Tag Archives: Strip Safely

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)

Reminders, reminders. And more reminders.

October 29, 2014 – 9:31 am

Here are a few reminders of things happening right now where you can make a difference:
 
 
Tweet your elected officials! Tell them to #Vote4DM!

VOTE4DIABETESM

Maybe you were getting ready for last week’s DSMA Twitter chat and you started noticing all of the tweets going out from the Diabetes Community to House members and Senators here in the USA. Do you know where that started? It started at Strip Safely, who started the campaign and even provided this nifty web page that made it super easy for people to Tweet their elected officials about coordinating the federal response to diabetes, covering CGMs for senior citizens on Medicare, and permitting Certified Diabetes Educators to provide already approved education benefits to their patients.

Guess what? There will be a brand new Tweet-In again tonight (October 29) beginning at 8:00 p.m. eastern time. Once again the Diabetes Community will be showing strength in numbers by massively tweeting the lawmakers we elected and letting them know how important it is (less than a week before election day) to make diabetes an integral part of the legislative landscape. And soon.

It will take less than five minutes for you to be an advocate.

At 8:00 eastern time tonight (US)– You can help by going to this page, finding your congressperson and senators, and clicking on the specific links listed to either encourage the people (that we elected) to take up the cause, or to thank them for already doing so.

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Five days until #DOCAsksFDA

I’m very much looking forward to the conversation (via webcast) that will be taking place on Monday, November 3 beginning at 1:00 p.m. eastern time (US). This is a chance for you to learn more about the U.S. Food and Drug Administration, how and why they review devices and drugs, and how we, as a community, can work with the FDA toward better outcomes in all areas.

To RSVP for the webcast, go to this Diatribe link or this FDA link, get all the information, and register. Once you’ve done that, you’ll get a look at the agenda and a link to join the webcast on Monday. I hope you’ll be there!

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Don’t forget about the Big Blue Test

Hashtag-Big-Blue-Test

The Big Blue Test is going strong. As of this writing, there were over 1600 Big Blue Tests recorded so far. But that’s a far cry from the goal of 35,000 set for this year’s event.

Don’t forget… Now until November 19, every Big Blue Test that is logged will result in a $1.00 (US) donation to non-profit diabetes groups that are working tirelessly to provide education, support, and supplies to people who need them. My guess is maybe you’ve forgotten to log all of your activity. Well what are you waiting for?

Here’s how it works:

1. Test your blood glucose. If you do not have diabetes, you can skip this step.

2. Get active. For 14 to 20 minutes, get up and get moving. You can , walk, run, clean the house, swim, tap dance…whatever!

3. Test again. On average, Big Blue Testers seen their blood glucose level drop 20% after 14-20 minutes of exercise.

4. Share your results. Answer the questions in the right column of the page at bigbluetest.org. And don’t forget to talk about your experience on social media using the hashtag #bigbluetest.
 
 
 
So there you have it. Three great ways to learn, stay active, and hold congressional feet to the fire for People With Diabetes. It’s not always about big projects with huge budgets and lots of manpower. Sometimes it’s as simple as saying, “Yeah, I can do that” and making a small effort.

And while I’m at it, let me say: Thank You for your advocacy. Your efforts continue to make a difference.
 
 
 

By StephenS | Posted in Advocacy | Also tagged , , , | Comments (1)

Talking with the FDA.

September 19, 2014 – 6:17 pm

This post is also published on the Diabetes Advocates website.
Take the Diabetes Advocacy Survey, join us, and become a Diabetes Advocate right now. This post will wait until you come back.

When I first discovered the group of bloggers, reporters, healthcare professionals, and patient advocates that make up the Diabetes Online Community, I remember feeling really good about the support and encouragement I was suddenly finding through the internet.

I did not know much about the U.S. Food and Drug Administration, other than knowing that they had to approve every new drug or device used to help me survive with diabetes. Then I started reading a lot from people who felt that the FDA was holding back progress on these things. How the FDA never took the patient point of view into consideration. How they were a bottleneck, holding back advancement toward better outcomes for us.

Well, I’m not sure if that was entirely true then. But I do know now that it is not true today.

Last year, Strip Safely helped lead a campaign to get more people to comment on FDA draft guidance for glucose meters. We were all encouraged to post comments letting the FDA know how important greater accuracy and post-market inspection is when considering the trustworthiness of new glucose meters and test strips.

We were able to post those comments directly to the FDA because they made it possible to do so, easily, online. As a result of just that one push to comment, the FDA received six hundred comments on this one issue. That’s about six or seven times the number of comments they generally receive on draft guidance. Collectively, and as individuals, the diabetes community spoke and the FDA listened. But that’s not all.

A few weeks ago, I received an e-mail from the Food and Drug Administration about comments I left regarding glucose meters in a point-of-care setting (hospitals, doctor’s offices, etc.). They wanted to speak to me about what I had written them. So we scheduled a time, and I spoke by telephone with Katherine Serrano, Deputy Director of the FDA’s Division of Chemistry and Toxicology Devices.

We talked about some of the things I had written, and she had a few questions for me. The thought of that seems a little intimidating at first. But rather than just a talk between a Deputy Director at FDA and a guy from Baltimore, it was really a conversation between two people discussing an important topic. I tried to give her my passionate best on the subject, and she remained engaged, asking follow-up questions and allowing me to consider her questions carefully before answering, and even letting me e-mail her later with additional feedback. This does not seem like the actions of a group that does not care what we think.

I don’t know how seriously Ms. Serrano or the FDA considers my views on the subject. But there’s no denying the fact that I was given not one, but two chances to deliver a personal plea for the best possible device guidance on point-of-care glucose monitoring. And I was not going to pass on either one of those opportunities.

