Thought for the Day

Saturday, March 20, 2010

Glucose Meter Accuracy and the FDA

A topic that many diabetic bloggers have weighed in on recently is the fact that the FDA is planning a public discussion of "the clinical accuracy requirements of blood glucose meters...." The hope among many diabetics is that the FDA will decide to require greater accuracy from these devices. Currently, they are allowed to be within plus or minus 20 percent of a clinical blood test.

If you have an opinion, you have until April 10 to tell the FDA here.

Here are some of my thoughts on the issue.
The FDA, in its notice of this public meeting, explains:

Blood glucose meters are being used in clinical settings and at home in ways that are not within the intended use of the devices as evaluated by FDA. For example, glucose meters are increasingly being used to achieve tight glycemic control despite the fact that these devices have not been cleared for this use.

Excuse me, but that just doesn't cut it. The American Association of Clinical Endocrinologists (AACE) recommends that diabetics have a target A1c of 6.5, with a target blood glucose level of less than 110.
If the FDA rationalization above is relevant, then we can ignore the target blood glucose, because we don't have anything to test blood glucose with, not if we're trying to adhere to these guidelines. According to the FDA, it is not the intended use of our blood glucose meters to keep our blood sugars that tightly controlled.
Of course, if these meters aren't intended for this purpose, then we are missing a key piece in the diabetes management system.
Reading any reference on diabetes management, consulting with any manual on how to use an insulin pump, an insulin pen, or a CGM will show repeatedly that we require accurate meters to do what doctors, CDEs, and medical device manufacturers are telling us to do.
Whether or not the FDA and the meter industry want to concede the point, these meters are for "tight glycemic control."

To determine how accurate the meters should be, I suggest they look at how accurate the dosing of insulin is.
Look at the lines on the side of a 1/3 cc insulin syringe, or the increments on an insulin pen. Consider the insulin pumps with increments of 0.025 units of insulin.
Blood glucose meters should approach this level of accuracy, or something is out of whack.
If it's OK for my blood sugar reading to be 30 points off, why should my pump be able to deliver increments of less than half a unit?

Indeed, why am I not still just peeing on a color-changing strip and taking one shot of long-acting insulin a day?

To see some other blogs on this topic:

Scott's Blog - Tell the FDA +/- 20% Is Not "Good Enough" Today

Diabetesaliciousness(tm) - Meters = Diabetes GPS System!

Six Until Me - Accuracy in Glucose Meters

Your Diabetes May Vary - What is Accuracy?

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