March 20, 2010

Ellen on Meter Accuracy

Good Friend of the Blog Ellen Ullman wrote this as a comment on accuracy but I upgraded it to a Guest Post:

I want significantly improved accuracy for all meters for all persons with diabetes.

It is not only the 20% inaccuracy that is permitted which I find UNacceptable, but perhaps even more so that it only has to be within that 20% above 75 mg/dl 95% of the time - NINETY-FIVE PERCENT OF THE TIME. The other 5% are considered "outliers" without explanation. To hear some in industry or academia discuss it, it felt to me as if outliers are considered nothing more than dots outside of the Clarke Error Grid A/B Zone. But I view the very same dots as flashing warning signs with alarms going off - CAUTION - because of the potential human consequences that may result from that # on the meter.

Some of us are very in tune with our bodies or our children's bodies and know enough not to dose based on a reading that seems so far beyond what we think may really be going on in the body. NOT every person with diabetes, and not every caregiver of a loved one with diabetes, has that intuition, or perhaps has ever had the education to know not to dose without checking again. Many of us are fortunate to have extra test strips to use when we question a number on a meter that doesn't seem congruent with the situation. Some people barely can afford a single test strip let alone 2-3 extra to figure out what the approximate bg value is. So what happens to the 2 yr old whose parents are underinsured, less well educated, or given the cheapest and least accurate meter on the market and the meter says, for example, 350 mg/dl prior to a meal and they give a whopping dose of insulin to correct for the 350 that had they rechecked would have discovered bg was closer to 120 mg/dl? Every single outlier is a potential disaster. It only took the memory of one seizure requiring glucagon injection in my toddler in 1989 or 1990 and the thought of how many have occurred and how many in the future may occur due to meter inaccuracy and excused outliers - to know I needed to stand up before FDA/CDRH and plead for the need for increased accuracy and the ability to compare meters based on performance accuracy. We need to eliminate every possible variable that we can in our daily journey of the diabetes roller coaster ride and tightrope walk. AND we are calibrating our CGMs based on these meters that require less than adequate precision and accuracy - what if your calibration is based on an outlier?

(Are you having Cheerios for breakfast? LOL )

Nope Ellen Just coffee. Cheerios are too hard to cook without coffee. ;)