Recent Research Suggests Not All Blood Glucose Monitors Meet Standards
• People with diabetes rely on self-monitoring blood glucose monitoring systems (SMBG) to make critical decisions about how they treat their diabetes. Unfortunately, there is a growing body of evidence that suggests some SMBG systems on the market today do not consistently provide accurate results.
• Globally it has been identified that a number of systems don’t consistently meet U.S. and international accuracy standards,1,2,3 giving rise to the need for the medical community to understand, discuss, and render an opinion on this trend all, subsequently, allow for FDA to determine if additional controls or actions are warranted.
• Of the 27 SMBG systems available in the United States, more than half of them (16) do not meet ISO standards, the common gold standard for meter accuracy.
• Only three of seven SMBG systems sold in the United States consistently met ISO accuracy standards,2 and since this study was conducted, even tighter ISO standards have been adopted. (April 16, 2021)
• If a SMBG system is inaccurate and provides a false reading, it puts a patient at risk of dosing too much or too little insulin.
• If too much insulin is given, it can bring blood glucose levels down to dangerously low levels, putting the patient at risk of severe hypoglycemia and possible hospitalization.
• Recent studies indicate the reduction of SMBG system errors would significantly reduce the incidence of undetected severe hypoglycemia, therefore improving glycemic control, which would not only improve the quality of life for patients, but lead to significant cost savings.4,5,6
• FDA is committed to tightening criteria for clearance of SMBG system and it is expected this will formally occur in 2021 with the introduction of a new guidance document.
• As 510k clearance is based on the data a manufacturer submits to the agency, and there is the potential that austerity measures could affect inspections of those manufacturers that are proving to not meet ISO standards, it raises the question of whether more can and should be done.
• Because of similar concerns with accuracy, the European Association for the Study of Diabetes (EASD) recently issued a statement calling for an “urgent overhaul” of their quality standards by proposing comprehensive evaluation of SMBG devices by independent research institutions and continuous post-marketing surveillance of the SMBG systems that are already approved.7
Managing Diabetes with SMBG Systems
• For those patients living with diabetes, self-monitoring of blood glucose (SMBG) is a vital component of their care. Under a SMBG regimen, a patient uses a system (meter and test strip) to monitor his or her blood glucose levels throughout the day. The goal is to maintain regular glucose levels and reduce the chances of a hypoglycemic event, or abnormally low levels of blood sugar, a goal that is made more challenging if the technology they are using is inaccurate.
• The American Diabetes Association urges patients with diabetes to perform SMBG prior to meals and snacks, at bedtime, and before exercise when low blood glucose is likely.8
• SMBG results help guide daily decisions by patients about how much insulin to take, as well as longer term treatment decisions by physicians.
The Impact of Diabetes
• The number of people with diabetes is growing, and the implications of the condition are expanding with it. More people each year need to learn how to manage their disease to avoid complications that can be life threatening. This increasing patient population also means significant cost expansion for the health care system.
• Diabetes affects nearly 26 million Americans, with approximately 2 million new cases being diagnosed each year.9
• The prevalence of diabetes has increased by more than 82 percent since 1995, and this number is likely to double by the year 2025.8,10
• The U.S. spends approximately $245 billion annually on diabetes care with $176 billion in direct medical costs, and $69 billion in indirect costs due to disability, work loss and premature mortality.10
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Diabetes is a growing public health epidemic affecting nearly 26 million Americans, and according to the American Diabetes Association, 1.9 million new cases of diabetes are diagnosed in people aged 20 years and older each year.2