Michael Stedman1, Rustam Rea2, Christopher J Duff3,4, Mark Livingston5, Gabriela Moreno6, Roger Gadsby7, Helen Lunt8, Anthony A Fryer3,4, Adrian H Heald9,10. 1. Res Consortium, Andover, Hampshire, UK. 2. Oxford Centre for Diabetes, Endocrinology and Metabolism, Oxford, UK. 3. Department of Clinical Biochemistry, University Hospitals of North Midlands NHS Trust, Stoke-on-Trent, Staffordshire, UK. 4. School of Primary, Community and Social Care, Keele University, Stoke-on-Trent, UK. 5. Black Country Pathology Services, Walsall Manor Hospital, UK. 6. High Specialty Regional Hospital of Ixtapaluca, Mexico. 7. Warwick Medical School, University of Warwick, Coventry, UK. 8. University of Otago, Christchurch, New Zealand. 9. The School of Medicine and Manchester Academic Health Sciences Centre, University of Manchester, UK. 10. Department of Diabetes and Endocrinology, Salford Royal Hospital, UK.
Abstract
BACKGROUND: The National Health Service spends £170 million on blood glucose monitoring (BGM) strips each year and there are pressures to use cheaper less accurate strips. Technology is also being used to increase test frequency with less focus on accuracy.Previous modeling/real-world data analysis highlighted that actual blood glucose variability can be more than twice blood glucose meter reported variability (BGMV). We applied those results to the Parkes error grid to highlight potential clinical impact. METHOD: BGMV is defined as the percent of deviation from reference that contains 95% of results. Four categories were modeled: laboratory (<5%), high accuracy strips (<10%), ISO 2013 (<15%), and ISO 2003 (<20%) (includes some strips still used).The Parkes error grid model with its associated category of risk including "alter clinical decision" and "affect clinical outcomes" was used, with the profile of frequency of expected results fitted into each BGM accuracy category. RESULTS: Applying to single readings, almost all strip accuracy ranges derived in a controlled setting fell within the category: clinically accurate/no effect on outcomes areas.However modeling the possible blood glucose distribution in more detail, 30.6% of longer term results of the strips with current ISO accuracy would fall into the "alter clinical action" category. For previous ISO strips, this rose to 44.1%, and for the latest higher accuracy strips, this fell to 12.8%. CONCLUSION: There is a minimum standard of accuracy needed to ensure that clinical outcomes are not put at risk. This study highlights the potential for amplification of imprecision with less accurate BGM strips.
BACKGROUND: The National Health Service spends £170 million on blood glucose monitoring (BGM) strips each year and there are pressures to use cheaper less accurate strips. Technology is also being used to increase test frequency with less focus on accuracy.Previous modeling/real-world data analysis highlighted that actual blood glucose variability can be more than twice blood glucose meter reported variability (BGMV). We applied those results to the Parkes error grid to highlight potential clinical impact. METHOD:BGMV is defined as the percent of deviation from reference that contains 95% of results. Four categories were modeled: laboratory (<5%), high accuracy strips (<10%), ISO 2013 (<15%), and ISO 2003 (<20%) (includes some strips still used).The Parkes error grid model with its associated category of risk including "alter clinical decision" and "affect clinical outcomes" was used, with the profile of frequency of expected results fitted into each BGM accuracy category. RESULTS: Applying to single readings, almost all strip accuracy ranges derived in a controlled setting fell within the category: clinically accurate/no effect on outcomes areas.However modeling the possible blood glucose distribution in more detail, 30.6% of longer term results of the strips with current ISO accuracy would fall into the "alter clinical action" category. For previous ISO strips, this rose to 44.1%, and for the latest higher accuracy strips, this fell to 12.8%. CONCLUSION: There is a minimum standard of accuracy needed to ensure that clinical outcomes are not put at risk. This study highlights the potential for amplification of imprecision with less accurate BGM strips.
Authors: A H Heald; M Livingston; A Fryer; G Y C Moreno; N Malipatil; R Gadsby; W Ollier; M Lunt; M Stedman; R J Young Journal: Diabet Med Date: 2018-01 Impact factor: 4.359
Authors: Adrian H Heald; Mark Livingston; Anthony Fryer; Gabriela Cortes; Simon G Anderson; Roger Gadsby; Ian Laing; Mark Lunt; Robert J Young; Mike Stedman Journal: Int J Clin Pract Date: 2018-08-31 Impact factor: 2.503
Authors: Mike Stedman; Rustam Rea; Christopher J Duff; Mark Livingston; Stephen Brown; Katherine Grady; Katie McLoughlin; Roger Gadsby; Angela Paisley; Anthony A Fryer; Adrian H Heald Journal: J Diabetes Sci Technol Date: 2020-07-05
Authors: Mike Stedman; Rustam Rea; Christopher J Duff; Mark Livingston; Katie McLoughlin; Louise Wong; Stephen Brown; Katherine Grady; Roger Gadsby; John M Gibson; Angela Paisley; Anthony A Fryer; Adrian H Heald Journal: Endocrinol Diabetes Metab Date: 2021-12-17