abstract, one of them failed but it does not state which one.
Tentolouris A, Eleftheriadou I, Grigoropoulou P, Nikoloudi M, Siami E, Tsilimigras DI, Tentolouris N. Accuracy and Usability Evaluation of Six Commercially Available Blood Glucose Monitoring Systems Journal of Clinical and Diagnostic Research. 2018 Jun;12(6):OC10-OC14. doi: 10.7860/JCDR/2018/34055.11671. Available from: www.jcdr.net.
Ad Hoc protocol General population (Note: Tested in criteria resembling ISO 15197:2013.)
Grady M, Campbell D, MacLeod K, Srinivasan A. Evaluation of a blood glucose monitoring system with automatic high- and low-pattern recognition software in insulin-using patients: pattern detection and patient-reported insights. J Diabetes Sci Technol. 2013 Jul 1;7(4):970-8. doi: 10.1177/193229681300700419. PMID: 23911178. Available from: PMC3879761.
The publication evaluates the performance of the LifeScan OneTouch VerioIQ, though not in a formal validation.
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 LifeScan OneTouch Verio IQ being used as a reference device for comparison with the Dexcom G4 Platinum.
Massa GG, Gys I, Op't Eyndt A, Bevilacqua E, Wijnands A, Declercq P, Zeevaert R. Evaluation of the FreeStyle® Libre Flash Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes. Horm Res Paediatr. 2018;89(3):189-99. Epub: 2018 Mar 27. doi: 10.1159/000487361. PMID: 29587254.
Comparison in children and adolescents with T1DM (aged 4 to 18 years) (along with the Roche Accu-Chek Mobile and the Bayer Contour Next Link) to the Abbott FreeStyle Libre Flash (n=17). Authors conclude reasonable agreement but with large interindividual variability and that further studies in children are imperative.
Katz LB, Grady M, Setford J, Levy BL. OneTouch Blood Glucose Monitoring Systems – Impact of New Technologies on the Efficacy of Self-monitoring Blood Glucose US Endocrinology. 2018 Jan;14(Suppl 1):2-8. Epub: 2018 Jan 22. Available from: www.touchendocrinology.com.
Given the struggles that many patients have with ongoing adherence, motivation, health literacy and/or numeracy, the newer BGMS features described in this article represent important tools which may help HCPs better communicate with their patients on how to both understand their BG data and encourage appropriate self-management from their patients.