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Posts tagged ‘FDA’

Help People with Diabetes Access Care Data; Medicare CGM Coverage.

There are advocacy tides rising this morning, and we have a chance to jump on board.  There are two opportunities to raise our voices.

The FDA has proposed new guidance for  Medical Device Data Systems (MDDS) and the diabetes community has the opportunity to comment on that guidance document.  There are more details on the StripSafely website as to what that means and why we should care.  We have until August 25th to leave our feedback.

Here’s what you can do:

Leave Your Comment on the FDA Draft Guidance.

1.  Highlight and copy the text in red below:

Support:
I am encouraged by the FDA’s draft guidance on MDDS.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.

Diabetes:
People living with diabetes depend on data in order to minimize the chance of life-threatening complications that can arise with very little warning. I am happy to see that in his blog post Bakul Patel specifically mentions diabetes devices. I support this guidance’s decision to not mandate the PMA process for MDDS that include diabetes information.

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The draft guidance seems to be focused on data provided by MDDS to healthcare professionals.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 text you copied into the comment box.
3.  Fill out your information.  (Note:  You’re commenting as an individual so be sure to uncheck the box that says: “I am submitting on behalf of a third party.”)
4.  Click the Category “Individual Consumer.”
5.  Click continue.
6.  Review, check the confirmation box, and submit your comments.

Sign the “Tell Medicare to Cover Continuous Glucose Monitors for People with Diabetes” petition from the JDRF. 

People with diabetes live longer, healthier lives these days.  (Celebrate!)  As a result, so many of us have the privilege of aging well.  Bottom line?  We’re getting older.  And when we enter the Medicare age bracket, continuous glucose monitors will not be covered by our insurance.  But we have a chance to change things.  Here’s something you can do in less than 1 minute that will make a difference:

  1. Click here for the petition.
  2. Sign it.
  3. Share it.
  4. Pat yourself on the back and carry on.

Oh, this is a real thing with an actual patent pending. (source)

Thank you for giving these issues your attention.  The community is lucky to have you.  And you.  But especially you.

 

Friday Six: But Not On Friday.

SUM stuff from around the Internet:

“The latest in this trend is the meme showing a fat little girl titled ‘Lil Diabeetus snacks’ as a take-off to Little Debbie Snacks.  It’s being bandied about on FaceBook as ‘cute’ and ‘funny’; an appropriate name change.  Is it funny?  I don’t think so.”  Kate weighs in on the Facebook meme.

Tuesday’s #dblogcheck was a community success, and seems to have woken up many of the sleeping bears (if you want to picture blog commenters as sleeping bears, which I do, because that’s adorable).  Check out Chris Snider’s excellet Storify recap of many of the blog posts and be sure to say hello on some new and old blog favorites.

Wendy’s daughter has gone to Clara Barton Camp … and she’s also gone BIONIC.

Athletes inspire kids with diabetes at Friends for Life Conference” is the title of this video, but I’m going to assert that adults are pretty inspired by Charlie and Jay, too.

An eighth grader took She Still Smiles and made it into something really, really cool.  Read about Talia’s project here.

“Her former team dismissed her for having diabetes. Her coach and teammates stood by her and struck out on their own.”  Read more about Rebecca Young here, and consider supporting her!

I sent emails to my representatives.  Now it’s your turn.

The “Fakeabetes” Challenge – pretending to be a PWD for the day!  Read more from Kim and Whitney on this day with diabetes.

This post from Meri is a call-to-arms, and I’m ready.  “The Movement Has Begun.”

JDRF appoints Derek Rapp as new President & CEO – here’s more information on this change in leadership from the mothership itself, and a post about the changing leadership of ADA and JDRF on Diabetes Mine.

Why Should Diabetes Advocates Enter This Food Fight?”  Hope Warshaw explains.

“ADA and others have sent in their comments, but the FDA needs to hear our individual voices as advocates.”  You can give the FDA your thoughts on the proposed Nutrition Fact Label, and you have until August 1st to do so.  More on the how, and why, at Diabetes Advocates.

The FDA will host an online conversation (“A Virtual Town Hall”) for people with diabetes on November 3.  And, according to the crew at diaTribe, they want to hear from you!  Click this link for more information and the link to email diaTribe, and you can also join the conversation on Twitter using the #DOCasksFDA hashtag.

My favorite part of this video?  “I can read.”  Love, love, love.

5,000 Names Needed.

There’s a petition circulating to add diabetes as a disease topic to be discussed over the next five years.  Diabetes, despite the number of people touched by it, isn’t on the list.

Yet. 

If we can gain 5,000 signatures on this petition, we have a better chance of adding diabetes to the discussion docket, helping improve the lives of those we love.  It takes about fifteen seconds to sign the petition.  Do you have fifteen seconds to spare to help raise the voice of the diabetes community?

Yeah you do.

“The Food and Drug Administration has begun to hold a series of patient meetings to gain a better understanding of specific diseases. Over the next five years, the agency plans to conduct at least 20 such meetings on conditions ranging from Chronic Fatigue Syndrome to Narcolepsy to Irritable Bowel Syndrome.

But not diabetes.

That is unacceptable.

Four “slots” remain open (view the current list), and we want the FDA to add diabetes to its meeting docket for 2013.

According to the American Diabetes Association, nearly 26 million Americans have either type 1 or type 2 diabetes,and an additional 79 million have prediabetes. Those numbers are also increasing each year – the CDC estimates that if current trends continue, one in three US adults will have diabetes by 2050.

No one disputes that diabetes is one of America’s – and the world’s – most serious health epidemics. In 2012, more than one in five total US healthcare dollars was spent on diabetes, totaling $245 billion, and the government covered 62% of those costs, meaning everyone is paying for this epidemic. Despite growing needs, research dollars have also leveled off.

New therapies need to be investigated, tested, and brought to market, and as part of that process, the FDA must understand the daily challenges that patients face.

We need to tell our story to the FDA: about the need for accurate strips, more physiologic insulin, a broader range of drugs, and the Artificial Pancreas.

Our voices need to be heard.

Please sign this petition to urge the FDA to sponsor a patient meeting focused on diabetes – and the sooner, the better.

Thank you very much.”

Roulette.

I test my blood sugars between 8 – 15 times per day, depending on trends, travel, exercise, food, and other variables.  I correct highs.  I treat lows.  I make a lot of decisions based on these numbers, and it scares the hell out of me to think that they might not be right.

Food for thought.

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