Page 71 - Glucose Monitoring Devices

An extended illustration 69

Observations from the illustrative example
Based on our approach, we showed that there is a clear relationship between BGM
system accuracy and clinical outcomes, with the highest costs being associated with
meter systems not meeting the ISO 15197:2003 standard. Our analysis makes it clear
that BGM systems compliant with the ISO 15197:2013 standard have a limited
effect on HbA1c, severe hypoglycemia incidence, total daily insulin, and fingerstick
frequency. For the top 50% BGM systems complying with ISO 15197:2013, the
worst observed effect on the HbA1c values was 0.12% (absolute) while the worst
increase in SHE cases could reach 0.36 cases PPY. Compare this to the results for
the group of BGM systems, not compliant with any ISO standard: for the HbA1c
values, the increases could reach approximately 0.47% while the number of annual
SHE could increase by up to 1.70 cases per year (it is important to understand that
the system leading to an increase in HbA1c of 0.47% is not the same as the one
increasing the SHE by 1.70 cases PPY!). In addition, insulin consumption could
increase by up to 5.5 units/day and the number of fingersticks by up to 1.0 tests/day.
Lower costs are associated with systems meeting the ISO 15197:2013 standard.
Using BGM systems that meet the system accuracy criteria of the ISO 15197:2013
standard can help reduce the clinical and financial consequences associated with the
inaccuracy of BGM devices. The worst-case analysis shows that compliance with
stricter accuracy standards reduces clinical and financial risk for patients and
healthcare systems.
Bias is the accuracy characteristic that has the biggest influence on HbA1c, and
both BGM system error and bias have a significant effect on the incidence of severe
hypoglycemia.

Average Additional Cost Worst-Case Additional Cost
Lower Upper Lower Upper
50% 50% 50% 50%

£79 £64 Compliant ISO 15197:2013 £278 £145 Compliant ISO 15197:2013

£306 £597

£216 Compliant Not £440 Compliant Not

Not ISO 15197:2003 Not ISO 15197:2003
Compliant Compliant Compliant Compliant
FIGURE 4.12
Costs associated with compliance with ISO standards of accuracy [34].