Tag Archives: advocacy

Show the love, save a life.

January 30, 2015 – 1:12 pm

SAR2015
 
 
I’m headed out of the country for the next ten days, so depending on how my work and play schedule goes, you may or may not read more in this space over the next week and a half.

But before I depart, I want to remind you that it is always the season of…

Paying it forward.

Hope.

Life.

The Spare A Rose, Save A Child campaign begins February 1.

If you’re reading this, you’re probably one of the lucky people who have access to the life-giving insulin that keeps our blood glucose from skyrocketing, causing sickness and complications, and even death to People With Diabetes. You may pay a lot for it, but you have access to it. In fact, you may have a ready supply in your refrigerator at home right now. This morning, I counted 8 vials of this life-sustaining medicine in my fridge.

But you know, there are a lot of kids who do not have access to insulin, let alone a refrigerator, and for them, a diabetes diagnosis could be a death sentence. That’s where you and I come in.

Partnering for Diabetes Change and the International Diabetes Federation have teamed up once again to help raise money for the IDF’s Life for a Child program through Spare A Rose, Save A Child.

Really, what they’re doing is helping to save the lives of Children With Diabetes in 49 countries around the world who would be facing an extremely bleak future if you or I didn’t act, now. The idea is simple:

Have a special one in your life? Would you send roses to that person this Valentine’s Day? Going on the premise that one rose would cost about five dollars (US)… If, instead, you donated that five dollars, that cost of one rose, to the IDF’s Life for a Child program, you could help them purchase insulin for a child in a developing country for an entire month.

It’s that easy to see how your donation can make a difference. Five dollars saves the life of one child, for one month. But why stop there? By that math, the cost of one dozen roses could help a child live for an entire year! Last year, donations totaled enough to provide a year’s worth of insulin for 454 children while raising over $27,000. Can we do even better this year? With your help and my help, I think we can.

Click here or on the banner at the top of the page to be a lifesaver today.

This year, there’s even a way you can set up an automatic monthly donation via your bank card. Imagine looking at your bank statement each month and saying to yourself “Power bill, auto loan, Oh, look at that… there’s where I saved the life of a child (or two, or five, or ten) this month”. How freakin’ powerful is that?

And hey, can you do one more thing? Can you let the world know about it? I mean, why should you and I be the only ones out there saving lives? Let’s help others get in on the action too. Be sure to share the Spare A Rose campaign everywhere you have a social media footprint, and at work and school too. Share the giving link and the #SpareARose hashtag liberally. For more ideas on how you can help spread the message, go to SpareARose.org.

Five bucks, one child, one month of life. That’s a very measurable way to put a value to how you can make the difference– a life-sustaining difference– right now, today.
 
 
 

By StephenS | Posted in Advocacy | Also tagged , | Comments (4)

Got two minutes?

December 10, 2014 – 1:51 pm

Hi… I just have a couple of minutes during a very busy day, but I need to ask your help once again.

The U.S. Food and Drug Administration is asking us for our take on insulin bolus calculators. This goes back to the public workshop that I attended back in November.

Specifically, they’re looking to us for feedback on bolus calculators. As we know, they’re helpful for people to perform (or double-check) their insulin boluses prior to delivery. During the workshop’s panel discussion, Adam Brown of diaTribe did a fantastic job describing how someone using a bolus calculator, even an imperfect one, was better off than someone using no calculator at all.

Fortunately, Bennet Dunlap has prepared a super-helpful post over at Strip Safely that will help you get everything you need to comment simply and effectively on this docket. Go there, and you can perform your Wednesday dose of diabetes advocacy in a couple of minutes.

The FDA would like you to consider these questions with regard to bolus calculators:

1. How can patients and providers be confident that the insulin bolus values obtained from the calculators are accurate and appropriate for their use?

2. What information do patients and providers need about how a particular calculator works so that they may appropriately use the calculator for diabetes management?

3. How can FDA foster both innovation and safety of insulin dose calculators intended for use by healthcare practitioners?

4. How can FDA foster both innovation and safety of insulin dose calculators intended for use by patients?

Okay… I don’t have a lot of time, so I encourage you to visit Strip Safely and view Bennet’s post. The docket is only open for a little while longer, so time is of the essence.

Don’t forget to tell your story! It’s important to convey your role as a patient or a caregiver of a patient, since no one understands our diabetes the way we do. To get links and additional talking points, go to Bennet’s post. For the record,

Here is the link to the request for comments

Here is the link to comment
 
 
Thanks again for your help, your continued help, in getting the important facts and the right message to the FDA. Happy Wednesday!
 
