Moo. Moo. Moo.

Shaggy Highland cows are the best. The. Best.
Shaggy Highland cows are the best. The. Best.

Cows are loud when they moo in unison. Unplugged death metal loud. I love their silly little faces and their big tongues that loll out of their mouth when they’re happily eating. (See: any cute animal.)

I miss them. I want them to come home, but until they do, I’m going to rehash the importance of mooing in unison to the FDA.

See, we only have a few cows mooing about blood glucose meter accuracy, and that makes me sad confused frustrated mooing at deafening decibels in the hopes that you will bring it home.

What the hell am I talking about? (“Is she talking about cows? Huh?”)

Last week, I brought to your attention the need for anyone who is, knows, loves, or might know in the future a person with diabetes. The Food & Drug Administration (FDA) has graciously opened its ears to let us have our say about their proposed changes to the recommendations about blood glucose accuracy.

I’m going to be blunt. (Please try to control your shock.)

Do you not care about blood glucose meter accuracy?

Some of you do. To date, 67 individuals have comments on the Over The Counter Use docket and 16 individuals have comments on the Point of Care docket. (So, besides me, 66 and 15.)

That’s bloody miserable. 

How many people with diabetes live in the United States? Over 26 million. (Even with my subpar math skills, I know that 26 million is more than 67.) Of those, more than 3 million are Type 1. (Again, that math thing. 3 million > 67…)

More than 67 people read this blog. More than 67 people read Bennet’s blog. More than 67 people read A Sweet Life.

So, what’s the deal?

Is it not important enough?

Is it not sexy enough?

Miss Manner’s little gaffe ignited a firestorm of responses and comments, but this – having a piece of technology that we rely on for treatment decisions that could send us to the ER or the morgue if it’s wrong – this isn’t something that warrants a comment?

I’m confused. Is there just not enough time in the day to copy and paste? I know, I know… The Internet is filled with very important things like cats and pictures of young James Spader (meow) and someone has to respond to a friend’s status update on Facebook. Or post a video of a cat and a dog snuggling. I get that.

Is blood glucose meter accuracy not as cute? For sure. It’s not cute. It’s not cute at all. Not like cows and kittens and doggies.

Was I not clear enough? Didn’t I explain how easy it was? Did I not speak loudly? Did I not enunciate? E-nun-ci-ate?

I’d love to understand why it doesn’t matter to everyone. Those who have diabetes who might end up on the wrong end of an inaccurate meter because it just didn’t matter enough to comment. Those who pay into the medical system and balk at the thousands of dollars needlessly spent on emergency situations because it just didn’t matter enough to comment?

Every. Comment. Matters. 

Your voice matters. Even if it’s not your own words. The more mooing to the FDA, the more important it becomes in D.C… I know.

So, once again, I’m going to moo on this until April 7th – that’s when the cows come home.

Here are the steps – it’s as simple as I can make it for every U.S. citizen. You don’t even need to leave your name on the comment. Not required.

1. Look at the clock. Then copy the info below from “Progress to Conclusion”:

Progress

I find many encouraging ideas in the FDA’s draft guidance. Its tighter accuracy standards (particularly in the hypoglycemic range) are a huge step forward. The new emphasis on test strip lot release criteria will hopefully lead to better quality control, and the proposed requirement for front-of-package accuracy information will make clear that the quality of blood glucose meters varies, and allow users to make informed choices.

Suggestions:

Clarity

The terms “over-the-counter-use” and “prescription point-of-care” use are confusing. Instead, “for patient personal use” and “for professional in clinic use” would make the distinction clearer.

Accuracy

Insulin is a very dangerous drug. Reports show insulin to be a leading cause of adverse drug reaction emergency room admissions.* Insulin is dosed based on meter readings. People with diabetes have a real need for accuracy in our lives, outside the hospital to preventing the adverse insulin reactions that cause ER admissions. Both the patent self use and the caregiver in office use meters should have the same mandated level of accuracy. Dr. David Sacks of NIH suggests the proposed professional standards may not be possible at this time.# Accuracy should be required at the highest level that is economically feasible.

*drugs.com/news/adverse-reactions-new-national-perspective-risk-1954.html

#Close Concerns. 2014-2-27

Post-Market

Currently there is no program in place to review devices to ensure they continue to maintain the accuracy for which they were approved. This allows quality to slip over time, and puts patient health at risk. There should be a post-market surveillance programwith the ability to remove unqualified meters from the market.

