Two Minute Diabetes Advocacy: 21st Century Cure Act + CGM

708615_95129272One hundred years ago, those of us with Type 1 diabetes would be pushing up daisies. Pining for the fjords. Deader than doornails. Not living.

Today, thanks to amazing researchers and the advancement of technology, we are living longer, healthier lives. We are living in the 21st Century. No flying cars or Jetson butlers, but yet… we are making headway, at least on the healthcare front. But we need your help.

Here’s your two minute diabetes advocacy challenge for today.

(Less time than it takes to pop some microwave popcorn!)

The 21st Century Cures Act is a bipartisan (meaning both Democrats and Republicans are interested, which you know is rare!) attempt at vaulting U.S. healthcare into this century by changing the ways drugs, devices, and treatments are approved and marketed. It’s a whopper of a draft bill, currently, with five sections:

  • Title I—Putting Patients First By Incorporating Their Perspectives Into The Regulatory Process And Addressing Unmet Needs
  • Title II—Building The Foundation For 21st Century Medicine, Including Helping Young Scientists
  • Title III—Modernizing Clinical Trials
  • Title IV—Accelerating The Discovery, Development, And Delivery Cycle And Continuing 21st Century Innovation At NIH, FDA, CDC, And CMS
  • Title V—Modernizing Medical Product Regulation

If you want to read all 393 pages of the bill, have at it here.

There is a section for “Breakthrough Devices.” As The Regulatory Explainer (an amazing site!) explains:

As with breakthrough drugs, breakthrough devices are those which represent “breakthrough technologies,” are intended to treat conditions “for which no approved alternative exist,” offer “significant advantages over existing approved or cleared alternative,” are “otherwise in the best interest of patients”  and/or have the potential to “reduce or eliminate the need for hospitalization, improve patient quality of life.”

Continuous glucose monitors (CGM) fall soundly into that category and are currently covered under many private insurance plans (and some state plans), but once you age onto Medicare, if you have Type 1 diabetes and use a CGM, say good-bye to your coverage of that device. Out-of-pocket is your only option, and it’s cost-prohibitive. As people with Type 1 diabetes live longer, we are seeing that the tools that will help us most are not being offered by CMS/Medicare. This has to change.

We need to ask the Energy & Commerce subcommittee to include continuous glucose monitor (CGM) coverage for Medicare participants in the 21st Century Care Act.

Here’s where you can help in less than two minutes. (Throw that popcorn into the microwave right now.)

Got Twitter? Yes? Go!  

(No? Sign up for Twitter and help raise your voice to your representatives in Congress. They do listen! But it will take a little longer than microwave popcorn.)

Hit the start button on your microwave.

1. Click here. (http://www.stripsafely.com/the-twitter-page/) and read the quick info on that page.

2. Find out if your state representative is in the Energy & Commerce Subcommittee list on the page. (If you don’t know who your rep is, click here and enter your zip code. Voilà!)

3. Find your state and your rep and click on the “CGM in 21st Century Cures” and TWEET!

4. Share that page with everyone you know. (Look for the SHARE THIS link at the bottom of that page.)

5. You’re done. Carefully open that bag of microwave popcorn; contents may be hot!

Thank you for letting your representative in Congress know that including CGM coverage for Medicare participants is the right thing to do. No one should be denied coverage of this breakthrough diabetes device because of age!

Two Minute Diabetes Advocacy: MDDS

Tick-tock, y’all. 708615_95129272

This is a last minute push to get comments on the FDA docket currently out for medical devices. You have until 11:59pm ET Monday, August 25th to get this done.

Two minutes. That’s all it takes.

What is MDDS?

Medical Device Data Systems.

These are systems that, in the FDA’s words, facilitate

“the electronic transfer or exchange of medical device data from a medical device, without altering the function or parameters of any connected devices.”

 

Think about your Dexcom information on an iPhone or a tablet or a computer or a smart watch. Think about seeing boluses in real time. Think about being able to view medical data NOT on the device itself. For parents of kids with diabetes… kid is at school and mom or dad can see BGs in real time.

FDA thinks that this type of technology doesn’t introduce much additional risk, so they want to lessen the regulatory process (i.e. red tape) for these devices.

We totally agree. 

However, FDA isn’t clear on the topic of “active patient monitoring”, so our goal is to encourage the FDA to

  • Specifically address the importance of giving patients access to their own health data on multiple devices/screens (the more access the better), and…
  • Clarify whether CGM-related technologies will be included in the MDDS relaxed regulatory process. (We believe they should be.)

If you want to read up on this, you can get it from the source (FDA) and you can get additional information over at Strip Safely.

