Monthly Archives: September 2014

Talking with the FDA.

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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Last year, Strip Safely helped lead a campaign to get more people to comment on FDA draft guidance for glucose meters.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 That’s about six or seven times the number of comments they generally receive on draft guidance.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.

Decision 2014: What’s the Snap really like?


It’s been two weeks for me on the Snap insulin pump from Asante. I’m wearing the Snap as part of a free trial offered by Asante to all prospective customers. They’ll give you four weeks on the pump, supplies included, along with a voucher for the insulin cartridges you’ll need during your trial. So far, this is the only company I’ve considered that offered a free trial. Anyway, since it’s been a two weeks, I thought it might be time to give a little more insight. Hopefully, this won’t be too long… but since I’ve been able to check this one out more than any of the others, I probably have a little more to say about it. Here goes:

Set changes: When you’re working with the Snap, you’re working with pre-filled 300 unit insulin cartridges. The infusion set is self-priming too. You don’t have to worry about reservoir fill-ups or air bubbles, and that means you wind up wasting a lot less insulin just hooking yourself up again. Definitely a plus. As a result, you’ll probably spend more time on each cartridge. For that, Asante plans for you to use one specific set (with the primer(?) connector) for your changes including insulin. Then they want you to use a different set (without the connector) after 72 hours if your cartridge isn’t running out of life juice. I’m not sure how all that works, because personally, I’m not about to do a set change after three days, then another one 48 hours later. I just kept the first set in for the normal 5 days (5 ½?) it takes me to go through 300 units. And unless I’m dealing with some serious heat, that doesn’t seem to be too much of a problem. I will add, also, that the simple time savings of having a pre-filled cartridge isn’t that big a deal for me, though it is nice.

Humalog Only Accepted Here: Also, let’s not forget that the cartridges come in Humalog only. I’ve been primarily a Novolog user up to now. This is only my experience, so take it with a grain of salt: In my 2-plus weeks on the Snap, I’ve found that Humalog brings me down from spikey highs, but it does so in a very slow, stairstep kind of way compared to Novolog. As a result, I’m learning to avoid things like potato chips and pizza. I am getting better at managing my diabetes with Humalog, so this isn’t necessarily a deal breaker. Though that’s a good thing, it’s crazy to think I’ll never eat those foods again. If I had a choice between the two, I’d stick with Novolog for now.

Striker! You’re coming in too low! (Bonus points if you know which movie that’s from) One of the issues I found (that I don’t remember being covered in training, but I may have missed it) is that when your BG comes in under 70 mg/dL at the moment you’re sitting down for a meal, you can’t use the smart bolus feature. This happened a couple of times during my trial. My pre-meal check came in at 64 or 60, and I couldn’t enter those numbers using the smart bolus feature. To get around this, I wound up entering my BG number for the smart bolus at 70, then dialing down the insulin amount slightly to get to where I think I would be okay, as long as I ate right away. Also: When you do treat before eating, you do have the ability to enter in the carbs you already had (First Carbs), then the carbs you’re about to eat on a separate screen. It will figure out your bolus accordingly.

As a (somewhat) veteran insulin pumper, this feature drives me crazy. But if I was new to pumping, or a CDE or doctor working with someone new to pumping, I might find this a great safety feature. Again, this isn’t a deal breaker or a deal maker for me. It’s just a quirk of using the Snap, and I thought you should know about it.


I should also mention that the Snap will deliver boluses three different ways: The Now Bolus, Timed Bolus, and Combo Bolus. The Now Bolus is delivered right away. The Timed Bolus delivers your bolus at a specific amount of time (minimum 30 minutes). And the Combo Bolus is pretty much like the Dual Wave bolus on the Medtronic pumps… delivering a set amount now, and a set amount later, predetermined by the user (in 15 minute increments, which I like).

Beep volume: Love, love love the beep volume on this thing. I also love that it’s adjustable. This is such a simple feature. Why can’t other pumps incorporate this idea?

Additional features: The pump has a flashlight feature on it. That’s nice if you need a light and can’t find one anywhere else. Otherwise, turn the light on. If you’re low, your significant other will forgive you. Sorry… I don’t mean to make light of this feature… it shows that the manufacturer has added something that most People With Diabetes will find helpful.