MDR

There is a wide discrepancy between manufacturers in the number of Medical Device Reports (MDR) that they file.* This is problematic since, as the FDA has stressed, MDRs are essential for the post-market evaluation of glucose meters; failure to comply with MDR requirements puts patient lives at risk. This guidance should require criteria for robust MDR policies, similar to the proposed lot release criteria, in order for a meter to be cleared.

* Close Concerns. 2013-5-27

Dose Insulin

The FDA stated in a December 2013 clearance document that “Blood Glucose Meter Accuracy is the most important criteria in determining glucose meter quality.” It also indicated in that document that the 2003 accuracy standards (which this guidance would replace) may not be sufficient, because it required the meter in question — which met the 2003 requirements — to be sold with the following all-cap warning:  “DO NOT USE [the meter] TO CALCULATE INSULIN DOSES. DO NOT USE [it] TO CALIBRATE CONTINUOUS GLUCOSE MONITORS.”* The new guidance should make clear that only devices which meet the tighter standards can be cleared by FDA to dose insulin or calibrate continuous monitors (and thus be considered DME).

* accessdata.fda.gov/cdrh_docs/reviews/K122340.pdf

DME

The FDA must also be clear that meters that do not meet the new accuracy requirements should not be considered “durable medical equipment.”

The guidance should explicitly state that the only blood glucose meters that can be considered “durable medical equipment” by payers are those that the FDA determines can be used to “make therapy adjustments” — meaning that they’re accurate enough to calculate insulin doses or to calibrate a CGM. Any meter that does not meet the necessary level of quality (and maintain it post-market) cannot be considered DME, and therefore should not be considered eligible for Medicare/health or private insurance reimbursement as DME for diabetes. (The quoted language comes directly from CMS.)

Therapy Adjustments

The proposed labeling requirements should specifically state whether a meter has received FDA clearance to “make therapy adjustments” — a statement that could only be made if the meter and its strips met, and continued to meet, these proposed new accuracy standards. Again, this phrasing would clearly distinguish which meters should be eligible for insurance coverage, since only those that are accurate enough to be used for therapy adjustments should qualify.

Conclusion:

The proposed new standards are a positive step, but they can only be effective if they are accompanied by specific quality and labeling requirements that prevent third-party payers from limiting coverage to antiquated meters, and meter/test strip manufacturers from dragging their heels. These proposed changes, when combined with a post-market surveillance system and enforcement policy, will help ensure that I and all people with diabetes are able to safely manage our disease.

2. Click on the link below and paste the stuff you’ve just copied.

http://www.regulations.gov/#!submitComment;D=FDA-2013-D-1446-0002

3. Click on the link below and paste the stuff you’ve just copied again.

http://www.regulations.gov/#!submitComment;D=FDA-2013-D-1445-0001

4. Look at the clock. Two minutes? Three minutes?

I’m sorry that it may have taken you away from Facebook or TMZ, but I’m glad you took a few minutes from your life to help save mine and others in the future.

Please moo with me. Please see that while this isn’t sexy or cute, it’s so very necessary. It doesn’t matter if you have diabetes. It will impact you. You know someone with diabetes. You want that person to live well, right? I’m a firm believer in the adage of “If you’re not part of the solution, you’re part of the problem…” Be a part of the solution with us.

Please…

Moo.

 

 

"Do it. Do. It. DO IT!!!"

I am quoting my daughter when she wants me to complete something for her: opening a jar, getting art supplies off the top shelf, or putting tofu and ketchup on a plate for lunch. (The Kid has some eclectic food combinations.)

But today, I’m saying this to you. Two minutes of your day can help all of those with diabetes. How?

This:

Keep Test Strips Available              View in browser
[TURN IMAGES ON: StripSafely - Accurate Diabetes Testing Matters. Please Turn Images On.]
Got two minutes to help shape the future of accurate diabetes testing? 

 

FDA is looking for comments about new draft glucose meter rules in two open dockets. Open dockets are a unique opportunity where the FDA is focused on listening to the public – we need them to hear us. 

The current rules for glucose meters are from 2003. It may be another decade before FDA asks for public comment on meter rules.
We have until April 7th.

 

DC is a town where the number of messages matters. Many comments, even if they are repetitive, will help the diabetes community be heard.

Other interests will lobby for their views. We must speak up for our views. Our health. Our lives. 

 

How can you help?
We’ve made it easy with sample comments, a step-by-step guide to commenting to a FDA docket, and additional guidance information. 

