A message from diaTribe’s editor Kelly Close

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Kelly Close if you don’t know is a tireless diabetes advocate and on the front lines of diabetes information and its dissemination. A highly respected financial analyst, as well as someone who’s lived with type 1 diabetes for more than 25 years, Kelly runs Close Concerns and keeps an eagle eye on research, product development, pharma and the FDA.diaTribe is her free every other month e-newsletter. 

The July issue had a message from Kelly I wanted to pass along. Given the FDA’s risk-averse policy to new drugs and devices, many products that could help the many linger and languish. Kelly’s inviting any and all of us to chime in to the FDA at their public hearing August 11th. Here’s the article below and here’s the plea: please email us on what you would like the FDA to know at: 

We want our diabetes treatments to be effective, but we also want them to be safe, and it is up to the FDA to decide if the benefits of a given medication outweigh the risks. Our concern, is that the pendulum has swung too far in favor of caution and safety at the expense of innovation. Much-needed new products are being delayed or even shelved entirely. the good news is theta FDA will be considering these risk-benefit tradeoffs at a meeting in August, and you have a chance to make your voice heard.

Determining whether a new diabetes drug should be approved has never been easy, but the turning point in this debate occurred in 2007, when Avandia was implicated for apparently increasing the risk of heart attacks. The FDA revised its guidelines so that drug companies would need to demonstrate cardiovascular safety before approval, adding huge costs to the process ($100 – $300 million). The FDA tried to ease this burden by allowing the companies to submit so-called interim data, or data midway through the cardiovascular (CV) trial that demonstrated safety, and the companies could complete the trial after the d rug was approved.

Unfortunately, that hasn’t worked out too well. Once the drug has been approved, participants want that drug and are motivated to abandon the trial. It’s logical behavior, but it negates the very costly study.

The result? Companies are giving up on diabetes. Bristol-Myers Squibb left diabetes entirely in 2013, and Genentech is out too. The cardio trials can delay drugs (like degludec) and follow up drugs (IDegLira) for years. Takeda said it won’t develop its once-weekly DPP-4 inhibitor in the US because trials are too expensive, while delays with Sanofi’s GLP-1 agonist Lyxumia slowed development of entire new classes of diabetes drugs.

In sum, there are benefits to the trials, but we believe we are sacrificing innovation at the altar of safety. (And by the way, Avandia was ultimately found to be safe).

The FDA is holding a public hearing on August 11 to discuss how to address interim data in trials. This is a real opportunity for our community to make our voices heard. Registration to attend is open until July 28; those who can’t make it to Silver Spring, Maryland, can submit a comment right here at Kelly@diaTribe.org. Every comment submitted before July 28 will be considered, but you can submit all the way up to October 10. We would love to thank the FDA for giving patients and families and healthcare providers the option to comment. 

When our response is ready, we’ll tweet it and make it widely available – we’re working on it now! This issue is complex, and it’s only part of a much larger question about how we should handle drug development and approval. But for now, let’s tell the FDA that the status quo isn’t working. We also look so forward to following up November 3 in a conversation with FDA – read our new now next for more on this!

very best,


Medicare’s cost-slashing for test strips creates a DOC movement: Strip Safely

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StripSafely is the Diabetes Online Community’s raised voice to protect ourselves from inaccurate blood glucose meters and test strips.

This month Medicare begins offering a limited variety of glucose meters to its beneficiaries. Many of the test strips offered, and manufactured overseas, fall below the FDA approved standard for accuracy. That standard is already too low but don’t get me started.

I’m asking you to join the movement. It’s easy. Write a letter (samples provided) asking the FDA to ensure strip accuracy. If you have diabetes, know someone who does or love someone who does, you know this is a life and death issue.

And while you may think this doesn’t concern you because Medicare is a lifetime away, this may drive US manufacturers of meters and strips out of business. That means: no quality control, innovation, support services, educational programs, and oh yea, accuracy.

It only took me 15 minutes to write my letter. Here are sample letters to make it easy. And here’s mine. As you can see, I took the sample “Short Letter” and just made it personal.

