| 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| BG | TÜV Rheinland Nederland | General use | Unpublished internal data |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 | Published evidence |
| Consumer Body | Year(s) | Level | Comment | |
| BG | Consumer Reports (US) | Latest: 2019-2022 | Excellent |
Freckmann G, Baumstark A, Jendrike N, Zschornack E, Kocher S, Tshiananga J, Heister F, Haug C. System accuracy evaluation of 27 blood glucose monitoring systems according to DIN EN ISO 15197. Diabetes Technol Ther. 2010 Mar;12(3):221-31. doi: 10.1089/dia.2009.0128. PMID: 20151773.
15197:2003 - Pass General population
Tack C, Pohlmeier H, Behnke T, Schmid V, Grenningloh M, Forst T, Pfützner A. Accuracy evaluation of five blood glucose monitoring systems obtained from the pharmacy: a European multicenter study with 453 subjects. Diabetes Technol Ther. 2012 Apr;14(4):330-7. Epub: 2011 Dec 16. doi: 10.1089/dia.2011.0170. PMID: 22176154.
15197:2003 - Pass General population
15197:2013 - Pass General population
Baumstark A, Pleus S, Schmid C, Link M, Haug C, Freckmann G. Lot-to-lot variability of test strips and accuracy assessment of systems for self-monitoring of blood glucose according to ISO 15197. J Diabetes Sci Technol. 2012 Sep 1;6(5):1076-86. doi: 10.1177/193229681200600511. PMID: 23063033. Available from: PMC3570841.
15197:2003 - Pass General population (Note: 4 test-strip lots; all 4 within requirements)
Freckmann G, Schmid C, Baumstark A, Pleus S, Link M, Haug C. System accuracy evaluation of 43 blood glucose monitoring systems for self-monitoring of blood glucose according to DIN EN ISO 15197. J Diabetes Sci Technol. 2012 Sep 1;6(5):1060-75. PMID: 23063032. Available from: PMC3570840.
15197:2003 - Pass General population
15197:2013 - Pass General population
Zueger T, Schuler V, Stettler C, Diem P, Christ ER. Assessment of three frequently used blood glucose monitoring devices in clinical routine. Swiss Med Wkly. 2012 Jul 12;142:w13631. doi: 10.4414/smw.2012.13631. PMID: 22791566. eCollection 2012.
15197:2003 - Pass General population (Note: Reference device: HemoCue Glucose 201+)
Parwaiz M, Lunt H, Florkowski CM, Logan FJ, Irons L, Perwick C, Frampton CM, Moore MP. Assessment of glucose meter performance at the antenatal diabetes clinic: exploration of patient-related and pre-analytical factors. Ann Clin Biochem. 2014 Jan 5;51(Pt 1):47-53. Epub: 2013 Sep 3. doi: 10.1177/0004563213487893. PMID: 24003257.
15197:2013 - Pass General population
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
Sølvik UØ, Risa M, Jacobsen CE, Monsen G, Sandberg S. Performance of 10 Systems for Self-Monitoring of Blood Glucose by Trained Healthcare Professionals and in the Hands of the Users. Clin Chem. 2015 May;61(5):772-4. Epub: 2015 Mar 3. doi: 10.1373/clinchem.2014.236760. PMID: 25737533. Available from: clinchem.aaccjnls.org.
15197:2013 - Pass General population (Note: BLS-recorded measurements)
FDA:2016H - Pass General population (Note: BLS-recorded measurements)
15197:2013 - Pass General population (Note: Subject-recorded measurements)
FDA:2016H - Pass General population (Note: Subject-recorded measurements)
15197:2003 - Pass General population
SKUP Evaluations 2007/64, 2010/89
Sutheran HL, Reynolds T. Technical and clinical accuracy of three blood glucose meters: clinical impact assessment using error grid analysis and insulin sliding scales. J Clin Pathol. 2016 Oct;69(10):899-905. Epub: 2016 Feb 5. doi: 10.1136/jclinpath-2015-203339. PMID: 26850631.
15197:2003 General population
From the absract, it appears that an evaluation of the Abbott FreeStyle Lite, the Roche Accu-Chek Aviva and an unnamed third device was performed. Neither the protocol used nor the results are clear from the abstract.
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.
Klonoff DC, Parkes JL, Kovatchev BP, Kerr D, Bevier WC, Brazg RL, Christiansen M, Bailey TS, Nichols JH, Kohn MA. Investigation of the Accuracy of 18 Marketed Blood Glucose Monitors. Diabetes Care. 2018 Aug;41(8):1681-8. Epub: 2018 Jun 13. doi: 10.2337/dc17-1960. PMID: 29898901. Available from: www.diabetestechnology.org.
DTS:2016 - Pass General population
SKUP. Report from the evaluation SKUP/2007/64: Freestyle Lite (Abbott Diabetes Care), a system for blood glucose measurement. Bergen, Norway: SKUP; 2007. 44 p. Available from: skup.org.
15197:2003 - Pass General population
Results counted in Sølvik et al. 2015.
SKUP. Report from the evaluation SKUP/2010/89: FreeStyle Lite (Abbott Diabetes Care), a system for blood glucose measurement. Bergen, Norway: SKUP; 2010. 44 p. Available from: skup.org.
15197:2013 - Pass General population (Note: BLS-recorded measurements)
Results counted in Sølvik et al. 2015.
Hoss U, Budiman ES, Liu H, Christiansen MP. Feasibility of Factory Calibration for Subcutaneous Glucose Sensors in Subjects With Diabetes. J Diabetes Sci Technol. 2014 Jan;8(1):89-94. Epub: 2014 Jan 1. doi: 10.1177/1932296813511747. PMID: 24876543. Available from: PMC4454101.
Measurements from the Abbott FreeStyle Lite are compared to those from the Abbott FreeStyle Navigator, though not in a formal validation.
Fingerstick and wired-enzyme technologies are compared.
Klaff LJ, Brazg R, Hughes K, Tideman AM, Schachner HC, Stenger P, Pardo S, Dunne N, Parkes JL. Accuracy evaluation of contour next compared with five blood glucose monitoring systems across a wide range of blood glucose concentrations occurring in a clinical research setting. Diabetes Technol Ther. 2015 Jan;17(1):8-15. doi: 10.1089/dia.2014.0069. PMID: 25260047.
Measurements from the Abbott FreeStyle Lite are compared to those from the Ascensia (Bayer) Contour Next and, indirectly, the Roche Accu-Chek Aviva Nano, the J&J LifeScan OneTouch Ultra 2, the J&J LifeScan OneTouch Verio Pro and the Nipro Truetrack, though not in a formal validation.
McGrath RT, Donnelly VC, Glastras SJ, Preda VA, Sheriff N, Ward P, Hocking SL, Fulcher GR. Evaluation of Blood Glucose Meter Efficacy in an Antenatal Diabetes Clinic. Diabetes Technol Ther. 2016 Feb;18(2):68-74. Epub: 2015 Oct 6. doi: 10.1089/dia.2015.0104. PMID: 26440810. Available from: PMC5519155. Retraction in: Diabetes Technol Ther. 2017 Jun;19(6):382.
Retraction of: RT McGrath, et al; Evaluation of Blood Glucose Meter Efficacy in an Antenatal Diabetes Clinic. Diabetes Technol Ther. 2016;18(2):68–74. DOI: 10.1089/dia.2015.0104 Diabetes Technol Ther. 2017 Jun. 382 p. doi: 10.1089/dia.2015.0104.retract. PMID: 28541796. Available from: PMC5519155.