Accuracy Assessment | Recommendation | Basis | |
BG | Medaval | ★★★ Recommendation | Recent clinical validation; recent protocol; multiple clinical validations |
BG | Institute of Health Economics (CA) | General use | No evidence provided |
BG | MDR Criteria | Children and neonates | Published evidence |
Consumer Body | Year(s) | Level | Comment | |
BG | Consumer Reports (US) | Previous: 2019 | Excellent | |
BG | Choice (Australia) | Latest: 2019 | A | |
BG | Amazon Best Sellers (US) | Latest: 2019 | A (4.1 / 5) |
DeSalvo DJ, Shanmugham S, Ly TT, Wilson DM, Buckingham BA. Accuracy evaluation of blood glucose monitoring systems in children on overnight closed-loop control. J Diabetes Sci Technol. 2014 Sep;8(5):969-73. Epub: 2014 May 21. doi: 10.1177/1932296814532238. PMID: 24876427. Available from: PMC4455362.
15197:2003 - Pass Children (Note: Modified protocol)
15197:2013 - Pass Children (Note: Modified protocol)
Dietzen DJ, Nenninger DA, Simmons DA, Pardo S, Pandya M, Fullam J. Analytic characteristics of three Bayer contour blood glucose monitoring systems in neonates. J Diabetes Sci Technol. 2015 Mar;9(2):257-61. Epub: 2014 Nov 4. doi: 10.1177/1932296814557669. PMID: 25377056. Available from: PMC4604584.
15197:2013 - Pass Neonates
CLSI:2013 - Pass Neonates
FDA:2016P - Fail Neonates
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
Al-Zahrani A, Alshareef R, Farahat F, Borai A. Assessing the Accuracy of Different Glucometers Based on the Laboratory Reference Method. Clin Lab. 2020 Oct 1;66(10):200132. doi: 10.7754/Clin.Lab.2020.200132. PMID: 33073954.
Unknown protocol General population
Protocol not stated in abstract.
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 Ascensia (Bayer) Contour Next are compared to those from the Roche Accu-Chek Aviva Nano, the Abbott FreeStyle Lite, the J&J LifeScan OneTouch Ultra 2, the J&J LifeScan OneTouch Verio Pro and the Nipro Truetrack, though not in a formal validation.
Huang E, Demirel S, Bliss C, Savaser D, Castle JR. Reliability of the Dexcom G6 Continuous Glucose Monitor During Hyperbaric Oxygen Exposure. Diabetes Technol Ther. 2020 May;22(5):360-366. Epub: 2020 Feb 6. doi: 10.1089/dia20190390. PMID: 31916854. Available from: PMC7196364.
The Ascensia Contour Next was used as a reference device in this study.
Guillot FH, Jacobs PG, Wilson LM, Youssef JE, Gabo VB, Branigan DL, Tyler NS, Ramsey K, Riddell MC, Castle JR. Accuracy of the Dexcom G6 Glucose Sensor during Aerobic, Resistance, and Interval Exercise in Adults with Type 1 Diabetes. Biosensors (Basel). 2020 Sep 29;10(10):138. doi: 10.3390/bios10100138. PMID: 32814455. Available from: PMC9445332.
The publication describes the Ascensia (Bayer) Contour Next being used as a validation control device.