The Snap also has the ability to create more than one basal profile. Again, I think all pumps should have this feature. When I do a long bike ride, I want to be able to change my basal profile for the entire day, not just perform a temp basal then forget about it once it’s complete.

Bolus delivery is pretty fast. Not sure how big a deal that may be for you (it is not a big deal to me), but I thought I would mention it. On the scale of bolus delivery speed, I’d put the Animas Ping at the top, then the Snap, then Medtronic, and t:slim far behind.


Finding your daily totals and how they translate into 5 day, 10, day, or 14 day averages (14 days is the highest setting) via the Log Book menu item is pretty easy. This is another feature that I don’t remember covering, but it was easy for me to find. Again, I think new pumpers (and their medical teams) may find this helpful.


Ease of use: The Snap is actually a pretty easy pump to use. Not a lot of clicks to get around to what you need. Menu descriptions make sense. If you like the pre-filled cartridge idea, and the self-priming, that’s an added bonus. I could imagine myself using this pump on a daily basis.

Here’s where I will also tell you that the local pump rep has been fantastic, answering questions and calling me a few days after I began to see if I had any follow-up questions or issues.

In a few days, I’ll be sending the pump back to Asante. Not because I’m not satisfied. Rather, because I want a little time to do some additional research and decide what is best for me from both a patient and an economic perspective.

I hope you’ve found this recap helpful. And if there’s anything else you’d like to know, be sure to ask.
Disclosure: I’ve been on a standard four week trial of the Asante Snap insulin pump. This is the same trial that is available to all users who are considering starting on insulin pump therapy, or are considering a pump change. I was not given anything by Asante, and I was not asked to write about my experiences. In fact, I did not tell them I’m a writer at all. All opinions, as always, are my own.

Hey! You look just like me!

A number of times, I’ve read blog posts from people who have seen someone wearing an insulin pump in public. In many of those instances, the writer can’t quite bring themselves to say something to the person wearing the pump. And I never understood why, until it happened to me too this past weekend.

I got up early Saturday morning to help my best friend get things set up for a flea market his group was sponsoring. It turned out they didn’t really need my help at all, so after 45 minutes or so I stated the obvious: “You don’t really need me now… I’m going to go home. I’ll call you later to see if you need me to help break things down when it’s over”.

I said my goodbyes, and as I walked out and toward my truck, I saw a guy, about my age, with exactly the same pump, in the same color, that I wear.

I stopped in my tracks as he walked by. I couldn’t believe it. I mean, yeah, nearly 30 million people in America live with diabetes. But I thought I was the only one in Baltimore. Okay, I knew I wasn’t the only one here, but sometimes it seems like it. Anyway, I thought hey, this is a perfect opportunity to meet someone else from the pancreatically-challenged part of the population. I should run and grab this guy by the arm and have a long conversation with him!

But before I could catch up with him, I noticed something else. He was enjoying himself. He was enjoying his day. I watched him from a distance, for about five minutes or so, and I realized this is the life that we had hoped for when insulin pumps were brought to market for the first time. Heck, this is what we want when artificial pancreas systems make their way to the market.

We just want to live our otherwise normal lives, in a normal fashion, just like people without diabetes do. Somehow, watching this fella enjoy the flea market, I was able to enjoy knowing he felt like the rest of the people around him.

In this case, I could really appreciate the fact that Diabetes Man, living his life, doing the same things as everyone else around him, was more important to me than getting to talk with someone locally who lives with diabetes 24/7 like I do.

It was a good indication that I need to remember to be grateful for the amazing advancements that have already made our lives better, even while we advocate for even better advancements for the future. As I headed home, my full heart and my big smile were indications that diabetes can and will be lived bigger and better every day by myself and Diabetes Man at the flea market. Nothing will stop us from enjoying life to its fullest.

What’s in your pigeonhole?

There’s always been a kind of up and down about my diabetes. Not just when it comes to blood glucose levels, but with everything. Work has been one of those things. Sorry that this is so long. Hope you’re still there at the end.

When I was first diagnosed, all the way through my first 15 years or so with diabetes, I didn’t really experience any clashes between my diabetes and my jobs. Later on, I had a few uncomfortable moments here and there, and for the last few years everything has been absolutely great. There are certainly reasons for all of this, and the reasons are probably not everything you would think of right away.

