Monthly Archives: November 2014

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

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.
 
 
 

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Things I love about the DOC.

On Monday, I spent a little time talking about what I’ve learned from the Diabetes Online Community. Today, I’d like to talk a little bit about what I love about the DOC. Think of it as my letter of thanks on the day before Thanksgiving here in the USA.
 

  • This is going to sound sappy (I really don’t care if it does), but I have never encountered so many helpful, supportive, and unpretentious people as I have in this community. That even includes church communities.
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  • It’s pretty safe to say that Wednesday nights are my favorite night of the week. If you don’t know what I’m talking about, join us on Twitter by following @DiabetesSocMed and the #DSMA hashtag beginning at 9:00 eastern time(US), and maybe Wednesday will become your favorite night of the week too.
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  • The way the DOC mobilizes and helps people is inspiring and heartwarming. See Spare a Rose, Save a Child, Strip Safely, and YouCanDoThis Project for starters.
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  • I love reading people’s stories. Whether someone is getting comfortable with an insulin pump for the first time, participating in a clinical trial, handling work and their diabetes or school and diabetes (or both), there’s nothing like watching those accomplishments through another’s eyes. You all suck me in and make me invest emotionally in your lives, and it’s the greatest show on earth.
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  • The global nature of the DOC is incredible. I’m not only talking about people living all over the globe, but also people living all kinds of different lives all over the globe. If you’re new to this community, I think you’ll be surprised by the fact that you’re very likely to find someone just like you. “Me too” is indeed powerful.

 
About four years ago, I was feeling about as low as you can imagine. Today, there is so much for me to find out about and celebrate. Given enough time, I suspect I could double or triple this list without too much trouble at all. There is so much joy and information and advocacy and encouragement out there. I am very thankful for the DOC and what it has meant to my life these past few years.

Help me add to this list: What do you really love about the Diabetes Online Community?
 
 
 

Some things I’ve learned from the DOC.

If you haven’t been by this place on the internet before, or if you aren’t up on diabetes talk in general, let me tell you that DOC stands for Diabetes Online Community. Loosely defined as places and people that those of us with whacked pancreases connect with in cyberspace.

There are lots of communities online, and like many others, ours is a place that teaches as well as supports and connects. Here are some of the things that either I didn’t know, or didn’t know very well before I discovered the DOC:
 

  • There are so many people who go through the same things I go through every day. Many of them handle managing their diabetes better than I do, and I’ve learned something from each of those people.
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  • Insulin on Board—I was mostly oblivious to insulin on board before reading blogs from people describing how they account for it in their diabetes management. I had heard of IOB; I just didn’t understand it at all.
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  • The art of the Pre-Bolus—I had never considered pre-bolusing ever, and had never had a doctor suggest it, before I read about it online. I wish I had the link to the first really great blog post I saw about it. I’m the kind of person that is helped a lot by pre-bolusing.
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  • Dual Wave, Square Wave, and Super Boluses—I had seen the options on my pump for square wave and dual wave boluses, but didn’t dare try them because I didn’t know if they would help me, or how they would help me. Reading how others have mastered these, plus the super bolus, has given me the confidence to try them from time to time myself.
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  • How to travel with diabetes—I’ve always thought I was an intelligent travel planner. In reality, I had just been going through the motions and been lucky. After reading/seeing/Tweeting with people in the DOC, I’m a much more savvy packer, and I’m able to get a lot of gear in a small space if I have to.

 
 
As always, nothing written here should be taken as medical advice. Still, there is so much we are still learning from each other. As our community grows, the chances to teach and to learn will grow. I really like that.

So let me ask you: What have you learned from the Diabetes Online Community?
 
 
 

A Thanksgiving diagnosis, and the Champion Athlete it produced.

It’s been a long time since we’ve told the story of one of our Champion Athletes With Diabetes. Let’s do something about that.

Cole is seventeen years old. He lives with his family outside of St. Paul, Minnesota, where he’s been a soccer nut since he was three days old, cheering on his sister in a big game. This is his senior year of high school, and he’s on the roster of one of the top teams in the state.

He’s a tough kid. Played through a thyroid problem a year ago, and two years ago suffered a broken tibia and fibula, which required two surgeries and extended time in a wheelchair. A year prior to that, Cole suffered a severe concussion, and in 2010 he was diagnosed with Grave’s disease.

Champion-Athletes-With-Diabetes-Medal

But the toughest blow came just before Thanksgiving five years ago. I’ll let his Mom, Kris, take it from here. This is from the e-mail she sent me:

“On that day he was anxious to go work out with his team. He had been working so hard he was losing weight ALOT of weight (that he didn’t have to lose), and those workouts had him needing to stay hydrated…or so he thought. I had called the doctor to make an appt. for after the holiday, but they insisted I bring Cole in immediately. Once there they efficiently ran a blood test before we even got in to see the doctor. While he was begging me to get him to practice on time, I heard the doctor outside the door telling the nurse to call Children’s hospital to let them know she was sending a new diabetic in immediately…. Our Type 1 journey had begun.

Thanksgiving morning Cole’s body was dealing with a drop from over 800 to 40 in a few hours. He was barely responsive and we of course were quite concerned. His father and I sat in the hospital family room eating leftover turkey wondering what was in store. Very late that night he started to be a bit more alert and he started mentally processing his diagnosis…the fears, the questions, the tears poured out.