Jeffrey Shuren, MD JD
Director, Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue, WO66-5442,
Silver Spring, MD 20993

July 2, 2013

Dear Dr. Shuren:

I’ve had type 1 diabetes for 41 years and I’m turning 60 next month. Two weeks ago my A1C was 5.5%, yes, normal. How is that possible? I adhere to a healthy diet, exercise every day, and check my blood sugar diligently using a meter and strips recognized among those with the tightest accuracy.

I am writing to you because while I might have said as a teenager, “I’d die if I don’t get that!” I actually could die if I don’t have accurate test strips.

Those of us living with diabetes truly need your help and advocacy. We are facing losing our health due to Medicare’s July 1st cost-slashing program. In only a few years I will be affected by this if nothing changes, and meanwhile US manufacturers may get squeezed out of the market due to price. That means we will lose further quality control and standards, innovation, new product development, service support and educational programs.

At a recent meeting with the Diabetes Technology Society, the FDA acknowledged that many blood test strips do not deliver the accuracy for which they were approved. Further, the FDA has no plan to fix this problem.

I need you to have one. My Aunt needs you to have one, my downstairs neighbor needs you to have one, and hundreds of my friends and acquaintances need you to have one. And my husband, who doesn’t have diabetes, desperately needs you to have one. Otherwise, one day he may not have me.

Blood sugar fluctuates all day, every day both as a consequence of what we do, and by its own nature. I don’t need the quality of test strips to also be uncertain.

Please, I am asking you to, at the least, implement a program of ongoing random sampling of strips to insure that all brands consistently deliver at least the minimal accuracy approved by the FDA.

While I have previously written that the FDA should tighten the ISO standard, how wonderful it would be if Fixing Diabetes Accuracy is one of the things for which the FDA becomes known.

Riva Greenberg

Don’t wait. This is something we can do together. And lives depend on it. Feel free to copy my letter, just fill in your own specifics.

Thank you

Spare a Rose, Save a Child, Share the love

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Several in the DOC (Diabetes Online Community) including Kerri Sparling, Kelly Close, Manny Hernandez, Bennet Dunlap, Adam Brown and Jeff Hitchcock have joined up with Johnson & Johnson to help raise funds forLife for a Child, the International Diabetes Federation’s humanitarian program that gets life-saving supplies, education and care to children in need in developing nations.

The initiative is called “Spare a Rose, Save a Child” and here’s how it works. Instead of buying a dozen roses this Valentine’s Day for your amour, buy 11 roses and take the savings from that one rose and contribute it to IDF. Kind of a win-win-win. Your loved one gets a beautiful bouquet of roses, a child gets help to live and you get the joy of giving twice.

The program is occurring all this week from February 10-16th. Just make your donation here. In the spirit of Valentine’s Day, spare a rose, save a child and share the extra love you’ll feel with the lucky one who already has your heart. 

Your old cell phone can buy life-saving, in time, care

Chelsea Clinton wants your phone!

This is such a great cause. Chelsea Clinton and supermodel Christy Turlington Burns have started an action at George Washington University – that you can be part of – to collect old cell phones so women in Congo and Nepal can get critical care fast. 

Money from the sales of your recycled phone will be used to buy new phones and given to women in developing countries so they can get vital information from far-away health care providers and connect for critical hands-on care in life-saving time. It’s about taking an old cell phone and creating a health care infrastructure where none exists. 

Your donated phone will generate two to three new cell phones. Smartphones can yield five to 20 cell phones. 

To donate your phone, ipad, ipod, digital camera or other mobile devices,register here, fill out the ticket Information, click “Register” and you’ll be led to a registration page. Fill it out, click “Complete Registration” and you’ll be led to a page that says “Order Confirmation.” Click on “Hope Phones mailing label” and you’ll be provided a Prepaid Shipping label to affix on a padded envelope and drop in the mail. 

The postage is free, the padded envelope is on you. 

In these days of all bad news all the time, this is a great way to make a huge difference in the lives of others.

Ann Keeling, CEO of IDF, talks about the urgency of September’s UN Summit

YouTube video

Yes, as you can see this UN Summit has caught my attention, my humanity and my advocacy. 

What greater opportunity do we have than this event scheduled for world leaders to come together and create targets and tangible actions and outcomes for reducing non-communicable disease by 25% by 2025? 