 
 

By StephenS | Posted in Advocacy | Also tagged , | Comments (0)

It’s Black Friday. And I need your help.

November 28, 2014 – 8:50 am

Did I say I need your help? In fact, we need your help.

For the next week, the U.S. Food and Drug Administration has a docket open, waiting for public comment from you and me and anyone else living with or affected by diabetes. What makes this docket unique is that they are actually asking us to weigh in on how we want to be included in the review of diabetes devices and drugs. Can you believe it?

From the FDA’s official docket:

The Food and Drug Administration (FDA) is announcing the establishment of a public docket for comments on FDA activities performed under the Food and Drug Administration Safety and Innovation Act (FDASIA), Patient Participation in Medical Product Discussions. This notice announces FDA’s intent to gather input from stakeholders on strategies to obtain the views of patients during the medical product development process and ways to consider patients’ perspectives during regulatory discussions.

The thing is, we only have until next Thursday, December 4th, to respond. After that, our opportunity is gone. Can you help? Will you please be an advocate and comment? It’s very easy to do, and so, so helpful.

Here’s the link to the public docket

Here’s the link to leave a comment on this docket

Needless to say, it’s absolutely necessary to let the FDA know how important the patient perspective is in the review of things we use to manage our diabetes and stay alive every day. How can you do that?

Tell your story! Personal stories are more important than statistics. Just speak from the heart and tell them what’s important to you, and why. In addition to your personal story, you might want to include these ideas too (feel free to cut and paste):
 
 

– Thank you. Thanks for the FDA’s openness with the Diabetes Community in 2014. FDA opened a number of dockets for people with diabetes to comment. The docket on glucose meters and MDDS provided specific opportunities for diabetes patients to share our views on accurate glucose measurement, and how great it would be to share that information with our support systems.

– FDA engaged in two significant and well received webinars that the community referred to as #DOCasksFDA. These were unprecedented opportunities for patients to hear from FDA and use social media to talk among themselves about specific issues. These webinars were a significant opening and I feel there is an ongoing need to continue the dialog.

– FDA came out and participated at a number of events including the DiabetesMine Innovation Summit, MasterLab at Friends For Life, Keystone, ADA Scientific Sessions, AACE, DTS, and other events. These help consumers as well as physicians and researchers better interact with the agency.

– 2014 saw the creation of patient driven diabetes solutions under #WeAreNotWaiting initiatives. Notably, the NightScout CGM in the Cloud project. FDA is to be commended for their openness to talking with representatives of this ad hoc effort.

– The efforts of FDA’s consumer representative, Rebecca Killion, is an excellent example of the value a patient can bring to the regulation process. As a member of ADCOM panels, she is a champion of patient views.

– I hope that the dialogue between FDA and people with diabetes continues to grow in both content and diversity in 2015 and beyond. I hope that the #DOCasksFDA process leads to a unique and meaningful PDUFA meeting on diabetes.

Finally, I believe that

  • The patient perspective is unique, and should be included whenever the FDA reviews drugs and devices.  This is the most important part of interaction.  No one can understand diabetes the way those who live with it do.
  • Including the patient viewpoint can reduce the time spent gathering information for both reviewers and submitters.  It can help provide a fresh set of eyes on impactful changes to devices and drugs.
  • Having a patient as part of the process focuses concerns and speeds approval of meaningful improvements.  We’re able to ask questions and provide real-world experience of why something works for the patient, and why it doesn’t.
  • Under MDUFA III, the Patient Preference Initiative is critical to give FDA a meaningful look into how people with diabetes consider the benefit/risk paradigm regarding new devices under review.
  • The idea of a person with diabetes, or a parent of a child with diabetes serving as a Special Government Employee, such as Ms. Killion, is extremely beneficial.


 
 
I know I’m asking a lot, asking you to help with this right now. Think of it as a way to get one more ounce of advocacy in before Diabetes Awareness Month is over. And we need your advoacy. The best part is, you don’t have to even leave your home. If you’re reading this right now, you can make a difference right now. Let’s not only not lose this opportunity… Let’s make the most of this opportunity before it’s gone.

On behalf of myself and all People With Diabetes, Thank You.

Special thanks to Bennet Dunlap, Christel Marchand Aprigliano, and the rest of the Strip Safely team for their help with this effort.
 