1. Review the sample comments here:http://www.stripsafely.com/sample-page/guidance/

2. Use the step-by-step guide to post comments to the dockets:http://www.stripsafely.com/sample-page/comment2fda/

3. Share this email with everyone you know.
Twitter Facebook MySpace Digg StumbleUpon Delicious

Now is the time for the community to speak up. The more comments left on the dockets, the more support we give the FDA to make the changes needed for accurate diabetes testing. 

These dockets are only open until April 7
Don’t let another decade go by with inaccurate diabetes testing. 

Thanks and StripSafely,
Bennet & Christel

 

P.S. Want to learn more about the guidance? Check this out: 

http://www.stripsafely.com/sample-page/guidance/about-guidance/

 

 

So, please. Do it. Do. It. DO IT!

And thank you.

Monday Morning Musings…

1427584_81613555I took a little blogging break last week. It wasn’t intentional; I had other things cooking on the burners and gave them the time that was due to them. In the end, it all goes in the same pot, but it was strange to not write. (And that’s the extent of my chef metaphors.)

And now I sit with a large amount of caffeine, thinking about the good things that are happening in the diabetes world. In no particular order…

The Power of Community

According to an unofficial total (but from a source I trust), the Spare a Rose, Save a Child campaign raised…drumroll, please… $26,519. That’s a lot of insulin. That’s a lot of love. That’s a lot of lives that will be saved because the Diabetes Online Community raised their voices as one. I am in awe of the power of this community. For those who shared the message, thank you. For those who donated, thank you. (And it’s not too late to give a rose… )

StripSafely

Just because we’re not shaking the gates in person doesn’t mean that we aren’t working on ensuring blood glucose meter accuracy isn’t on our minds. Larry Ellingson has a guest blog post over at StripSafely.com, asking us all to join him in calling for congressional oversight of meter accuracy. I had the pleasure of meeting Larry at the DTS meeting in September, and I’m glad he believes as we do: whatever it takes to make sure we stay healthy and safe.

Think meter accuracy is not important? Larry gives another statistic that scares me (and it should scare you, too!):

 A second survey confirmed that 27 percent of patients with type 1 diabetes had experienced health problems due to inaccurate blood glucose meter readings.

The FDA can only do so much at this point. It’s up to us to rally together to bring Congress the news: we need their help. Bennet and I will be putting together some points that you can use when talking with your representatives soon.

It’s an i-port Advance

Medtronic announced the i-port Advance, an “all-in-one” injection port. For those who take multiple daily injections, it basically takes the place of injecting into different places… and into the injection port. You insert the i-port Advance and for the next 72 hours, you inject into the port.

Injection ports aren’t new. I remember using an injection port years ago. (I don’t remember why. It was probably a sample or two to see if I liked it, but obviously I didn’t care for it, because I didn’t use it for long.) If you have needle phobia, it’s a great way to ease the fear of having to inject more than once a day. If you micro dose fast acting insulin for optimum control, this may be a great way to avoid seven or eight injections each day.

There was a study done in 2008 about the impact of insulin injections on daily life and the results didn’t surprise me much. The study showed that out of 500 subjects, 29% of them stated that injecting insulin was the hardest part of their diabetes care. Fourteen percent of the subjects said that insulin injections have a negative impact on their life. So… obviously there’s a need to help alleviates some of the negativity. The i-port Advance is one way to do so.

The Future of Glucagon

For anyone carrying around that red hard case in the bottom of a bag or a purse or next to your bed, you will nod your head when I say this: Glucagon is a pain in the ass. (Sometimes literally.)

The Glucagon Emergency Kit has been around for quite a while, but unless you’re with someone who knows how to use it, it’s useless. If you pass out, the last thing a stranger will do is rifle through your bag looking for something to help you. Even if you’ve shown a friend or a work colleague how to use it, when push comes to shove (or push comes to drop on the floor), it may be too complicated.

True story: I would give a little primer about my glucagon emergency kit to my staff. New team member = pull it out and go through the motions. I would end every discussion about glucagon with this: “Call 911 first. Then attempt to inject me.” Then the discussion would be who would draw the short straw to do this. I trusted my team, but knew that glucagon was a last resort.

These days, I’m hopeful that glucagon will be available in an easier delivery mechanism – and perhaps even not by injection! Mike Hoskins over at DiabetesMine has a great article about Next-Gen Emergency Glucagon, in which he discusses the big issue: stability of glucagon. (Currently, once mixed, it’s good for 24 hours. After that, pfftt.) But even more exciting? This:

Assessment of Intranasal Glucagon in Children and Adolescents With Type 1 Diabetes – Yes. It’s a clinical trial that currently is recruiting kids for an intranasal dose… Could this be more awesome? Nope. I am hoping that this is what’s in store for all of us. I’d be much happier giving a primer about: Hold this up to my nose and squirt. Wouldn’t you?

