March 22, 2010

Dear FDA

Thank you for providing the opportunity to comment on blood glucose meter accuracy. I am the father of two insulin dependant children ages 12 and 16. The younger has been on insulin for 6 years and the older 7 years. I write today from the perspective of a parent and type 1 parent’s advocate.

In the supplementary information provided to create the frame work for this discussion the FDA notes that, “Glucose meters are used by millions of people with diabetes every day. These devices have become smaller, faster, and more accurate over the past 3 decades and now allow for better glycemic control by diabetics than in the past.”

Many of those users are families of with children with type 1, insulin dependant, diabetes. Because of this insulin dependence these families are injecting insulin either with an insulin pump or with shots also know as Multiple Daily Injection. To minimize the risk of hypoglycemia these multiple daily doses of insulin must take into consideration the child’s blood sugar at the time of injection. We can only estimate or children’s blood sugar to be with in a range of plus or minus twenty percent with current meters standards.

I hope that the FDA will consider the difference between those diabetics who have this multiple daily need for actionable accuracy in the dosing insulin in addition the needs of those diabetics who do not use insulin.

What is important in this process is the glycemic control mentioned in the FDA quote above. While meters have improved over the past three decades, current standards have had the effect of halting innovation since the standards were created. The current standard of +/- 20% was defined by ISO 15197, established in 2003.

I am unaware of standards for quality assurance. I do know that variance from strip batch to batch has been reported to be an issue. Also counterfeit strips have been a cause for concern as has interference from medications.

As the FDA’s supplementary information also notes, “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.”

Every day millions of American households are treating type 1 diabetes in children with devices that were not intended or evaluated by the FDA for that use. It isn’t that we want to use meters in ways they were not evaluated or intended to be used. It is that the FDA has not evaluated meters for this use.

We have type 1 now. It needs to be managed now.

Type 1 diabetes is a 24/7 condition that is primarily managed by the individuals and families it effects. As noted above better glycimic control is achieved with multiple daily doses of insulin. While this is done in consultation with and coaching by a care team of physicians, diabetes educators, nurses and dieticians the day to day primary care management responsibility falls on the individual and family with type 1.

We would love the support of the FDA in this daily effort. Specifically by evaluation the tools we use for the use we put them to. Further the FDA should recognize that the technological progress of the past three decades didn’t stop in the early part of that past decade. We need accuracy standards that envision our daily lives, meet the actual use of our meters and progress with technology.

I hope the FDA will establish standards quality control, clear communication of accuracy standards, interference from other drugs and safeguarding the supply system from fraud.

Clear communication of accuracy standards met in meter marketing would allow consumers and their care team to select the tool based on capability. This would facilitate physicians’ ability to prescribe tools based to the degree of control and intensity of the management program they are recommending for their patients.

I hope that the FDA will be able to look back on the most this most recent decade and say that of meters, “These devices have become smaller, faster, and more accurate over the past decade and now allow for better glycemic control by diabetics than in the past.”

Tighter accuracy standards of +/- 10% would be a positive action step on that path.


Click here for the FDA and post your two bits.

FDA-2009-N-0604
Clinical Accuracy Requirements for Point of Care Blood Glucose Meters; Public Meeting; Request for Comments

5 comments:

Anonymous said...

Thanks Bennett for stating what I could not put into words, but needed to be said. I appreciate all the hard work and effort your family does for the diabetes community. And yes, a -/+10% would be greater improvement over the -/+20% we currently have. The larger percentages scare me. Especially when you are depending on your meter for accuracy. I hope the FDA will see the importance of upgrading the accuracy for all meters and strips. Thanks again! <3

Michael Hoskins said...

Bennet: Thanks for raising your voice. We all must do the same so that the FDA at least knows we're out here and that they should be listening.

Bennet said...

So true Michael. I encorage everyone to head over and make a comment. I have added link to the post (I'm a moron I sould have done that right off.)

Washington is a town that counts votes. Comments are votes.

Anonymous said...

Nicely said.

Cary said...

Does anyone know WHY we are stuck at +/- 20%? I have been toying with this in my head, but the accuracy should logically improve over time -- not stay stagnant for decades. Is there a technical limitation of the current way we are testing blood? I'm actually quite curious.