From 2016 article by Diatribe:
"For glucose meters used by people with diabetes at home (“over-the-counter”), the FDA
guidance specifies the following accuracy standards:
- 95% of all measured blood glucose meter values must be within 15% of the true value (a lab measurement); and
- 99% of meter values must be within 20% of the true value.
As
diaTribe noted
two years ago, this means that people with diabetes can feel confident that a blood glucose meter measurement is accurate (within 15%) at least 19 times out of 20, and within 20% of the true value 99 out of 100 times. If the true (lab-measured) glucose value is 100 mg/dl, that means the meter has to be within 15 mg/dl (85-115 mg/dl) in 95% of cases, and within 20 mg/dl (80-120 mg/dl) in 99% of cases. Studies of new meters must also include at least 350 people with diabetes, larger than previously required.
Notably, these new standards require greater hypoglycemia (low blood sugar) accuracy than the
2013 ISO standard, which is used outside the US.
Technically, a “guidance” document is a
recommendation from the FDA, but in practice, it means new blood glucose meters
will need to achieve this level of accuracy to be cleared (otherwise, there may be labeling that limits their use). That said, the new guidance will not impact meters that are already on the market. FDA’s Dr. Courtney Lias told
diaTribe that inaccurate meters in current use are definitely of concern to the FDA, though other efforts will be needed to address them.
For healthcare providers using glucose meters in facilities (“point-of-care testing”), a
separate guidance has been issued:
- 95% of meter values should be within 12% of the reference value for blood sugars over 75 mg/dl, and within 12 mg/dl for blood sugars below 75 mg/dl; and
- 98% of meter values should be within 15% of the reference value for blood sugars over 75 mg/dl, and within 15 mg/dl for blood sugars below 75 mg/dl.
These criteria are similar to other published standards, and are a bit looser than the FDA originally proposed in 2014. Most experts at the time felt the original proposal stretched beyond the limits of current technology.
It is good to see the FDA incorporate patient feedback from the 2014 guidance; it’s clear the Agency is taking meter accuracy seriously. Interestingly, the glucose meter field has seen a decline in new FDA clearances over the past few years: from a high of 61 clearances
in 2012, only 35 were cleared
in 2015, and only 17 have been cleared
in 2016 so far. These guidances will raise the bar to get a new meter to market, and we’ll be watching closely to see what impact they have on new product innovation."