If you still don’t understand why it benefits all of us to reduce the global impact of non-communicable diseases, Ann Keeling gives an impassioned interview to Manny Hernandez.Watch it and you will.

September 19th’s UN Summit hits an upset

I seem to keep saying, “If you read my last post…” but this is a story that keeps growing. The International Diabetes Federation (IDF), who are driving a campaign to get President Obama to the first-ever high-level UN Summit to contain and eradicate non-communicable diseases (NCDs), the top 4 of which are: cancer, heart disease, chronic respiratory and yes, disease – now cites a stand-off getting U.S. and European Union representatives to commit to outcomes and timelines. 

The IDF issued a press release early this morning that some UN member states are jeopardising international progress by trying to postpone and weaken United Nations negotiations.

The press release goes on to say, “Of particular concern are the actions of the U.S., Canada and the European Union to block proposals for the inclusion of an overarching goal: to cut preventable deaths from NCDs by 25% by 2025.

As Jacquelyn Beals, PhD writes at Medscape News in “UN Summit on Noncommunicable Diseases Hits Snag”negotiations over an outcomes document for discussion at the Summit have hit a wall, with the United States and the European Union opposing many of the target-oriented resolutions on the grounds that they would be responsible for the bulk of the action items. Because developed nations would foot much of the bill for combating NCDs, they are reluctant to commit to time-bound targets in an uncertain economy.

Brian Ward, policy advisor for the European Respiratory Society, says in the article, “Despite the fact that the NCD burden is highest in Europe and the United States, these regions have also been very reluctant to commit any financial support to this UN process aimed at tackling the NCD epidemic.”

President of IDF, Jean-Claude Mbanya, MD, PhD, who will address the delegates at the European Association for the Study of Diabetes Annual Meeting on September 13, says we have the evidence cost-effective solutions are available and with the Summit we have the political opportunity.  

With President Obama engulfed in the U.S.’s financial woes it’s easy to say let’s concentrate our attention and finances on jobs, yet something else he said early in his presidency is healthcare will bankrupt us if it, and we, don’t change.

Ann Keeling, CEO of IDF and chair of the NCD Allianceand CEO of IDF, which groups some 2,000 health organisations from around the world focused on non-communicable diseases says rich nations are reluctant to foot much of the bill for tackling a chronic disease epidemic in poorer nations, and are reluctant to commit to this when their economies are in turmoil. But such fears are short-sighted.

So which comes first? Put our money toward helping people around the world, and here, to achieve better health in order to halt health care costs from bankrupting us and halt non-communicable diseases from impeding global progress and devastating the world economy or ignore the state of the world’s health and pay later? 


Send a postcard urging President Obama to attend the UN Summit on diabetes next month

If you haven’t heard, September 19-20 Heads of State around the world are meeting for the first-ever High Level Summit on non-communicable diseases. Diabetes is one of the four devastating illnesses putting our health – individually and as a nation – and our economy and future in peril.

On the Huffington Post this week I write about the International Diabetes Federation’s Postcard Campaign to get President Obama to the summit – and commit to improving resources and treatment for diabetes and halt the epidemic here and around the world. 

Please take a moment to send your postcard. You may end up changing all of our future.

Big Blue Test earns two Telly awards!

Last year Manny Hernandez founder of Diabetes Hands Foundation, David Edelman founder of DiabetesDaily.com and me, along with venerable producer Sean Ross, created the Big Blue Test video which was awarded the 2011 silver (the highest honor) and bronze Telly awards – respectively in the online programs regarding social issues and health and wellness categories.

If you were one of the 133,674 views the video received, you know the video promoted the benefit of exercise to manage blood sugar. Specifically, taking the Big Blue Test – doing just 14 minutes of an activity and seeing your blood sugar come down. Thousands of people saw their blood sugar lowered on average 20 points. Each view of the video also made possible a donation of $75,000 from Roche to two diabetes charities that sent life-saving insulin and supplies to children in need around the world.

This year Manny, David, Sean and I are back in the saddle, as is Roche, to create another big blue test video. Look for it this November, diabetes month. 

By the way, you don’t have to wait till November to see the benefit of 14 minutes of activity. Why not do it today? Then come November, join the thousands who will record their 14 minutes of activity on the Big Blue Test site (which I’ll be sure to tell you about) and work toward saving your own life, and that of a child in need.


