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The Financial Impact of Inaccurate Blood Glucose Monitoring Systems.

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.

SUBMITTER: Fortwaengler K

PROVIDER: S-EPMC5851223 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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The Financial Impact of Inaccurate Blood Glucose Monitoring Systems.

Fortwaengler Kurt K Campos-Náñez Enrique E Parkin Christopher G CG Breton Marc D MD

Journal of diabetes science and technology 20170926 2

<h4>Objective</h4>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.<h4>Methods</h4>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 sub ...[more]

PMID: 28946757

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Project description:BACKGROUND:Continuous glucose monitorings (CGMs) have been used to manage diabetes with reasonable glucose control amongst patients with type 2 diabetes (T2D) in recent decades. CGMs measure interstitial fluid glucose levels to provide information about glucose levels, which identify fluctuation that would not have been identified with conventional self-monitoring. Self-monitoring of blood glucose (SMBG) is a classical tool to measure glycaemic changes. However, the effectiveness of glucose control, hypoglycemia, weight change, quality of life and user satisfaction, are needed to evaluate and compare CGMs and SMBG amongst adults with T2D. METHODS:The review will compare the various forms of CGM systems (i.e flash CGM, real-time CGM, retrospective CGM) versus SMBG or usual intervention regarding diabetes management amongst adults with T2D. The following databases will be searched: Cochrane Library, PubMed, EMBASE, CINAHL, PsycINFO, Scopus and grey literature (ClinicalTrials.gov, PsycEXTRA, ProQuest Dissertations, Google Scholar and Theses Global) for the identification of studies. The studies involving adults (aged ? 18?years old) will be included. We will only include and summarise randomised clinical trials (RCTs) with respect to authors, publication type, year, status and type of devices. Studies published in English between February 2010 and March 2020, will be included as the field of CGMs amongst T2D patients has emerged over the last decade. Primary outcomes will be HbA1c (glycosylated haemoglobin level) (mmol/L), body weight (kg), time spent with hypoglycaemia (< 70?mg/dl) or hyperglycaemia (? 180?mg/dl), blood pressure (< 140/90?mmHg is considered as good management) and quality of life (understanding and feeling of living situation based on culture and value system). Secondary outcome measures will be user satisfaction (patient or treatment/intervention satisfaction or satisfaction scale) and barriers (physical and mental difficulties or issues). Study selection, data extraction and risk of bias assessment will be conducted independently by at least two reviewers. A third reviewer will determine and resolve discrepancies. Moreover, the quality of the evidence of the review will be assessed according to the Grading of Recommendations Assessment, Development and Evaluation tool (GRADE). DISCUSSION:The review will synthesise evidence on the comparison between using CGMs and SMBG. The results will support researchers and health professionals to determine the most effective methods/technologies in the overall diabetes management. SYSTEMATIC REVIEW REGISTRATION:PROSPERO CRD42020149212.

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The Financial Impact of Inaccurate Blood Glucose Monitoring Systems.

Publications

The Financial Impact of Inaccurate Blood Glucose Monitoring Systems.

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