By the way, there’s also a trial for adults: Effectiveness and Safety of Intranasal Glucagon for Treatment of Hypoglycemia in Adults. You can get a little more info here: Evaluate the Immunogenicity of a Novel Glucagon Formulation. The company behind this is AMG Medical, Inc. out of Canada. I’m eager to see the outcome of these trials!

So, as I sit here this morning, I’m buzzing with excitement (or is it caffeine) with hope for the future. What are you excited about?

 

Warning Label

mr-yuk-300x300It’s no secret how I feel about blood glucose meter accuracy: without it, I’m dead.

Blood sugar monitoring devices have become the linchpin in diabetes care. The number shown on a screen is what determines how much insulin I take, whether or not I eat 15 grams of carbohydrates, and in conjunction with a continuous glucose monitor, whether my blood sugar is going up or down. In the days before home blood glucose testing, it was a total shot in the dark as to whether you were “in range”, because urine testing wasn’t accurate. (Then again, neither was the insulins that were used.)

That’s why I’m a vocal advocate for the StripSafely campaign, bringing awareness of the need to tighten standards and help those who have sway over accuracy and accuracy enforcement of blood glucose testing systems. Since it began this summer, StripSafely has made an impact with the FDA and we are continuing to work with those who want to help ensure we get the accuracy we deserve.

A First For The FDA

When a device manufacturer wishes to bring a blood glucose monitoring system to market, it has to submit paperwork to the FDA showing that it’s met the requirements and standards for the device in question. If it already has a device approved, it’s an easier process with less paperwork, basically showing a comparison to the existing device and highlighting any differences.

A recent approval for a device manufacturer came with something never seen in the diabetes device market: a warning label on every test strip box insert, user manual, and meter box. (I’ve redacted the name of the meter because, you know, bears.)

CAUTION

Blood Glucose Meter Accuracy is the most important criteria in determining glucose meter quality. The {meter name redacted} is less accurate than most other blood glucose meters sold today. The {meter name redacted} does not provide reliable accuracy readings beyond the following margins of error:

For glucose concentrations < 75 mg/dL, 95% of the results shall be within ± 15 mg/dL.

For glucose concentrations > 75 mg/dL, 95% of the results shall be within ± 20%.

DO NOT USE THE {meter name redacted} TO CALCULATE INSULIN DOSAGES.
DO NOT USE THE {meter name redacted}TO CALIBRATE CONTINUOUS GLUCOSE MONITORS
And on every test strip box:
The {meter name redacted} is less accurate than most other blood glucose meters sold today.
DO NOT USE THE {meter name redacted} TO CALCULATE INSULIN DOSAGES.
DO NOT USE THE {meter name redacted}TO CALIBRATE CONTINUOUS GLUCOSE MONITORS
*Want to learn more? Visit this post at StripSafely: Thanks, FDA.

Why Would You Use A Less Accurate Meter?

Goodness gracious. So, for any person with diabetes who uses insulin (or may have to use insulin in the future, for those Type 2s currently on meds or on lifestyle modifications), you are cautioned by the FDA not to use this product. Why even bother purchasing it when you have other options? If you know that something is not accurate – and that accuracy does matter, why even bring it to market?

Money. Yeah. The meter and the strips are cheap, but what’s the real cost?

Health. Inaccurate blood glucose reading can result in wrong dosing decisions. It can result in hospitalizations. It can result in death.

I’m obviously not the target market for this meter, but I’m concerned that those who are looking to save on healthcare costs (or those who are under Medicaid or Medicare and are bound by whatever CMS approves), will not have a choice in whether or not they have to use it.

Mr. Yuk

The warning label is my most favorite holiday gift from the FDA so far. (Perhaps I’ll make a suggestion to the FDA that the warning label should have a Mr. Yucky face on it, which stood for poison when I was a kid.) I’m hoping that the manufacturer in question recognizes that this is an opportunity to either fix the accuracy of their product – or cut their losses and not bring it to the U.S. market.

Based on past history, however, the company may well just suck it up and stick the warning labels on their product, all for the sake of making a buck. And to that, I say this:

People with diabetes, we’ve got the FDA and StripSafely on our side.

 

Game on.

5 Thoughts About the DTS 9.9 Meeting

If you want the (mostly) objective summation of what happened at the Diabetes Technology Society’s meeting on September 9th in Bethesda, MD regarding blood glucose monitoring accuracy, you can go to the Strip Safely blog post that I wrote.