Meet Ginger Vieira: Creating a big footprint in the DOC

Ginger Vieira


 Ginger Vieira, 25 years old, has lived with type 1 diabetes and Celiac disease for almost 12 years and is creating a large footprint in the DOC (diabetes online community). Ginger is a champion-winning power lifter, personal trainer, yoga instructor and inspirational video blogger, recently adding dLife to her credits

Her young life and work speak to building a life of accomplishment, regardless of and in many ways due to diabetes, and using it to help others.

I also interviewed Ginger specifically about her book, “Your Diabetes Science Experiment” for theHuffington Post“A Diabetic Athlete Shares How To Minimize High And Low Blood Sugar.” 

Q: Do you remember your reaction when you got diabetes 12 years ago, at the age of 13?

Yes, crystal clear! After bursting into tears I asked the doctor if I was going to die. I had absolutely no idea what diabetes was. I spent three days in the hospital, and at first I felt really sorry for myself. Why me? But I started thinking about all my friends and some of the tremendous things they’d been through already – brain tumors, losing parents to cancer, hemophilia, depression, leukemia – and I realized that everybody has at least one kind of immense challenge in their life, and diabetes is one of my challenges. I left the hospital with that attitude and I still carry it with me. Nobody has it easy! So I don’t deserve to feel sorry for myself just because I have type 1 diabetes.

Q: Had you a plan for your future already at age 13 and did you wonder if you could still do it?

Well, I have always, always been a writer. Even in the second grade I was in love with writing. I wrote two different series, one was about my pets and their adventures, and the other was about a girl who grew up in a big family with too many boys in it (my real life!) and they were always getting in her way and screwing things up.

Q: What don’t most people understand about diabetes?

That taking shots and pricking your finger is actually the easiest part. People always say, “Oh my gosh, I can’t believe you do that every day.” It’s really everything else that makes this disease so incredibly complicated. Seemingly simple things like going for a long walk, sleeping in and missing breakfast, trying to concentrate when your blood sugar is too high, trying to have energy at work as a personal trainer when your blood sugar is recovering from being too low!

And the way this disease weighs on your emotions. It impacts how you think about exercise, food, friends, relationships, etc. It impacts literally every single part of your life and I will never expect a non-diabetic to truly understand that because it is so immense.

Q: You’ve set 15 records in power lifting. Did having diabetes motivate you to become a power lifter?

They were really separate goals at first. I joined a gym originally because I wanted to get in better shape and after a year of basic weight-training I’d gotten pretty strong! But when I told my doctor that I was thinking about going into powerlifting, he rolled his eyes. I wanted to prove him wrong and show other people with diabetes that anything is possible. I’ve never been much of an athlete when I was younger, so you can’t chalk it up to incredible genes or something. It is pure determination and persistence.

Q: You’ve done a number of YouTube videos and what’s apparent is your optimism. Do you have difficult days with diabetes and if so how do you get through them?

To be honest I don’t have days where I hate diabetes. Ever. It doesn’t occur to me to get mad at something that is simply part of my life, but that’s because I’ve developed and strengthened the attitude I have towards this disease. I can’t make it go away, so why am I going to waste energy hating it? That would feel like a waste of energy to me.

I also really don’t expect myself to do this perfectly. I don’t beat myself for having high blood sugars sometimes. I’m human, I absolutely cannot attain perfect blood sugars 24/7. So I give myself room to make mistakes, while also expecting myself to give my best effort.

Q: Your business is called “Living in Progress.” Tell me about that and why you call it that?

Coming up with the name was easy because I really believe that we are all constantly evolving. Wherever you are in your life, in how you think about your health and yourself right now, does not and will not be how you think about it even just a year from now. If you want to change something about your life and your health, it doesn’t have to happen overnight. It can be a very gradual progress and sometimes it happens without you even realizing! I’ve seen these evolutions in my own life many, many times.

I work with people one-on-one across the country, over the phone, on goals like making exercise a regular part of your life, improving your nutrition habits, rebuilding self-esteem, developing healthy coping habits, diabetes life management, and emotional eating. Everyone comes with their own specific goals.