The next morning he woke up early-, pale , so very thin and still sporting an IV, but with a very determined question for his nurse. “What do I have to do to get out of here? I have a game tonight? They explained that he had to learn how to keep himself safe, with meetings with the dietician, pharmacy, family counselor and diabetes educator, a process that takes two days. He told them he needed to eat and take a shower but that he would learn it all and they needed to release him in time to get to his game.

I’ve don’t think I’ve ever been so proud AND so scared as watching him play that game just hours after he got released. He did his first test on his own prior to that game on the side of the field. Afterward when we talked about the game he said he thought he did ok considering he saw three balls, but he figured he would just aim for the center one.

There have been many games since, with highs and lows and wins and losses. He has learned to read his body and adjust for his activity and all the effects of the other medical challenges and the way they have complicated his numbers. He has learned to advocate for himself with coaches, refs and others. He has stayed positive and focused on his training And he has achieved his goal of having others see him as a strong athlete and valuable member of the team. My hope is that this his senior year his team finishes strong and maybe goes to state….but regardless of their standing at the end of the season, I think Cole deserves an award for being an athlete with diabetes.”

How’s that for inspiring? Who can’t get excited about that kind of determination? Cole’s team finished with 13 wins and just one loss on the season, which included a win against the 2nd ranked team in the state. In his first-ever season as a defender, Cole made all-conference honorable mention. Take that, diabetes!
 
 
So… what about you? How great would it be for you to say you earned the same medal as Cole? I encourage you to nominate yourself or the special Athlete With Diabetes in your life today.

Four simple things will mint your medal, and only the first three count:

1. The athlete receiving the award must be living with diabetes.

2. The athletic event must have taken place in the last six months. For now, we’re going with a pretty loose interpretation of the word “event”. If you feel you’ve accomplished something important to you, that’s an event. ‘Nuf said.

3. Send me an e-mail at champswithdiabetes@gmail.com. Tell me your name, name of the athlete (it’s okay if it’s you), and your address (gotta know where to send the medal). Most important, tell me what athletic goal was accomplished, and when. Extra points if you tell me how you felt accomplishing the goal. Full disclosure: I reserve the right to use your testimonial here, on Twitter, and on Facebook. I will not use your name if you don’t want me to. As always, I will never share private information.

4. When you receive your medal, it would be great if you post a photo of it around the athlete’s neck. You can send a Tweet to @ChampsWithD (hashtag: #champdathletes) or post it on the Champion Athletes With Diabetes Facebook Page.

If it’s a big deal to you, it’s definitely a big deal to me too. I want to support you, or support the Athlete With Diabetes in your life. Send an e-mail for your award today.
 
 
 

Diabetes is hard. But we’re worth it.

Diabetes. Our lives with diabetes is a balancing act.

Keep those numbers in between 80 mg/dL and 120 mg/dL. We know that a hemoglobin A1c reading under 7.0% is optimal. As we also know, there are studies that show that people who achieve this are more likely to spend a fair amount of time with hypoglycemia (dangerously low blood sugar) than people who don’t. Among other things, hypoglycemia can potentially do damage to our hearts and our brains. Of course, if our A1c is over 7.0, we’re faced with a number that makes us feel like we’re not successful. It makes us want to do all that we can to get it under that number. Even though that could possibly mean additional risk of hypoglycemia. That’s a lot to consider.

But wait… there’s more. The closer our numbers are to perfect, the closer we are to bad lows. What do we do when those lows occur? We treat them, with juice or peanut butter sandwiches or cookies or Nutella or whatever works. Or all of those things, plus a couple more. Because above all, hypoglycemia is scary. It’s a near-death experience that shakes our confidence and makes us want to make it go away as quickly as possible. So sometimes we over-treat. Which leads us to hyperglycemia (high blood sugar) later on. And pretty soon our glucose management looks like this:

DSC00849

The hyperglycemia? In a word, that’s frustrating. Partly because we’re aware (we’re more than aware) of the complications it might bring years down the road, and partly because we don’t want our hard work go to waste just because we decided to eat something because it would save our life. Hyperglycemia makes us sluggish, tired, thirsty, and again, frustrated. And while we can encounter it after over-treating a low, we can also encounter it due to a bad injection site, bad insulin, or a crazy metabolism that can have us under 100 one day and over 300 the next. While the “eat 15 grams of carbohydrates, wait 15 minutes and check” idea is the standard for treating lows, it can take hours to come down from those highs. It may take the ingestion of copious amounts of water, lots of exercise, trimming our diet, extra insulin, or any and all combinations of the four to bring us back into range. Or back down into hypoglycemia again.

Add to that the fact that we’re more susceptible to infection, more likely to encounter eye and foot problems, under additional risk of heart trouble and stroke, and also facing people in our lives who just don’t understand why these things are true and want to blame us instead of helping us, and you can see why diabetes ain’t no kiddie game.

Yet we go on living our lives, in wondrous and amazing ways. We often have parents and spouses and girlfriends and boyfriends and just friends who help us and give us the strength to know that we’re worth all the trouble. If you’re not living with diabetes and you encounter someone who is, remember that diabetes is a moving target, it’s always, and it’s hard. The best thing you can do is live our lives alongside us, displaying the assets of perseverance and empathy that all people living with diabetes possess. Just ask us… we really are worth it.
 
 
 

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