This is what you can do RIGHT NOW:

1. Copy the information below. 

I am encouraged by the FDA’s draft guidance on MDDS. I support the FDA’s position that technologies that transport data, without changing values, are low risk. I believe that access to medical data should be available on multiple platforms that are accessible to both medical professionals and patients. Access to this type of data is becoming increasingly essential in healthcare, with the potential to reduce costs and improve outcomes – in fact, not having timely access to needed data poses a far greater risk. I strongly support access to this type of data and am pleased to see FDA recognizing its importance.

People living with diabetes depend on data in order to minimize the chance of life-threatening complications that can arise with very little warning.

Suggestions:

The draft guidance seems to be focused on data provided by MDDS to healthcare professionals. It should be modified to also explicitly state the value of access by patients, particularly for chronic conditions like diabetes where patients need access to their own data to manage their own care as safely as possible.

Real Time:

The draft in section V-B seems to precludes active patient monitoring. Specifically how or if this impacts diabetes is unclear. A clear definition of active monitoring should be included in the guidance. I strongly suggest that real-time access by patients to their own data *not* be defined as active patient monitoring. I strongly support including in this guidance more open access to information from continuous blood glucose monitoring for patients with diabetes. The appropriate risk of device performance is regulated through the device PMA, and shifting CGM data to secondary screens does not in any way increase risk. From a patient perspective, secondary screens significantly decrease risk by making information more readily accessible to the patient. This is particularly relevant for those of us who may be unaware of early stages of hypoglycemia.

ER and Hospitalizations:

Geller et al estimate in JAMA (JAMA Intern Med. 2014;174(5):678-686. doi:10.1001/jamainternmed.2014.136.) that almost one hundred thousand Americans a year are treated in the Emergency Room for insulin related hypoglycemia and that about one third of those are admitted. Timely access to real time sensing data may help prevent many of these ER visits. This suggest real opportunity to mitigate risk through secondary device display of CGM information.

Multiple Data Sources:

Existing regulations state that ‘Accessories to classified devices take on the same classification as the “parent” device. An accessory such as software that accepts input from multiple devices usually takes on the classification of the “parent” device with the highest risk, i.e., class.’ (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm142651.htm ) People managing diabetes often use multiple devices to provide the data needed to follow care instructions. Bringing that data into a single application would improve patient understanding. For example finger stick measured blood sugar, CGM trends, amount of insulin infused, and the time of each are all information that patients juggle. A dashboard displaying all relevant diabetes data would improve safety and reduce risk, compared to forcing the patient to consult multiple devices and displays.

FDA’s Dr. Courtney Lias offered promising comments on diabetes and mobile devices at the Keystone 2014, “Practical Ways to Achieve Targets in Diabetes Care” sessions. Closer Look reports that Dr Lias, in comments on artificial pancreas, spoke of a strong FDA interest in consolidating devices through mobile technology to facilitate better diabetes care. She reportedly spoke of “component artificial pancreas system,” where patients could choose component devices of a system. I fully support the vision Dr Lias shared. This proposed MDDS guidance can encourage logical, safe and incremental steps towards that future by opening multiple diabetes devices to display on a mobile devices.

Conclusion:

Diabetes patients implement the individualized care programs created by our doctors based on real-time data from multiple FDA-approved medical devices. Easing the accessibility of data from those devices improves our ability to follow our care team’s instructions. I support the FDA’s adoption of MDDS guidance that incorporates a nuanced appreciation of the low risk and incredible value in using MDDS to transmit and display diabetes data.

2. Click here and paste the copied comment into the comment box. Wanna get fancy? You can add why this is important to you. There’s a 5,000 character limit, so you’ll need to delete some of the copied comment, but they’ll get your gist.

3. Then do this. 

  • Fill out your information. You’re commenting as an individual so UNCHECK the box that says:
  • “I am submitting on behalf of a third party”
  • Click the Category, “Individual Consumer”
  • Click continue.
  • Review, check the confirmation box
  • Submit your comments. You even get a receipt to confirm your comments were posted.

4. Do a little dance and high five yourself. You just raised your voice for diabetes advocacy. You rock. 

 

 

The KISS of Diabetes Advocacy

Find your excuse.

  • I don’t have enough time to commit to something that big.
  • I have no idea where to even begin.
  • I won’t make a difference.
  • I’m too shy to speak up.
  • I’m afraid I’d say something stupid.
  • Someone else will do it. 

Do any of these reasons not to advocate for diabetes hit home with you?

