Abstract

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.

Highlights

  • There is a clear relationship between blood glucose monitoring (BGM) system accuracy and cost, with the highest costs being associated with BGM systems not meeting the ISO 15197:2003 standard

  • When utilized within a structured testing regimen, self-monitoring of blood glucose (SMBG) provides information about patients’ current glycemic status and the ability to obtain immediate feedback regarding the impact of behavioral and pharmacological interventions on glucose levels. Because both clinicians and patients utilize SMBG data to make critical decisions regarding diabetes medication adjustments, it is crucial that glucose results are accurate

  • Compared to an “ideal” system with no anticipated system inaccuracy, the average additional cost of inaccuracy associated with the entire group of BGM systems was £155 per patient year (PPY) (£95 to £219, depending on population)

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Summary

Methods

The study included 43 BGM systems previously assessed for accuracy according to ISO 15197:2003 and ISO 15197:2013 criteria. The approach can be used with mixed populations of both T1DM and insulin-treated T2DM patients, regardless of age, gender and other demographic parameters. It is not appropriate for use in very special populations (eg, pediatric, gestational) or single individuals. We utilized findings from a recent study by CamposNáñez and colleagues, who used the UVA/PADOVA Type 1 Diabetes Simulator to assess the effect of BGM system accuracy on clinical outcomes, including changes in HbA1c, SHE, insulin utilization, and SMBG frequency.[21].

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