I should also mention that my A1cs were coming in pretty high during these years, when I was actually seeing doctors. I rarely tested my BGs. And I was on MDI (multiple daily injections); I didn’t start pumping until much later. So as long as I wasn’t running to the restroom every five seconds, there weren’t many outward signs of my diabetes at all.

Then I started the job I have today. That was around 16½ years ago. My A1cs were still in the 9s, but shortly after I started seeing a new endocrinologist who started me on Lantus. Now, my knowledge of diabetes was still practically nothing at this point, so I injected as prescribed, which was once per day. That’s it. The lantus did its thing, which was okay for a while. But my A1cs were still in the 8-9 range. And then, the lows started coming. Terrible lows. Lows that gave a new definition to hypoglycemia for me. Including a couple of bad ones at work.

After a couple of those events, I had to deal with internal conversations with my bosses. I have a hard time describing this, and after all this time I’m still not sure I can do a good job of it. I was called in, behind closed doors in one instance, and was asked “What are we going to do to make sure this doesn’t happen again?”. How do you answer that? Especially when your knowledge of your own diabetes is practically zero, but you think it’s not. Another conversation included a directive that because these lows seemed to be happening just prior to my normal lunchtime (not true, but they weren’t always aware of the other times), I was going to be required to go to lunch 45 minutes earlier than I had normally been going to lunch. Great… Let’s take the lunchtime issue out of the equation and add 45 minutes to the time I eat between lunch and dinner; I might go low right after work, but no one there will know about it because I won’t be there. Problem out of sight, out of mind. This was something no one else in my organization was required to do, and I was pretty unhappy about it, but what could I do? I had a really good job and people who depended on me. Plus, I was working with (and for) people who otherwise were very good, very nice people. I felt like I was running out of options, but didn’t know where to turn.

I muddled through a little longer. Okay, a few more years longer, before things began to change, and I think my co-workers started to see diabetes in a different way. Part of that involved a hypoglycemic event involving a co-worker who, until then, I was unaware had been living with diabetes. My boss came to me asking how I could help this person at that moment, while they were still trying to come out of it. I’m pretty sure they shouldn’t have shared the diabetes thing with me, but since they did, I shared what I felt during those times. I just started talking.

I told her about how hypoglycemia is a near-death experience, and how you can get this violent mental and physical swing between just wanting to survive, then feeling horrified that you’ve been such a bother to people who up to that point don’t know your diabetes and can’t hope to understand it on such a level, then wanting to prove how strong you are by going right back to work and performing like a superstar, all while feeling so physically weak that you just want to curl up in the corner and sleep for the rest of the day. This was the reward for coming back from the brink of extinction. And, oh, by the way, it might happen again tomorrow. You never know for sure.

I think that helped changed the perspective of how people at work viewed hypoglycemia, at least. My outward attitude started to change too. I started caring more about my personal survival and less about whether someone thought diabetes was a mark of personal weakness, or weirdness, for that matter.

Five years ago, I began to see a new endocrinologist, who for the first time, started to explain carb counts and blousing and updating basal rates based on exercise and eating habits. I started to check my BGs at regular intervals each day. I got off of the Lantus and started on Novolog. I started on an insulin pump, and my A1c started to come down.

Still, I felt pretty alone with my diabetes. Then my wife heard an interview on local public radio with someone who talked about an “artificial pancreas” and made me listen to it. I said, “Great, what do you want me to do about it?”. She said, “Find out about it. Someone online should be blogging about diabetes. Why don’t you do a Google search?”.

I did, and for the first time, I had that “Holy crap, I’m not alone… Holy crap, me too” moment. I began to learn even more, and talking to people living with and not living with diabetes. I remember having conversations with people at work and finding out that almost all of them were touched by chronic illnesses in one way or another. I had a conversation with one of my bosses where I was able to explain, and have understood, I think for the first time, that diabetes isn’t as easy as take a set amount of insulin, eat a set amount of food, exercise a set amount, and everything will be perfect. You can do everything the same every day for a month and have 30 different days’ worth of results. I learned how to say that from the diabetes online community.

