Two Minute Diabetes Advocacy: CGM Medicare is Back and FDA Goodness

708615_95129272It takes two minutes to make a difference for people with diabetes. Here’s the latest on how you can help.

CGM Medicare Bill: It’s Back!

Want the back story? It’s here.

Right now, Medicare does not cover CGM devices, leaving seniors with diabetes without access to this technology. Among the most important goals of our advocacy and education efforts is to ensure that those entering the Medicare program at age 65 do not experience disruption in their diabetes management. (None of us with diabetes is getting younger. If you are, please let me know your secret!) I don’t want a single person to be denied coverage of this device simply because of their age (or any other reason for that matter, but first things first, right?) and we have an opportunity to make a difference for our entire community.

Remember that this bill will also help when artificial pancreas technology comes to fruition. We need everyone to get involved.

The Medicare CGM Access Act has to be reintroduced in both the House and Senate in order to move forward. (New Congress = sort of starting from scratch, but this is a good thing, in my opinion…)

Representatives Tom Reed (R-NY) and Diana DeGette (D-CO) just re-introduced the bill in the House. Senators Susan Collins (R-ME) and Jeanne Shaheen (D-NH) are expected to drop the parallel legislation in the Senate very soon.

57 members of Congress co-signed the bill last year. This is a great start, but we need your support and the support of your communities to drive more co-signatures.

Here’s what you can do RIGHT NOW:

Contact your representative (for the first time – or again!) about supporting and co-sponsoring this bill. 

Yes, you may have done this last year, but you may also have a new representative in your district or your representative may not have heard you the first time. Every. Voice. Matters.

FDA Goodness:

Clinical Considerations of Risk in the Postmarket Environment

If you care about the medical devices that we use each day to manage our diabetes (think insulin pumps, CGMs, blood glucose meters) and the risks that we take (and how to mitigate those risks), then sign up to be a part of this workshop. This will be webcast, so you can participate from the comfort of your home or office, but sign up ASAP. Registration will close on April 13th. Those in the DC area should know that you can attend this in person on the FDA Campus. Here are the details:

The FDA has announced a public workshop entitled “Clinical Considerations of Risk in the Postmarket Environment.”  The purpose of the workshop is to provide a forum for an interactive discussion on assessing changes in medical device risk as quality and safety situations arise in the postmarket setting when a patient, operator, or member of the public actually uses the device.  For details and registration, please see: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm436365.htm

Date, Time and Location:

This meeting will be held April 21, 2015, beginning at 8:30 a.m. at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993

Get some knowledge and take the world by storm. We can do this together!

#DOCAsksFDA Needs You

FDACalling all PWDs! Calling all PWDs! Pick up the bat phone!

 

O.K., really, just need you to take a quick survey to help the entire diabetes community. 

On November 3, the FDA will host an unprecedented discussion between the diabetes community and senior agency leadership (both drugs and devices). 

The event will be live webcast from 1 – 4 pm.

How much of a big deal is this?

Big. Super mega colossal big. 

The event will include a panel of patients (T1 and T2), as well as representatives from ADA, JDRF, and diaTribe.

Each of us live with challenges due to our diabetes every day. Take a few moments to share your thoughts on what’s important when it comes to living with diabetes.

The survey, posted over at Diatribe, is short. The results will go DIRECTLY to the peeps over at FDA and will influence the dialog that will happen on November 3rd. Diatribe is asking those with diabetes (Type 1, Type 2, MODY, LADA, etc.) to help gather all of our thoughts.

We need to show the FDA that patients care about these issues, that patients have valuable input to share, and that the treatment options we have are still not good enough. 

As soon as the link to register for the live event is posted, I’ll get you the details. In the meantime, the survey awaits your input.

Help the FDA understand what we want for our future.

They’re listening.

Let’s tell them.

In No Particular Order – Diabetes Neat-o News

1199767_63019393Sometimes, I’ll see something diabetes related that interests me and I file it away in my inbox, saying: “I’ll share that…”

Today, I’m cleaning out my inbox. You’re welcome.

In no particular order:

But here’s the interesting tidbit:

“…the clinical data demonstrated that the two meter systems exceeded the minimum accuracy criteria for the new, more stringent ISO 15197:2013 performance requirements for accuracy.”

You know how I feel about blood glucose meter accuracy. We need it. Better accuracy from our blood glucose meters, better accuracy for our CGM readings, better dosing and food choice decisions = better days.

This is from a company that offers relatively inexpensive meter and strips. The devices will be on shelves by Q4 of 2014.

  • Close Concerns/diaTribe has it going on all over the place. I strongly encourage   demand that you take a moment to check the following out:

Kelly Close, the woman I swear never sleeps because she’s so busy doing amazing things for the diabetes community, presented this at a recent FDA meeting a few weeks back. (Click on this link to get her insightful slide presentation… so worth going through… it totally surprised me, and I’m pretty jaded these days.)

And then, there’s the work that DiaTribe is doing for #dstigma (diabetes stigma). Those of us who live with diabetes have probably felt unreasonably stigmatized at some point, whether it’s with friends, colleagues, strangers… and they’re showing this to the public in hard numbers. They did a study, and here are the results… and I love the fact that they’re not just satisfied with dumping the results on our lap. We’ve got work to do, people.

I got to see this in action at the AADE conference in Orlando and was blown away. While I use a pump that does the calculations for me, if I didn’t, this would be the meter I use. Imagine not having to do the math when you want to inject:

“If my blood sugar is 196 and my target is 100 and I’m going to have 48 grams of carbohydrates but I took a correction bolus an hour ago so I’ve got insulin on board….how much insulin should I take?”

It’s easier to ask what time the train will arrive. The answer may be just as elusive. But this meter will do it (but don’t ask what time the train will arrive).

It’s not available off the shelf – you will need to ask your medical team to get you one, but if you’re on MDI… whoa. Get one of those in your hot little hands.

  • National Medical Device Curriculum – Stop whining about how complicated the FDA makes the process of getting a device approved and start figuring out why. (Look, I used to whine. Not anymore.)

What is it? It’s a learning pathway for anyone who wants to know what it takes to get a medical device approved by the FDA, starting from scratch.

The National Medical Device Curriculum is a series of fictional case studies designed to help academic institutions and science and technology innovators understand FDA’s medical device regulatory processes. The FDA believes that better understanding of regulatory processes will accelerate the delivery of innovative medical devices to patients.

Regulatory pathways, PMA, 510(k), acceptable risk… it’s all covered with case studies. So worth your time if you are using ANY medical device to manage your diabetes.

Take a gander. Bookmark it. Share it. Discuss it. The more educated we get as a community about what the FDA does, the more we can help the FDA and device manufacturers with the process.

Thank you for helping to clear out my inbox. I feel so much better now. Do you do windows, too? 

 

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. 

 

 

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.