If you want to read my top five completely subjective thoughts on the DTS meeting, read on…

1. I want to move to Norway.Flag_of_Norway

They’ve already got the process/system in place over there that doesn’t allow inaccurate meters and strips onto the market. It’s basically what DTS has proposed to do here in the U.S. and it works brilliantly over there because the government believes in the program (called SKUP) and it’s mandatory. I don’t believe that the same thing will happen in the U.S. without it being mandated by Congress, which will take a while.

Dr. Grete Monsen of Norway gave an amazing presentation and gave a lot of advocates in the room a glimmer of hope.

(I’m kidding about moving to Norway. I love their sweaters, but I’m not big on the cold weather.)

2. They’re going to have to build a bigger boat.

Yes, a Jaws reference. Why? Because diabetes advocates have teeth.

A post-market testing program is going to need a lot of people involved and a lot of funding to go with it. The room was filled with representatives from industry, clinicians, government, and patient advocates. It wasn’t a ballroom, but there was a lot of dancing around issues that must be addressed. Most of it is regulatory and governmental and financial, but Dr. David Klonoff, the president of the Diabetes Technology Society said that they will be building a roster for a steering committee to start… and it must include patient advocates. When he first mentioned the steering committee, patient advocates were not included. Someone quickly reminded him of us and we were added during his final comments.

3. Dr. Gary Puckrein is my new hero.

Sitting at the end of the esteemed panel of clinical and patient representatives who all gave their views on the need for glucose monitoring accuracy, he waited patiently as others gave their views. I’m sure that he had his talking points and was ready to add his approval to the collective voice when Dr. Elizabeth Koller began reading her prepared statement….about how for her “patient population” (i.e. Medicare and CMS), accuracy really doesn’t matter and that the tools currently available are just fine.

(Look. I’m paraphrasing, because I began to see red and stream poured from my ears. With such dispassion, she essentially told all of us that we were wasting our time sitting here, because as long as the FDA approves a meter, it’s fair game for Medicare and they’ll choose what millions of people will use. Sort of a “nanny-nanny-boo-boo – suck it up and we don’t care because we’ll do what we want and what’s cheapest” attitude.)

Dr. Puckrein was called upon to speak and instead of launching into his prepared statement, he turned to her and (again, I’m paraphrasing) told her that what she was saying was scary and that if this is how Medicare and CMS was going to play…

“We are going to come after you like dogs.”

My hero. I want that man in our corner and thankfully, he is.

4. The FDA needs a good public relations firm.

I have to tip my hat to the FDA representatives at the meeting. They’re like Timex watches – they take a licking and keep on ticking. Diabetes advocates asked over and over about enforcement and what it would take to remove an inaccurate meter and strips from the market. They never wavered in their vagueness. We expect that. What we didn’t expect was the admission that they don’t do a very good job of explaining what they can and cannot talk about in terms of enforcement. I’d love to see a PR firm get their hands dirty and revamp the forward-facing portion of the “What we do” part of the FDA’s device division website, giving all of us a better idea of what steps they can and cannot take… so that we don’t have to repeated ask and get repeatedly shut down. It was frustrating to all of us – advocates and the FDA alike.

Boots5. We have a long road ahead. Get your boots on.

So, you may be asking… what’s next? Didn’t you get what you wanted? Aren’t we going to get better accuracy from our strips?

Answer…. Not without enforcement and making it mandatory. And funding.

It’s one thing to have a proposal. It’s another thing to make it happen.

Funding, whether through Congress or private philanthropic organizations, has to happen. This is not a “let’s get this on Kickstarter” project… this is a Dr. Evil putting his pinky up to his mouth amount of money… And it needs to continue to be funded.

Support from the government is essential and not just the “we think this is a great idea” lip service. Once the program is up and running, the data given to them has to be acted upon, especially if it is determined that some meters and strips aren’t meeting standards (Hint: some already aren’t…). Without enforcement and “if you show us the data, we’ll act on it”, this becomes another pie in the sky project. The only benefit is for those who can afford to pick and choose their meters and supplies without suffering financial setbacks because their insurance company won’t pay for the accurate ones. That’s unacceptable.

We have a long way to go…. and we will all be right there, because we want industry and government to see the faces of those that accuracy and diabetes impacts.

Every meeting. Every discussion. Every time. 

Disclosure: The Diabetes Hands Foundation compensated my travel and lodging to attend the Diabetes Technology Meeting on September 9, 2013. My thoughts and feedback are my own and are not representative of the DHF or the Diabetes Advocates program.