I’m not sure what the moral of this story is. Sometimes I just need to write things to get them out of my head, you know? If there is a moral for me, it’s maybe that people act differently given different circumstances, and those circumstances are often influenced by things we’re unaware of at the time. I know I can’t influence every situation the way I want to. But I know that knowledge helps me deal with situations better, and I know that acting with empathy for all and perseverance through the difficult times can help me hold my head high even when the going is tough.

I read something recently about a workshop where a speaker was talking about acting with integrity in everything you do, and he mentioned that everyone gets pigeonholed at one point or another. His advice was, when you do, make sure your pigeonhole isn’t full of shit. The workshop was for new National Football League coaches and executives. Maybe the workshop should have been for existing coaches and executives. I don’t know. My question to you is:

What’s in your pigeonhole?

A few D and non-D thoughts.

Because this is my blog, here are a few random diabetes and non-diabetes ramblings, in no particular order:

– Ever notice a difference in how your diabetes works with different insulins? Don’t answer that. I don’t want to know… yet. The fact is, they all work. It makes sense if they don’t all work the same. The trick is in finding what works best for you, and then not using what you’re using as an excuse for results that don’t make you happy.

– Additional note: Don’t tell me they all work the same, then tell me I have to pay three fucking times more for one than I have to pay for another. There’s a point where copyrights of manufacturers and the rights of so-called insurers need to be tempered by the needs of patients who need said insulins to survive. Three fucking times more means the balance is skewed too far toward the manufacturer and/or the insurer, and not enough toward the patient.

– I’m very excited to be speaking later on today with the brother-sister team of Hayley and Ethan Maurice, who earlier this year climbed Mount Whitney, tallest peak in the contiguous United States, raising thousands for JDRF. I’m eager to find out how things have been going since their backpacking adventure, and get a little inside scoop on how things were during their climb too.

– Part of the reason why I’m speaking with the Maurices today, and not before their trip, is because my life has been scheduled beyond belief for the past several months. I mean, I’ve had something scheduled every single Saturday morning going back to mid-May. That’s the last time I’ve slept past 7 a.m. on any morning. Sorry to complain about it so much, but every time I whine about how busy I am, it kind of lets off a little of the pressure I’m feeling, plus it helps me to focus on what is really meaningful, which is the fact that I’m amazingly lucky to be so busy. And this Saturday morning: I’m helping a friend on the other side of town at 7 o’clock. Then I’m meeting a rep from a pump maker. See what I mean?

– I get the fact that people are feeling a little jealous about the ALS ice bucket challenge. I’ve seen enthusiastic ice bucket challenge videos from people who have never donated to any of the diabetes-related things I’ve advocated for. Hell yes, I’m jealous. But I don’t begrudge them one ounce of their fun nor one dollar of their fundraising. I don’t wish Lou Gehrig’s disease on anyone any more than I wish diabetes on anyone. They are both horrific things to have to live with, and the sooner they’re both eradicated from the earth the better. I’m sad that we in the diabetes world get a lot more attention for complaining about an article in the New York Times than we get for helping to save the lives of children who don’t have access to insulin or the means to pay for it. But as I’ve noted before… when I compete, I don’t feel good, even when I win. When I help, I feel good, even if no one notices. So let’s keep our eyes open for opportunities to help, and if we keep helping, I think an opportunity will present itself and grow like this one did for ALS. If: We are all working together. Supporting each other.

– Speaking of other things I (probably) have no business weighing in on: Is it okay now to call this whole Ray Rice thing a fiasco? Maureen probably had the best take on it yesterday when I asked her whether she thought the NFL had knowledge of the elevator video prior to yesterday. She said: “Sure they knew the video existed. They just didn’t want to pay for it like TMZ did. Good for the NFL for not paying for it; shame on the NFL for not doing the right thing in the first place, video or not.” My take: No one should get a free pass on this issue. Including the fans of my favorite football team. The statistics show that no one is untouched by abuse. I’d be really happy if we could say that no one is untouched by protection from abuse. No one. Ever.

Now I’m off to search for those Medicine X videos from last week. I’m jealous of everyone who was there, but in the most supportive of ways. I can’t wait to hear everything I’ve only heard up to now via Twitter and blog posts. Be safe, be well, and remember: I support you… no conditions.

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