References

1. Christiansen, M. et al. A New, Wireless-enabled Blood Glucose Monitoring System That Links to a Smart Mobile Device: Accuracy and User Performance Evaluation. Journal of Diabetes Science and Technology. 2017, Vol. 11(3) 567-573.

2. Bernstein, et al. A New Test Strip Technology Platform for Self-Monitoring of Blood Glucose. J Diabetes Sci Technol 2013; 7(5): 1386-1399.

3. Ascensia Diabetes Care, Data on file. SMARTSON market research study of the CONTOUR^®NEXT ONE meter and the CONTOUR^®DIABETES app, June 2017, Sweden. Participants received free meter and test strips.

4. International Organization for Standardization. In vitro diagnostic test systems – requirements for blood-glucose monitoring  systems for self-testing in managing diabetes mellitus (ISO 15197). Geneva,  Switzerland, 2013.

5. Harrison B and Brown D. Performance and accuracy capability of a new, wireless-enabled blood glucose monitoring system that links to a smart mobile device: laboratory and clinical sample reapplication studies. Poster presented at 10th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD); February 15-18, 2017.

6. CONTOUR^®NEXT ONE BGMS User Guide. Revised January 2017.

*Results from an ad hoc analysis of the CONTOUR^®NEXT ONE system demonstrated that 95% of the total results were within ±8.4 mg/dL  or ±8.4% of the YSI reference glucose values (YSI Life Sciences, Inc., Yellow Springs, OH) for subject-obtained capillary  fingertip results from subjects with diabetes for samples with glucose concentrations <100 mg/dLand ≥100 mg/dL, respectively.

^† 95% of the measured glucose values shall fall within either ±15 mg/dL of the average measured values of the reference  measurement procedure at glucose concentrations <100 mg/dL or within ±15% at glucose concentrations ≥100 mg/dL<sup>4

§</sup> ISO 15197:2013 accuracy standards allow an error margin of ±15 mg/dL at glucose concentrations <100 mg/dL or ±15% at glucose concentrations ≥100 mg/dL .⁴