Q: How can people shift their view to get away from being so fault-finding and being impatient with themselves and see their life more as a “work in progress?”

Well, that change won’t happen overnight, and it’s a process, but I believe the first and most important step is to really acknowledge where you are right now. To really describe and dig into how you are treating yourself, how you are talking to yourself, what kinds of limiting beliefs you have about yourself.

What has helped me the most in my own evolution is giving myself room to fail, room to be imperfect, and I really, really believe in gradual steps. When I started weightlifting, for example, I had no intentions of becoming a competitor. I grew into that place because I just focused on doing the best I could in the things I enjoyed the most.

Q: You’ve just begun working with dLife as the “Community Leader & Social Media Manager.” What does that involve and what do you hope to create for others?

For starters I’m going to be making video blogs for them with the same energy you’ll find in my own YouTube Channel video blogs. But I’ll also be connecting with people, talking about diabetes in a real way because I live with it in my real life, and providing support, knowledge and encouragement through dLife’s outreach and the many, many resources and information. It’s about support and empowerment.

Q: Who is your book, “Your Diabetes Science Experiment” meant for and what is it you want most for people to take away from it?

The book is for anyone with Type 1 or Type 2 diabetes who wants to learn more about insulin sensitivity, insulin resistance, how proteins, fats and carbs impact the human body with diabetes, and how to adjust your insulin doses for meals and exercise. I also help people understand how to make changes in their diet while adjusting insulin needs to prevent low blood sugars, and I break down how different types of exercise impact a body with diabetes.

The biggest thing I want people to take from this book is that when your blood sugars are high or low, there is a logical reason. And in many cases there really is something you can do to prevent those fluctuations from happening again. You just need more information than what you’re usually getting from the hospital or your doctor.

Q: You say in the beginning of your book that you could probably fill another 500 pages with how much diabetes impacts your thoughts and emotions. Can you give us a little preview of that here?

This disease is 24 hours a day, 7 days a week. There is no way that it isn’t going to affect the way you think. My next book will really bring to light the many aspects of life that diabetes impacts, to help people not only become aware of them in their own life, but also how to work through them. I believe we control how we think. Just as we control whether or not we choose to be offended when someone says something unkind to us, we control how diabetes impacts the way we think about food, exercise, and ourselves. But you have to really become aware of what’s going on before you can do anything about it!

Q: What’s the most fun or fulfilling part of what you do?

The Diabetes Online Community (“DOC”) community is incredible and I’m thankful to be part of that community. They are so supportive of each other! I know if I ever needed anything, really needed help, there are so many people in that community who would be there for me in a flash.

On the other side, I get messages and comments from people every week thanking me for some of the work I do, because of how it’s impacted their lives with diabetes, how they think about diabetes. I’ve gotten messages from people saying my video blogs, as silly as they are sometimes, actually inspired them to start taking better care of their diabetes. Messages like that are gold to me.

You can follow Ginger on Facebook at:www.Facebook.com/Ginger.Vieiraand on Twitter atwww.Twitter.com/GingerVieira

You can still be part of the CURE

Yesterday the CURE banner was unfurled in the lobby of Miami’s Diabetes Research Institute (DRI). $63,000 was raised from people like you and me pledging as little as $10 and submitting their photo that’s now part of the banner. This includes a matching gift of $25,000 from campaign sponsors Animas and LifeScan. Monies raised goes to DRI’s singular mission – research for a cure.  

CEO Robert Pearlman said the banner stands as a visible testament to DRI’s mission, a reminder to all the scientists who go to their research laboratories every day how important their work truly is toward finding a cure.

Right now in fact, Scientific Director, Dr. Camillo Ricordi, has teamed with New Jersey’s Hackensack University Medical Center to test implanting insulin-producing islet cells inmonkeys’ abdomens rather than the liver. The hope is this will avoid the need for auto-immune suppression drugs. 

You can make a contribution to DRI either through info@drif.org or on the cure site, including raising your cure contribution to $50 to receive a mouse pad with the CURE image. 

How can you resist? After all I’m somewhere among those 1,300 photos – just on the right side of the ‘R’ 😉

The CURE banner will remain at BePartoftheCure.org.