 
 

By StephenS | Posted in Advocacy | Also tagged , , | Comments (9)

FDA Workshop– I came, I saw, I listened.

November 17, 2014 – 10:58 am

FDA

I mentioned last week that I would be attending the public workshop at the U.S. Food and Drug Administration, titled Regulatory Science Considerations for Software Used in Diabetes Management.

It was a pretty full day.

Remember, this was a day off from work. You know, that thing I do to make money so I can actually attend these things in person. I woke up earlier than I do when I actually go to work, and instead of leaving the house between 7:00 and 8:00, driving a mile and then getting on a train, I left at 6:00 and drove to FDA headquarters in Silver Spring, Maryland, over an hour away through almost rush hour traffic.

The proceedings started at 8 a.m., and the day started with presentations related to something that I’ve really taken notice of this year: Interoperability.

When I go to meetings and workshops where a lot of presentations are made, I try to go over each person’s message and convey that to you here. This time, I’m not going to do that. Instead, I will refer you to the webcast replay that’s available over at the FDA’s website, where you can get video, audio, and presentation slides. I will, however, share a little of what I experienced on that day.

I always learn a lot when interoperability is discussed. It’s such an interesting subject to me, and it’s an idea that’s long overdue in the diabetes world. I didn’t expect to get much out of the bolus calculator presentations, but I was wrong about that. The talks were very good, and the panel discussion at the end was great to see.

The presentations were all informative and interesting. Particularly, those from Howard Look of Tidepool, who made an excellent presentation, making the case for interoperability based on the simple fact that we need to reduce the burden of diabetes on the patient, and interoperability would most definitely be a step in the right direction. Dr. Joe Cafazzo talked about the research his team is doing in Toronto, working to understand and map out a strategy for a standard of device data interoperability. As someone in the Q & A session mentioned (a corporate representative in the room), think about when you purchase a lamp and it has the UL symbol, or think about how HTML is the standard code throughout the internet. If we can arrive at a standard for diabetes devices, it might make it easier for a company to deliver trusted product to consumers (us), and then market it by saying it meets the standard.

Adam Brown of diaTribe was fantastic speaking about insulin bolus calculators, how they work, and what the impacts of bolus calculators are to people living with diabetes, backing everything up with lots and lots of supporting data (the FDA really likes that). Dr. Howard Wolpert from Joslin Diabetes Center and Jane Seley of New York Presbyterian Hospital gave fact-based talks that confirmed the anecdotal stories they shared about dealing with diabetes patients on the front lines over the course of many years of service.

The panel discussion surrounding bolus calculators was interesting. Most of the discussion had to do with the many bolus calculator apps that are out on the market now. While a calculator within my insulin pump must be approved by the FDA, apps that perform the same function do not right now. The moderator of the panel was convinced that these bolus calculators should be regulated. Adam Brown and Howard Wolpert made a convincing case (in my eyes, anyway) that, in Adam’s words, “a patient using a bad bolus calculator is still better off than a patient just winging it”.

At the end, Dr. Courtney Lias (look her up) shared a few things with us. She appreciated everyone’s viewpoints, and indicated that the FDA intends to continue the discussion. Not sure how yet, but they are willing to commit to having more discussions in the future on these subjects. What is not on the table: Restricting bolus calculators. The important thing, she said, is that the FDA get the right touch between innovation, patient safety, and the idea of benefit vs. risk for people living with diabetes. She reminded us that the patient is key… safe, effective tools to manage diabetes is everyone’s goal… and one person’s diabetes is not like another’s, so not every solution will meet the needs of every PWD.

In addition to all this, I got to sit down at lunch with a person working on the Nightscout project, and with another industry representative. It was great getting a chance to share my story with them firsthand (though I’m not using Nightscout—or a CGM right now).

And during the public comment portion of the proceedings, I was allowed to speak…

Photo of my best side courtesy of Bennet Dunlap

Photo of my best side courtesy of Bennet Dunlap

I’m usually a good public speaker. I enjoy getting up in front of people and talking. This, however was not my best performance, though I think I got my message across. It was basically the same thing I published here earlier. You’ll probably be better off if you go to that and read it to yourself, rather than listening to my ramblings.

Anyway, there were a couple of people left to speak after I was finished, and while I sat there listening to them, something strange happened. I was almost overcome with a wave of emotion. I started to ask myself “What did I just do?” and “Four years ago I wasn’t involved in anything outside of my own neighborhood… How did I get here?”.

