Objective: An in silico study of type 1 diabetes (T1DM) patients utilized the UVA-PADOVA Type 1 Diabetes Simulator to assess the effect of patient blood glucose monitoring (BGM) system accuracy on clinical outcomes. We applied these findings to assess the financial impact of BGM system inaccuracy.
Methods: The study included 43 BGM systems previously assessed for accuracy according to ISO 15197:2003 and ISO 15197:2013 criteria. Glycemic responses for the 100 in silico adult T1DM subjects were generated, using each meter. Changes in estimated HbA1c, severe hypoglycemic events, and health care resource utilization were computed for each simulation. The HbA1c Translator modeling approach was used to calculate the financial impact of these changes.
Results: The average cost of inaccuracy associated with the entire group of BGM systems was £155 per patient year (PPY). The average additional cost of BGM systems not meeting the ISO 15197:2003 standard was an estimated £178 PPY more than an average system that fulfills the standard and an estimated £235 PPY more than an average system that appears to meet the ISO 15197:2013 standard.
Conclusion: There is a clear relationship between BGM system accuracy and cost, with the highest costs being associated with BGM systems not meeting the ISO 15197:2003 standard. Lower costs are associated with systems meeting the ISO 15197:2013 system accuracy criteria. 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 inaccuracy of BGM devices.
Keywords: BGM; HbA1c; SMBG; accuracy; clinical impact; cost; diabetes; economic impact; hypoglycemia; in silico; inaccuracy; insulin.