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Thanks to Larry Ellingson for sharing this: 

RESOLUTION ON THE IMPORTANCE OF NEED TO DEVELOP MORE STRINGENT ACCURACY REQUIREMENTS FOR BLOOD GLUCOSE MONITORING SYSTEMS

WHEREAS, the American Diabetes Association estimated in 2011 that 25.8 million children and adults in the United States have diabetes,1 and

WHEREAS, the prevalence of diabetes has increased by 82.2% since 1995 in the United States,1 with the prevalence of diabetes likely to double by 2025,2 and

WHEREAS, the American Diabetes Association estimated in 2013 that the total estimated costs of diagnosed diabetes have increased 41% from $174 billion in 2007 to $245 billion in 2012,2 and

WHEREAS, the American Diabetes Association recommends that diabetes patients on multiple-dose insulin (MDI) or insulin pump therapy should perform self-monitoring of blood glucose (SMBG) at least prior to meals and snacks, occasionally postprandially, at bedtime, prior to exercise, when they suspect low blood glucose, after treating low blood glucose until they are normo-glycemic, and prior to critical tasks such as driving,1 and

WHEREAS, when prescribed as part of a broader educational context, SMBG results may be helpful to guide treatment decisions and/or patient self-management for patients using less frequent insulin injections or noninsulin therapies,1,3 and

WHEREAS, hypoglycemia requiring emergency assistance from health service personnel is as common in people with type 2 diabetes treated with insulin as in people with type 1 diabetes,4 and

WHEREAS, the risk of severe or fatal hypoglycemia associated with the use of oral agents or insulin increases exponentially with age,5,6 and

WHEREAS, inaccurate glucose readings due to low hematocrit can have significant clinical implications for patients with renal disease,7 by potentially masking hypoglycemia, which is of great concern among elderly diabetic patients with chronic kidney disease in whom the risk of severe or fatal hypoglycemia associated with the use of oral agents or insulin increases exponentially with age,8,9 and

WHEREAS, inaccurate SMBG results bear the risk of wrong therapy decisions (e.g., inappropriate adjustments to the insulin dose or inappropriate intake of carbohydrates), which can lead to serious health injuries and mortality,10 and

WHEREAS, recent studies have demonstrated that up to more than 45% of SMBG systems being marketed globally to patients with diabetes do not meet the minimum accuracy requirements as defined in the ISO DIN EN ISO 15197 standard, showing significant lot-to-lot variability in independent laboratory evaluations,11-13 and

WHEREAS, current U.S. Food and Drug Administration (FDA) approval criteria for SMBG systems do not require lot-to-lot testing and/or reporting of data to be included in submission documents,14 and

WHEREAS, many of the manufacturers of the SMBG systems studies provide no or inadequate medical device reporting (MDR) of adverse events associated with the use of their systems according to U.S. Food and Drug Administration (FDA) requirements,15

WHEREAS, recent studies have shown that reduction of SMBG system errors can significantly reduce the incidence of undetected severe hypoglycemia (

WHEREAS, reduction of the above mentioned complications can lead to significant cost savings and improved patient quality of life,17,18 and

WHEREAS, because of similar concerns with accuracy and safety, the European Association for the Study of Diabetes (EASD) has recently called for an urgent overhaul of the current Conformité Européanne(CE) marking procedure for the evaluation and approval of SMBG systems and other medical devices, proposing comprehensive evaluation of such devices by independent research institutions (including in-vitro and real-life studies) and continuous post-marketing surveillance of the SMBG systems that are approved,19 and

NOW, THEREFORE BE IT RESOLVED, that the NATIONAL DIABETES VOLUNTEER LEADERSHIP COUNCIL supports and encourages the FDA to critically review its current criteria for approval of SMBG systems and require more comprehensive testing of the accuracy and precision of these systems by independent laboratories/institutions and continuously monitor the accuracy/precision of these systems once they are in the market, and

BE IT FURTHER RESOLVED, that these new FDA criteria be applied retroactively to include all SMBG systems currently marketed in the US in order to better ensure patient safety, facilitate improved long-term glycemic control and help reduce the financial burden of diabetes.