I think it was just a feeling that I had something to say, and I said it, and damn anyone who might try to belittle it. Including you, industry representative on the aisle who gave me that sour look as I walked back to my chair. I understand that companies want to advocate for what’s in their best interests. Well, that’s what I was doing too. Advocating for what is best for me as a patient. I understand and respect their concerns, but when they clash with what I need and deserve as a patient, I’m going to advocate for me and not be sheepish about it.

In the final assessment, I can say it was a day in which I was able to learn a lot, meet new people, and share my needs with the federal agency that plays such a big role in our lives. All of that made it well worth losing a little sleep and schlepping to D.C. in the dark. The timing (November 13) made it feel like an early World Diabetes Day gift.
 
 
 

By StephenS | Posted in Advocacy | Also tagged , , | Comments (3)

Happy World Diabetes Day, Advocates. I’m looking at you.

November 14, 2014 – 9:49 am

So here we are. World Diabetes Day, 2014. And everyone’s burned out.

Sorry to throw cold water on a day when we should all be showing our true diabetes selves to the world. But hey, the burned-out part is part of our diabetes selves, isn’t it?

It is. There are also soooo-oo-ooooo many initiatives out there right now that even energetic-little-old-me is feeling overwhelmed. And that’s what I want to talk about.

Because I think there’s a difference between feeling burned out and feeling overwhelmed. Burned out is “I’ve done all these things and I’m so tired and I just can’t muster the energy for one more task”. Plus “I’m tired of doing all these things and seeing no outward result”. Completely understandable, and believe me, I’ve been there.

On the other hand, overwhelmed, to me, is “Big Blue Test”, and “Dexcom Share has been approved”, “#Vote4DM”, and “#MedicareCGM”, “Blue Circles” and “Diabetes Awareness Month” and “National Diabetes Awareness Month” and “National Diabetes Month” and “Where do I start?”. Again, I totally get it. It’s hard to keep up with everything and give 100 percent effort to all the things.

It’s even possible to feel burned out and overwhelmed at the same time. Plus, the magnitude of this month in addition to the big things people are doing has a certain way of making the rest of us (and what we’re doing) feel kind of small by comparison.
 
 
So let’s take a deep breath. Find some perspective.

Let’s acknowledge a few diabetes truths here:

– If you’re living with diabetes, or helping someone who lives with diabetes, You Are An Advocate. That’s true if you’re in your first year or your fiftieth. Or sixtieth. Or… you get the idea. Pat yourself on the back every day. You deserve it.

– If you’re telling your story by writing a blog, shooting a video, tweeting your #WalkWithD, participating in the 24 hour #WDDChat2014 today, or engaging with your diabetes brothers and sisters via Facebook, Instagram, Tumblr, or any other social media outlet, You Are An Advocate.

– If you’ve mentored another person living with or affected by diabetes, either online or offline, whether anyone was looking or not, guess what? You Are An Advocate. Extra points if you picked someone up who was feeling defeated by this disease.

– If you’ve ever set the record straight for someone who didn’t know better, dispelling myths and taking back your dignity, whether anyone was looking or not, guess what? You Too Are An Advocate.

– If you’re living with diabetes and pursuing your athletic goals through adversity and despite the extra toll it takes on your psyche and your blood sugar, You Are An Advocate.

– If you’re a woman who has lived through both diabetes and pregnancy, You Are Most Definitely An Advocate. And Congratulations Jen and Kelley and Elizabeth.

– If you’re a Mom or a Dad who is raising a child at the same time you’re managing your diabetes, or you’re a Mom or Dad raising a child living with diabetes, gosh, I have such admiration for you, and by the way, You Are An Advocate.
 
 
There are many ways we show our advocacy, and it doesn’t always have something to do with the latest D-cause. Often, it has to do with the examples we set by living our lives with diabetes, rather than having our lives ruled by diabetes. There are no levels of deserving. You are just as worthy of my respect and admiration as anyone ever cursed by this chronic condition.

So while you rest up from your diabetes burnout and your diabetes-advocacy-event overload, remember to acknowledge the amazing ways you’re already making a difference. Write a list of your advocacy accomplishments. Look at it whenever you need a boost. If you want, you can leave a comment listing them here, either with your name or anonymously. I’ll bet when you do, you’ll find a lot to be proud of. Know that I and many others are proud of you. And grateful.

Thank You.

And please remember: I support you… no conditions.
 
 
 

By StephenS | Posted in Advocacy, World Diabetes Day | Also tagged , , | Comments (6)