Ascensia Diabetes Care Holdings AG, Peter Merian-Strasse 90, 4052 Basel, SWITZERLAND.
Other: Bayer Healthcare AG, Kaiser-Willhelm-Allee, Building W11, 51368 Leverkusen, GERMANY.
Accuracy Assessment | Recommendation | Basis | |
BG | Medaval | ★★★ Recommendation | Recent clinical validation; recent protocol; multiple clinical validations |
BG | MDR Criteria | Self-measurement | Published evidence |
Bailey TS, Wallace JF, Pardo S, Warchal-Windham ME, Harrison B, Morin R, Christiansen M. Accuracy and User Performance Evaluation of a New, Wireless-enabled Blood Glucose Monitoring System That Links to a Smart Mobile Device. J Diabetes Sci Technol. 2017 Jul;11(4):736-43. Epub: 2017 Feb 01. doi: 10.1177/1932296816680829. PMID: 28617617.
15197:2013 - Pass General population
Freckmann G, Jendrike N, Baumstark A, Pleus S, Liebing C, Haug C. User Performance Evaluation of Four Blood Glucose Monitoring Systems Applying ISO 15197:2013 Accuracy Criteria and Calculation of Insulin Dosing Errors. Diabetes Ther. 2018 Apr;9(2):683-97. Epub: 2018 Mar 3. doi: 10.1007/s13300-018-0392-6. PMID: 29502304. Available from: PMC6104257.
15197:2013 - Pass Lay users
15197:2013 - Pass Study personnel
Rutschmann M. Analysis of "Accuracy and User Performance Evaluation of a New, Wireless-Enabled Blood Glucose Monitoring System That Links to a Smart Mobile Device". J Diabetes Sci Technol. 2017 Jul;11(4):744-5. Epub: 2017 Feb 1. doi: 10.1177/1932296817691306. PMID: 28616932. Available from: PMC5588833.
The publication is a letter or correspondence in which the Ascensia Contour Plus ONE is referenced.
See: J Diabetes Sci Technol. 2017 Jul;11(4):736-743.