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. 

We're A Greedy Bunch, Aren't We?

We want. And want. And want.

Better accuracy. Cheaper supplies. Closed loop. Artificial pancreas. Easier diagnostic tools. Doctors who get the “whole picture” and not just numbers. More awareness of the differences between Type 1 and Type 2. More awareness of diabetes overall. A gag order imposed on the Diabetes Police. No complications. No deaths from diabetes. A cure. Heck, fast acting glucose flavor options that don’t make you gag would be nice.

We’re a greedy bunch, aren’t we?

We deserve all of these things. (Some things more than others…) We don’t just idly sit back and wait for them to come to us. We fight for understanding, for support, for encouragement, for community. Some brave souls fight long after their family members have lost their own lives.

I’ve always believed that nothing worth having ever comes easy, but sometimes I wish it wouldn’t be so hard. The financial aspect of diabetes alone is enough to drive one crazy. (And in my case, it’s a short drive.) According to the latest statistics updated yesterday (Did they know I was coming? They could have baked a cake!) from the American Diabetes Association, $245 billion dollars was spent on diabetes in 2012 between direct costs and lost productivity. 25.8 million people in the United States have diabetes (T1 and T2) from the 2011 stats… so, with my mediocre math skills, that comes down to…

Oh, forget that. I do enough math counting carbs and basal adjustments. It’s a lot. And I’m sure that’s not taking into consideration the cost of trying to eat healthier. (Hat tip to Kerri for the great post about food costs.) The cost of parents driving to and from schools to talk about the 504 plans for their children or to check a blood sugar or give an injection or change an insertion set. It’s not taking into consideration that we are bound to the ideal that we should take good care of ourselves now so we don’t burden our families years from now because we’re not eligible for long term care insurance. The costs of choosing between a needle that hurts a lot and a needle that hurts less. Ripping out an insertion set after two days hours because it’s occluded. The cost of choosing between accuracy and expensive and not so accurate but you’ll be able to buy other supplies.

We’re greedy. It’s not just dollars. It’s sense. (Yes, I know it’s actually cents. Work with me here, please.)

A sense of feeling good. Healthy. Not looking over our shoulders for the ever present creep of a low or the sledgehammer of a high. Not being second guessed by our medical team or the people we love or… by absolute strangers who think they know all about diabetes because they watched a Lifetime movie or Steel Magnolias or (insert grim face here) a relative.who.is.now.dead. Depression runs amok amongst us. Fact.  (If you want to get depressed, feel free to read this scholarly account.) I don’t know about you, but when I’m depressed, I am less likely to fight for what I need. I’ll take what I can get.

Cue the DOC. I definitely got what I wanted when it comes to that. A group of people who come from all walks of life, with different opinions and ideas, and varying levels of potty mouth to keep us all going forward. One person alone can make an impact, groups can make an impact, but oh… the DOC. Be still my heart.

For me, my DOC showed up in the mid 1990s with my discovery of a wonderful man…. David Mendosa. Know him? If you do, then you understand. If you don’t, then take a gander at “The List”. Put it this way, David was my gateway drug when I was jonesing for knowledge and feeling very alone. (Truth? I did not go to “diabetes camps”. I didn’t know a lot of diabetics. Like, I could count them on less than five fingers.) The Insulin Pump Forum helped me make one of the most important decisions of my life in 1999. I couldn’t have take a giant leap forward without their insights and support.

These days? Swing a cat. (A virtual cat, please. No kitties should be harmed in the name of this post.) Bam said the lady. Blogs. Groups. Conferences. Chats. A single phone call from the ER to one T1 friend connected me to a woman in Texas who had the same issues. Bam.

I found out that you want what I want. We want. And want. And want. Together.

Greedy? You bet. And we won’t stop until we get it.

(But until then… suggestions for fast glucose options that won’t break open in the bottom of a purse or glop everywhere and doesn’t taste mindnumbingly bad? I’m all ears. I’m certainly not all pancreas, but I am all ears.)