Because new innovations often take years to get into the hands of the people who need them most, it’s easy to feel like your voice would get lost among the masses, even when you do take the time to respond to something. But what’s the alternative? You, or people you love, are the patients, the ones most affected by any changes to the status quo. The one way to be sure your concerns are part of the public record is to make them public. The one way to help all people with diabetes get the better outcomes they deserve is to insert your voice into the conversation. And if you’re asked for additional perspective, be sure to speak with the passionate desire for the absolute best results that comes with the perspective that only you possess.

We’re counting on you. Allow yourself to be the voice that makes the difference.
 
 
 

By StephenS | Posted in Advocacy | Also tagged , , | Comments (5)

Like these links, and keep the D-mojo going.

August 6, 2014 – 8:48 am

Welcome to Wednesday…

I’m going to throw a few links at you today to help you keep your diabetes mojo going strong. I promise: If you click on any of the links below, your requirements in terms of time and effort will be a scant two or three minutes apiece. Quicker if you read fast. Check them out:

You may remember me writing about a U.S. House of Representatives resolution (HR 3710—Medicare CGM Coverage Act) introduced last year. Well, now a bill to get continuous glucose monitors (CGMs) covered by Medicare is making its way through committee in the United States Senate. This one is Senate Bill 2689—Medicare CGM Access Act of 2014. Introduced by Senate Diabetes Caucus co-chairs Susan Collins (R-ME) and Jeanne Shaheen (D-NH), this bill aims to do the same thing: Protect the right of citizens on Medicare to keep their CGM. Make sure you get your senator to get behind this legislation, like, NOW. JDRF makes it easy by providing this link:
https://secure3.convio.net/jdrf3/site/Advocacy?cmd=display&page=UserAction&id=412

Just fill out the form, include your own personal sentiments (like, “I’m going to be Medicare eligible in 13 years… Don’t take away my CGM when I need it most!”). Click Send Now and you’ll have committed an act of Diabetes Advocacy before Starbucks can serve up your latte.

Got an extra minute? There’s also a petition to sign:
http://www.thepetitionsite.com/takeaction/776/978/446/

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Also: The U.S. Food and Drug Administration has proposed new guidance for Medical Device Data Systems (MDDS). Borrowing from the Strip Safely website:

“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.” Translation: technology that lets data show up on a device other than the medical device itself. FDA believes that these types of MDDS introduce little additional risk, and the agency is therefore proposing to lessen the regulatory process for MDDS.”

Face it: We would all like to have access, and provide access for our loved ones, to the data from our devices. This is possible, it’s helpful, it’s an idea whose time has come. Agree? Now’s your opportunity to have your voice heard. How do I know they’ll listen? I was contacted by the FDA about comments I posted earlier last year on glucose meter accuracy and post-market inspection.

You only have until August 25 to submit your thoughts. Get the skinny right here:
http://www.stripsafely.com/sample-page/comment-on-mdds/

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Finally… Just in case you forgot about it, don’t forget about the first Diabetes UnConference, taking place out in Las Vegas next March. Brainchild of Christel Marchand Aprigliano of ThePerfectD, it will be a conference of diabetes peers from all over, setting the agenda together in the first hour, and asking and answering questions throughout the weekend. I already have four ideas, at least one of which may have some merit. If you’d really like to attend a diabetes conference by People With Diabetes, for People With Diabetes, this might be for you. I understand rooms are filling up fast. This is really turning into a thing. Find out more about the Diabetes UnConference and register too by going to:
diabetesunconference.com

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So… what about you? Have you read or written anything lately that is awesome? Oh… I just remembered: Kelley at Below Seven just published this month’s list of Best of the ‘Betes blog posts yesterday. Now… Where was I? Oh yes… If there’s something that moved you recently, please be sure to leave a link to it below. I’d love to read it!
 
 
 

By StephenS | Posted in Like these links | Also tagged , , , , , | Comments (1)

I’m looking at you…

April 30, 2014 – 9:06 am

I’m looking at you… you person, who has up until now procrastinated and not submitted comments on blood glucose meter and test strip accuracy to the U.S. Food and Drug Administration.

You have one week left.

SSGuidance

For one more week, two draft guidance documents are open for comment from the community at large. One is for equipment used in a clinical setting, like doctor’s offices and hospitals. The other has to do with the meters and strips we all use as consumers (read: patients).

Due to enthusiasm from the Diabetes Community, the FDA has added an extra month to their deadline for people to leave comments on these important documents. But that extra month ends next Wednesday.

Have you commented yet? (Hint: you don’t even have to be a person with diabetes to comment)

Have you spread the word about this important draft guidance?

Is the answer c) None of the above?

Don’t worry. The important information on the draft guidance, and how to leave comments, and even some sample text you can use when commenting, is all available on the Strip Safely site.

Let’s say you’ve left comments already. Well… Have you read the information about third party strips documented so well at Strip Safely and over at Diabetes Mine?

Did you know you could add additional comments expressing your concern over third-party accountability? Guess how long you’ve got to do that? That’s right… one more week.

Don’t miss out on lending your voice to this important issue. It is needed and wanted and appreciated. So please, take this not-so-gentle reminder to heart, and help ensure better accuracy of the glucose meters and test strips that are used multiple times every day. Time is running out. Procrastination is not an option any longer.

Many thanks to Christel Marchand Aprigliano and Bennet Dunlap for leading the charge up the Hill of Guidance.
 
 
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By StephenS | Posted in Diabetes | Also tagged , , , , , | Comments (1)
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