National Diabetes Volunteer Leadership Council

Larry Ellingson
Chair of the Board 2005
American Diabetes Association

Larry Smith
Chair of the Board 2006
American Diabetes Association

Stewart Perry
Chair of the Board 2008
American Diabetes Association

George Huntley
Chair of the Board 2009
American Diabetes Association References

1. Standards of medical care in diabetes–2013. Diabetes Care. 2013;36 Suppl 1:S11-66

2. Economic costs of diabetes in the U.S. In 2012. Diabetes Care. 2013;36:1033-1046

3. Polonsky WH, Fisher L, Schikman CH, Hinnen DA, Parkin CG, Jelsovsky Z, Petersen B, Schweitzer M, Wagner RS. Structured self-monitoring of blood glucose significantly reduces A1c levels in poorly controlled, noninsulin-treated type 2 diabetes: Results from the structured testing program study. Diabetes Care. 2011;34:262-267

4. Leese GP, Wang J, Broomhall J, Kelly P, Marsden A, Morrison W, Frier BM, Morris AD, DARTS/MEMO Collaboration.Frequency of severe hypoglycemia requiring emergency treatment in type 1 and type 2 diabetes: a population-based study of health service resource use. Diabetes Care. 2003 Apr;26(4):1176-80.

5. Meneilly GS, Cheung E, Tuokko H. Counterregulatory hormone responses to hypoglycemia in the elderly patient with diabetes. Diabetes. 1994;43:403-410

6. Meneilly GS, Tessier D. Diabetes in the elderly. Diabet Med. 1995;12:949-960

7. Besarab A, Bolton WK, Browne JK, Egrie JC, Nissenson AR, Okamoto DM et al. The effects of normal as compared with low hematocrit values in patients with cardiac disease who are receiving hemodialysis and epoetin. N Engl J Med. 1998;339:584-590

8. Meneilly GS, Cheung E, Tuokko H. Counterregulatory hormone responses to hypoglycemia in the elderly patient with diabetes. Diabetes. 1994;43:403-410

9. Meneilly GS, Tessier D. Diabetes in the elderly. Diabet Med. 1995;12:949-996

10. Clarke WL. The original Clarke Error Grid Analysis (EGA). Diabetes Technol Ther 2005;7:776-779

11. Freckmann G, Baumstark A, Jendrike N, Zschornack E, Kocher S, Tshiananga J, Heister F, Haug, C. System accuracy evaluation of 27 blood glucose monitoring systems according to DIN EN ISO 15197. Diabetes Technol Ther. 2010;12(3):221-231

12. Brazg RL, Klaff LJ, Parkin CG. Performance variability of seven commonly used self-monitoring of blood glucose systems: clinical considerations for patients and providers. J Diabetes Sci Technol. 2013;7(1):144-152

13. Baumstark A, Pleus S, Schmid C, Link M, Haug C, Freckmann G. Lot-to-lot variability of test strips and accuracy assessment of systems for self-monitoring of blood glucose according to ISO 15197. J Diabetes Sci Technol. 2012;6(5):1076-1086

14. US Food and Drug Administration. Review Criteria Assessment of Portable Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology. Accessed March 20, 2013, from http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094134.htm

15. US Food and Drug Administration. Medical device reporting for manufacturers. Accessed March 20, 2013, from http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094529.htm

16. Breten MD, Kovatchev BP. Impact of blood glucose self-monitoring errors on glycemic variability, risk for hypoglycemia, and average glucose control in type 1 diabetes: an in silico study. J Diabetes Sci Tech 2010;4(3)563-570

17. Fitch K, Iwasaki K, Pyenson B. Improved management can help reduce the economic burden of type 2 diabetes: a 20-year actuarial project. Millman Client Report, April 28, 2010

18. Aagren M, Luo W. Association between glycemic control and short-term healthcare costs among commercially insured diabetes patients in the United States. J Med Economics. 2011;4(1):108-114.

19. European Association for the Study of Diabetes. Medical Devices in Diabetes Care: A statement on behalf of the European Association for the Study of Diabetes. Accessed March 20, 2013, from http://87.234.226.93/easdintranet/easdwebfiles/statements/Medical_Devices_Statement.pdf

Bennet Dunlap

One Comment

  1. Jodee Martin

    Touché to the volunteer counsel. We need mnay efforts like this to protect our children’s rights.
    I was astounded by Oxford’s requirement that we switch to a less accurate and more demanding meter.
    Thanks you for
    Fighting the fight on behalf of all of us.

    Reply

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