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October 22, 2016
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Accuracy and Accountability (The "Strip Safely" Post)

A big August theme in the Diabetes Online Community was the campaign for accurate test strips.

The issue is not so much the usual, "20% can mean anything". (For those of us who try to maintain in the 80-120 range, 20% of 100 means we could be, or our strips could read, 80mg/dl — borderline low, or 120 — borderline high. It's worse if the device reads 220 -- are you 176, within ADA postprandial guidelines, or 264, possibly in need of a correction?) The issue is that once the strip design passes FDA approval, there is no ongoing quality control to assure that production strips maintain even that level of accuracy.

Bennet Dunlap has been spearheading this campaign under the somewhat suggestive name, "Strip Safely".

From what has appeared on that site and elsewhere, it seems that the FDA is not all that interested in hearing from patients with diabetes. They've organized patient conversations for a number of other chronic medical conditions over the next two years, but diabetes is not one of them.

Considering how many people are currently living with diabetes, and how many more are expected to be diagnosed (or living with it UNdiagnosed) over that period of time, the activist portion of our community considers it a travesty akin to someone catapulting tons of manure in our collective faces.

I'm not so sure I agree with them. I do agree that there should one or more agencies certifying the quality and efficacy of pharmaceutical products on an ongoing basis. I vehemently oppose the idea that this should be run by, or overseen by, the government. Independent evaluation organizations — such as Good Housekeeping Research Institute is for household goods and appliances, Underwriters' Laboratories are for electrical appliances, and Consumer Reports is for independent testing and comparison — would be more efficient and cost-effective. Like the Union of Orthodox Rabbis, there should be regular reinspections, both announced and unannounced, to make sure things are still "kosher" with the products.

The problem, I think, is one of cost over quality. The more people with diabetes whose healthcare expenses are managed by (or reimbursed by) both public (Medicaid/Medicare) and private (BCBS, Aetna, etc.) insurance, the more the payors will need to cut costs to remain economically viable. There's a reason Liberty Medical and other Medicaid/Medicare fulfillment houses send off-brand meters to their patients: they're cheaper to maintain. If one reasons that one meter and test strip combo are like all the others, it doesn't make sense to spend more than is absolutely necessary.

This is not to say that all off-brand meters are of poor quality. Wavesense has been known as a secondary brand that produces high-quality products at low maintenance costs. (FWIW, Target's new "Up & Up" house brand meters are just repackaged Presto and Jazz meters.) David Mendosa has been reviewing third-party meters for years and has found some that perform better than the Big Four (OneTouch, Accu-Chek, Freestyle, Bayer). But not all of these meters have cheaper strips, and many of them don't have either a "get the meter free" program or a strip-reimbursement program.

Accuracy issues can occur even with name-brand strips. I've been sent strip recall notices by OneTouch in the past, though mostly for strip batches that had been current six months ago or more. Unless I'm testing a new meter (or transitioning to one), strips don't stay around for more than a month or two (depending on how big a batch I order at the time), so I see the recall notices as CYA instruments rather than real, timely, acknowledgements of an error in test strip manufacture or distribution.

Perhaps an independent, ongoing quality-control certification program will help assure of us of test strips that perform to their stated levels, and the rapid notification and resolution of issues with the performance of our glucometers and their test strips.

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