Fab Five Fridays: "Happy" Edition

IMG_3985I’d like to thank Pharrell Williams for that infectious little ditty stuck in my daughter’s head.

“Happy.”

Whenever she hears that song, the dancing must commence.

No matter what you might be doing, just drop it.

Grab a hand, jump up and down, and wiggle wiggle wiggle.

These are the instructions The Kid gives to me, drill-instructor style, while grinning and giggling.

She makes me happy. Just like these five things you should know about:

1. The Diabetes Technology Society announced the DTS Surveillance Program for Cleared Blood Glucose Monitors.

How important is this?

Wicked.

Epic.

For those of us who wonder if the number on our blood glucose meter is accurate, it’s a majorly huge thing. Once a blood glucose meter is released to the consumer after approval by the FDA, there is no way to find out if these meters are… accurate. This is the post-market surveillance program that Strip Safely and advocates of meter and strip accuracy have been wanting (and the FDA, too!) – it’s coming!

“This surveillance program will provide a significant benefit to both patients and manufacturers,” says David Klonoff, M.D., founder of Diabetes Technology Society and Clinical Professor of Medicine at University of California, San Francisco.  “Patients will benefit by having access to more accurate meters on the market and manufacturers committed to delivering accurate products will now have an opportunity to back up claims about quality and accuracy with proof from this independent, third-party testing program.”

Abbott Diabetes Care is already committed to supporting this program and other major manufacturers will be signing on, of that I’m sure. Manufacturers who do not pass the accuracy guidelines at this point will still be allowed to sell in the U.S. market, but I foresee these accuracy reports becoming important in the future as the FDA looks closely at how to ensure our safety with the help of the DTS. Huzzah!

2. The 2014 Diabetes Mine Patient Voices Contest is waiting for YOU

From the DiabetesMine website:

The 10 top entrants were selected to receive an “e-Patient Scholarship” to attend the DiabetesMine Innovation Summit that takes place annually at Stanford University in Palo Alto, CA. Each year, our winners act as “delegates” for the patient community, expressing our needs and desires to the Powers That Be: decision-makers in pharma, healthcare, technology design, medical device regulation, software and app development, national advocacy groups and more.

This year, the DiabetesMine Innovation Summit will be held on November 10, 2014. Your entry is a product review video for the DiabetesMine Test Kitchen – and it needs to be in by June 19, 2014.

As a 2013 Patient Voices scholarship recipient, I say this:

The DiabetesMine Innovation Summit was a watershed experience for me. The passion of those attending from various communities: medical device, pharma, clinicians, developers, investors, insurance, and patient advocates was electric and infectious. All of us arrived wanting to share how we could work together to make life with diabetes easier using technology. We left with new ideas and a better understanding of what we need to do to make that happen.

If you have the opportunity to attend, do not pass it up.  And this is your opportunity to attend this invitation only event!

3. Sweet! Advantame – the newest artificial sweetener to be approved by FDA on May 19, 2014. 

For those of us who are stuck with limited choices for artificial sweeteners, here comes Advantame. It’s super concentrated sweet, but here’s the scoop from the FDA’s site:

Advantame is chemically related to aspartame, and certain individuals should avoid or restrict the use of aspartame. To that end, FDA evaluated whether the same individuals should avoid or restrict advantame, as well.

People who have phenylketonuria (PKU), a rare genetic disorder, have a difficult time metabolizing phenylalanine, a component of both aspartame and advantame. Newborns are tested for PKU using a common “heel-prick” test before they leave the hospital.

Foods containing aspartame must bear an information statement for people with PKU alerting them about the presence of phenylalanine. But advantame is much sweeter than aspartame, so only a very small amount needs to be used to reach the same level of sweetness. As a result, foods containing advantame do not need to bear that statement.

So, heads up – it’s chemically related to aspartame (Nutrasweet). I’m a sucralose (Splenda) chick when I use artificial sweetener (I buy Diet Coke with Splenda in can form, and have been known to bring my own 12 packs everywhere…). I try to avoid aspartame, so this new sweetener will be interesting to watch from a marketing perspective.

4. Speaking of Sweet!, I’m over at A Sweet Life, too. 

I recently wrote an article about guilt and food and diabetes. See them all traipsing off into the sunset together? That’s what I’m talking about. (Spoiler: They don’t traipse off well.)

There are some stupendous articles written by some of my favorite peeps… and I’m happy to have been asked to add my voice over there. Pop on over and check the site out!

 

5. Diabetes Hands Foundation has got you in mind: MasterLab for Diabetes Advocates on July 2nd in Orlando

Want to be a champion for effective diabetes policy? You’re in luck. The Diabetes Foundation will host the very first MasterLab, July 2, 2014 at Marriott’s Orlando World Center in Orlando, Florida! We are excited to offer the first of its kind, action to amplify diabetes advocacy. If you don’t have a background in diabetes advocacy, that’s ok! No previous experience needed.

I never thought I would be an advocate for diabetes. Hell, I never thought I’d be an advocate for anything. It’s funny how life brings you to new places.

I’ve learned a lot since I made the decision to speak up for myself, but I still have a long way to go… and I’m thrilled that this is happening.

Please seriously consider joining us.. Learn more and register here…

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And a bonus Fab Friday Happy, because I’m deliriously happy about this…

Register for The Diabetes UnConference. We don’t want to miss you while we’re there, talking about the things that are important to us – people with diabetes.

Come on, it’s Vegas. un-diabetes-conference-fullcolor-icon

 

 

 

Now go wiggle, wiggle, wiggle. Make yourself have a happy day.

 

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.