Once upon a time, I believed them all. (Well, except for the shy excuse. I’m a little bit of an extrovert. Just a tiny smidge.) Advocacy was this nebulous concept that was done by people who knew what they were doing and that was perfectly fine with me. Let the experts advocate for diabetes. Good for them! They would get something done and I would reap the benefits.

The truth is so very different. Those excuses listed above are balloons… and I am going to help you pop every one of them and show you The KISS of Diabetes Advocacy.

(No, this is not The KISS of Diabetes Advocacy.)

kiss-1800-1396461735

Let’s get The KISS out of the way first.

The KISS of Diabetes Advocacy is this:

Keep

It

Simple

Sweetheart (or Stupid, but you’re not, so it’s sweetheart, so there.)

Keep that in mind while we pop the balloon excuses…

I don’t have time to commit to something that big.

You can be a diabetes advocate in less than a few minutes a day. We showed you that it can be done in about two minutes (or even less.) At the MasterLab held at CWD’s Friends for Life, a three step plan was laid out for you on one webpage. Click, click, click and you’re set with the Diabetes Action Hub. Three quick things to start.

(Take a survey, send a quick email to your representative about two bills that will help all people with diabetes, and sign up to get notified about advocacy actions that you can take in the future.)

You do what you can. No one is asking you to chuck your job and go on the road, stumping daily for diabetes awareness or reimbursement. No one is asking you to spend your days in a monkey suit, waiting in corridors to spend a few minutes with an aide for your Congressperson. Pick what is important to you, but don’t do nothing. You can make a difference in a few minutes per day.

I have no idea where to begin.

The American Diabetes Association does an outstanding job with explaining how easy it is to advocate for diabetes. It’s a great primer if you have no idea where to begin. It’s a great starting place. If you don’t even know why you should advocate. you can look at the list of federal priorities that the ADA has set out to accomplish this year (all very ambitious, and all need help from people like us).

I won’t make a difference.

Think so? You do. Every letter that is written, every call that is made, every tweet, every visit raises awareness of what diabetes is, how it impacts us, and what we need to be healthy. We saw the difference over 300 of us made when we voiced our comments on the accuracy of blood glucose meters to the FDA. Can you imagine what 3,000 comments could do? 30,000?

In the 80s, I threw my insulin, syringes, meter, and strips in my backpack and tra-la-laed my way down the halls of my school. Needed to check? I pulled out my meter. Needed to take an injection? Pulled out a syringe and did it myself.  To do that today would have the administration of any school screaming, some more loudly than others. Imagine not being able to have anyone besides a nurse administer insulin or glucagon to your child or someone you love in a school. It was happening in California. Advocacy changed that. It took eight years, but now trained personnel can help in schools without a nurse present.

Every time you share the difference between Type 1 and Type 2 diabetes, or explain what insulin does, or why you can eat that donut, you are advocating for diabetes awareness. Want to rattle off some statistics? Easy. Here is the full list, but you can memorize this one from the CDC:

If current trends continue, 1 of 3 U.S. adults will have diabetes by 2050.

If that doesn’t freak you out, I’ve got others. Let me know and I’ll send them to you.

Talk about diabetes. The one smart thing I said at MasterLab was this: “Advocacy begins with you.” And by you, I mean you.

I’m too shy to speak up.

Then don’t speak. Write your congressman. Write an article in your community newspaper. Tweet important information and disseminate advocacy actions to others. Do art that can be used in presentations at hearings and meetings that make an impact.

Diabetes Art Day images surrounded Manny Hernandez and me at the Diabetes Technology Society meeting last September. It made an impact.
Diabetes Art Day images surrounded Manny Hernandez and me at the Diabetes Technology Society meeting last September. It made an impact.

People who advocate “behind the scenes” do important things. Put a walk team together. Help raise funds for research or technology that will help improve the lives of people with diabetes. You don’t have to shout with a megaphone to get your voice heard.

I’m afraid I’ll say something stupid.

Know what’s stupid?

Not saying anything and accepting the status quo. 

Was that blunt? As blunt as my lancet is right now because I haven’t changed it in a while.

If you get the facts, understand the players, and find out what your passion is, you won’t be stupid and nothing out of your mouth will be stupid.

What bothers you most about diabetes? Good. That’s your passion.

Then google information about your passion and get information about the facts surrounding it and the key players. (And by players, I mean your fellow advocates or advocacy groups and the people you will need to influence to change the status quo.)

Once you’ve got that, work with your fellow advocates to change the status quo.

Someone else will do it.

That was my biggest balloon excuse. It was so big that it carried me up into the stratosphere for years and years. And then something happened.

I got angry.

And then…

I got angrier.

And then…

I recognized that even people who should know the difference didn’t.

