

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BG | TÜV Rheinland Nederland | General use | Unpublished internal data |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 | MDR Criteria | Self-measurement | Published evidence |
Consumer Body | Year(s) | Level | Comment | |
BG | Choice (Australia) | Latest: 2019 | A | |
BG | Amazon Best Sellers (US) | Latest: 2019 | B (3.2 / 5) |
Brazg RL, Klaff LJ, Sussman AM. New Generation Blood Glucose Monitoring System Exceeds International Accuracy Standards. J Diabetes Sci Technol. 2016 Nov 1;10(6):1414-1415. doi: 10.1177/1932296816652902. PMID: 27271844. Available from: PMC5094330.
15197:2013 - Pass General population
Pleus S, Baumstark A, Jendrike N, Mende J, Link M, Zschornack E, Haug C, Freckmann G. System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015. BMJ Open Diabetes Res Care. 2020 Jan;8(1):e001067. doi: 10.1136/bmjdrc-2019-001067. PMID: 31958308. Available from: drc.bmj.com.
15197:2013 - Pass General population (Note: Modified protocol: One reagent system lot. Also passes the more stringent criterion of at least 95% of values within ±10 mg/dL (0.56 mmol/L) or ±10% of the reference measurement procedure’s results.)
SKUP. Report from the evaluation SKUP/2017/112: Accu-Chek Guide (Roche Diagnostics), a system for blood glucose measurement. Bergen, Norway: SKUP; 2017. 47 p. Available from: skup.org.
15197:2013 - Pass General population (Note: BLS-recorded measurements)
15197:2013 - Pass General population (Note: Subject-recorded measurements)
Harvey C, Koubek R, Bégat V, Jacob S. Usability Evaluation of a Blood Glucose Monitoring System With a Spill-Resistant Vial, Easier Strip Handling, and Connectivity to a Mobile App: Improvement of Patient Convenience and Satisfaction. J Diabetes Sci Technol. 2016 Aug 22;10(5):1136-41. doi: 10.1177/1932296816658058. PMID: 27390222. Available from: PMC5032967. Print 2016 Sep.
This study found superior usability of the Roche Accu-Chek Guide over the participants’ current meters in both the United States and France.