More details on the recent FDA Hearings on the accuracy of blood glucose monitoring devices: I was surprised by the report from patient advocate Ellen Ullman on Monday, noting that patient interests seem to be grossly underrepresented, and lots of experts seem to believe that the status quo of +/- 20% error margin is all that any of us need (or can handle). Grrrrr….
See Dear FDA over at “Your Diabetes May Vary” for an earful of why the status quo is NOT OK.
Meanwhile, I was lucky to be privy to a White Paper submitted to the FDA on the topic by Accu-Check/Roche Diabetes Care. (Yes, the folks who host the Diabetes Social Media Summit, but no – this can’t be just for publicity’s sake, since the paper is not publicly published.)
In this paper, Roche makes some very smart and reasonable recommendations in six areas — things that kind of shocked me, only in the sense that they’re not in place in this industry yet:
“The standard for allowable deviation in blood glucose readings — as set by the International Standard Organization — should be strengthened in two important ways:
- by changing the breakpoint (mathematical value used to calculate averages) from 75 mg/dL to 100 mg/dL to promote a ‘balanced bias’ for BG values at both the high and low-end
- and by reducing the current allowable variation down to +/-15%
Of course, we patients are pushing for +/- 10% ourselves!
2. Interferences and System Limitation
“All manufacturers should be required to test for at least the 100 most common interferences” (such as skin oil, food residue, air temperature, etc.) that can result in faulty BG readings.
No standard currently exists for this! Also, per the paper: “The manner in which interferences are tested should be standardized.” Seems like a no-brainer, ay?
Glucose meters should be required to include “failsafes for common incidents, such as not enough blood on the strip, or expired or damaged test strips.”
The way I understand this one, it means an actual explanation on the screen rather than the cryptic ‘Error 1′ or ‘Error 3′ we get now.
“Consistent, user-friendly standards regarding product labels — similar to those found on food items, from bread to soda to cereal — should be adopted.”
This has got to be an improvement over those tiny-print package inserts we get now, which are expensive to produce and promptly discarded without being read by most of us.
5. Quality Assurance
Specific guidelines for how user complaints and ‘reportable adverse events’ for glucose meters should be handled.
No guidelines currently exist on what even constitutes a reportable event, or on manufacturing processes for blood glucose systems, according to this paper. For such a high-value industry, Yipes! is all that comes to mind…
6. Support and Education
“Standards for comprehensive product support and education should be available to support self-testing… Currently, there are no mandates for either.”
I believe the idea is to go beyond simply fielding customer phone calls about product failures, to actually teach people how to use their meters to impact their health. By golly, we need this!!
These all sound like fantastic improvements to me. Again, I can hardly get my head around the fact that this stuff hasn’t been addressed already.
As my D-blogger buddy Bennet notes, glucose meters are powerful tools to help us stay healthy. What we need now are accuracy standards that envision our daily lives, meet the actual use of our meters and progress with technology (!)