Like many people with diabetes, I am frustrated by inaccurate readings from my blood glucose meters. The FDA requires that 95% of our meter readings above 75 mg/dl be within +/- 20% of the actual blood glucose value. Below 75 mg/dl 95% of the readings must be within +/- 15 points of the actual value. That means that my meter reading of 200 could actually be 160 or 240 and be considered accurate. Or my 60 could be a 45 or 75. When you base your insulin doses on these numbers, it’s a scary proposition.
I have learned from the Strip Safely website that the FDA standards are only part of the problem. Currently there is no further testing by the FDA once a meter and strips are on the market. At the Diabetes Technology Society’s May conference, studies were presented showing that there are many BG systems on the market that do not meet current standards and that some are as much as 40% high or low. That 200 meter reading can now be anything from 120-280. Most of the non-compliant meters and strips are manufactured outside the USA and the FDA has trouble monitoring these companies.
It was suggested at this meeting that the CMS (Centers for Medicare & Medicaid Services) bidding process is creating an atmosphere where price alone is determining what will be available. Quality is being sacrificed and patients are being put at risk. If you want to see one of those patients at risk, look in the mirror. I am close to Medicare age and I am terrified. Because Medicare standards influence most insurance company decisions, everyone of any age is affected by this.
Bennet Dunlap of the YDMV blog is the driving force behind the Strip Safely campaign. Only Bennet could have thought of such a titillating name:) He is encouraging each of us to visit the website, take the quiz, and learn about the campaign. Then we should follow through and write letters to our senators and representatives as well as members of the FDA. There are instructions about how to do this on the website and many sample letters. If you would like to listen to Bennet discussing the Strip Safely campaign, check out the 7/1/13 DSMA ‘Rents show.
I spent the 4th of July writing letters to my senators, my representative, and the FDA. I can’t think of a better way to have spent our national holiday than by exercising my right to influence my elected representatives. The models for my letters were from the Strip Safely website along with Meri’s letter at Our Diabetic Life. I wrote a longer letter to the FDA and if you would like a copy of it, please contact me through the link in my blog menu. The one page letter to my elected reps is below. This is the first time that I have ever written letters like this. If I can do it, so can you!
My Sample Letter (please copy if you’d like):
I have had Type 1 diabetes since 1976. I use an insulin pump to deliver the exogenous insulin that I cannot live without. I test my blood sugar levels about ten times per day and this testing is a critical part of my diabetes care. I need accurate meters and test strips to enable me to determine the correct amount of insulin required for meals, snacks, and corrections. Inaccurate strips lead to inaccurate insulin dosages that can impact my short-term and long-term health with resulting blood glucose highs and lows. Severe lows can be life-threatening.
The diabetes community in the United States needs your help. Please help keep inaccurate meters out of the hands and off the fingers of people with diabetes. At a recent meeting with the Diabetes Technology Society, the FDA acknowledged that there is a problem with test strips by certain manufacturers not delivering the level of accuracy for which they were approved. Many of these manufacturers are from Asia and other offshore locations. The FDA does not currently have a plan to do anything about the problem.
We need them to have one. Please use your office to help keep Americans with diabetes safe.
Type 1 Diabetes is characterized by incredible variability and inaccurate strips make a difficult disease even more difficult to manage. Please ask the FDA to implement a post-market program of ongoing random sampling of strips to insure that all brands consistently deliver the accuracy in the real world that they were approved to do.
We would also love to see the accuracy standard in the USA tightened to match the ISO standard of 15%. But first things first. Currently a lack of post-market quality control over manufacturers by the FDA degrades the existing standards to irrelevance.
The FDA has many responsibilities. Please make Fixing Diabetes Testing Accuracy one of the things for which the FDA is known.
Very truly yours,