There was no moment in which I decided to advocate. When I realized that I needed to speak up for myself and then for those who couldn’t speak for themselves, it was a no brainer. There is so much to do in the world of diabetes advocacy, so much status quo that needs to be shaken, that I now wish I could do it all.

Which brings me back to The KISS of Diabetes Advocacy. (You thought I had forgotten, right?)

Keep It Simple, Sweetheart.

Start small. Sign up for advocacy alerts. Pick something that that you want to see change. Send an email or a tweet. Ally yourself with others who share that want for change.

If that all feels good, then flex your wings and step outside your comfort zone. I quaked in my heels as I stood in front of a panel of people in Bethesda last year, asking the FDA representative what it would take for them to pull an inaccurate meter or strips off the market. My heart pounded in my throat (where it shouldn’t ever be) and I was sweating, but I wanted to let them know I wasn’t accepting the status quo.

We can all be advocates. Come join us. We need your help.

Procrastinators Unite… Tomorrow!

1267744_87396573You still have time, you procrastinator you.

The docket that FDA has open on blood glucose test strips has been extended to May 7th. You can use the “Ain’t Got No Time For That” method that I came up with for all of us to comment and kick the number over the 400 comment goalpost. (Or more than 400? Be still, my beating heart.)

Even if you have commented, no one is telling us that you can’t comment more than once, so please bring your thoughts about generic/third party test strips.

Third party test strips are not made by the monitor manufacturer, so who’s responsible if there’s a need for adverse event reporting? Who do we call to report it?  Until there’s a clear cut ruling on this, it’s a Wild West sort of world.

Want to learn more about third party test strips and inspiration for your comment? Head on over to Stripsafely.com and read up. (There’s also a great article on this very topic and details about the companies offering generic strips at Diabetes Mine. A definite must read.)

I know that you’re not a procrastinator, but I’m sure that you know someone who might be. Can you do the 26 million people with diabetes a favor today and reach out to someone in your community (with diabetes or not) and ask them to do you a solid?

Diabetes doesn’t procrastinate. We shouldn’t either…

 

Where All The Cool Kids Will Be On Monday…

Less than a year ago, Bennet Dunlap decided that the status quo just wasn’t good enough for us.

We needed to band together as a community to talk about blood glucose meter accuracy and what it means to the 26 million people with diabetes (and growing). Better accuracy begets better control and better outcomes for those of us who rely on our blood glucose meters to give an accurate number. Better accuracy, quite frankly, wasn’t happening.

So, Bennet created the Strip Safely campaign and gave us all a voice under the Strip Safely umbrella. I’m the Robin to his Batman, mostly saying: “Holy glucose meters!” and ensuring our costumes are freshly pressed by Alfred. It’s an honor to work with him and every other person who believes in the importance of blood glucose meter accuracy.

Last summer, Strip Safely attracted the notice of those at the FDA and a relationship began to develop, one that has grown into something important for the diabetes community… and on Monday, you can see for yourself.

This is where all the cool kids will be on Monday… on a Live Chat with Bennet and Dr. Courtney Lias.

(P.S. You are a cool kid, if you were wondering.)

Here’s the details:

FDA

Talk with FDA expert Courtney Lias and Patient Advocate Bennet Dunlap about Glucose Monitors and Test Strips

Monday, March 31, 1:30–2:30 pm (EDT)

  • Do you want to learn more about the role of the FDA in the regulation of medical devices, such as glucose monitors and test strips, used in the management of diabetes?
  • Do you want to learn what the FDA is doing to increase the accuracy of blood glucose monitors and test strips?

When you participate in this friendly online chat, you will:

  • Enjoy an informal, open discussion with a fellow patient advocate, Center for Devices and Radiological Health subject-matter-expert and others in the diabetes community.
  • Learn more about the role of the CDRH, specifically the Office of In Vitro Diagnostics and its work to ensure the safety and effectiveness of medical devices used in the management of diabetes.
  • Get your questions answered about the newest FDA draft guidances, which are proposing new recommendations intended to improve the accuracy and safe use of blood glucose monitoring test systems, giving healthcare providers and people with diabetes better tools to manage blood glucose levels.
  • Whether you want to just listen to the interview, ask relevant questions about the medical device regulatory process or just speak your mind on the newest draft guidance document…. you should join in the conversation.

Register for this event and be sure to mark your calendars and join us on March 31st, 2014.

Please let your friends in the diabetes community know about this event. While not all the cool kids will be able to make it, I hope that you’ll join us all on the chat and learn how you can help the community and FDA. We are a community and we can’t do diabetes alone.