Author Archives: StephenS

Hello… I’m Stephen. I live in Baltimore, Maryland, USA with The Great Spousal Unit, Maureen. I’ve been living with Type 1 Diabetes since January 1991. I’ve been a pump user since April 2010, and I’m currently wearing the Animas Vibe pump. Also wearing the Dexcom G5 continuous glucose monitor.

I found the Diabetes Online Community in the summer/fall of 2011, and that discovery has changed my life. I started this blog in April 2012, and since then, my diabetes advocacy has continued to grow. Among other achievements, I’ve attended and spoken up at FDA workshops and participated in clinical trials.

I’ve been thrilled to serve as a facilitator for the Diabetes UnConference. And I’ve been honored to volunteer for Diabetes Patient Advocacy Coalition. You should Google both of those.

I’m currently serving as a member of the State of Maryland’s Advisory Council on Health and Wellness, where I am co-chair of the Diabetes committee. In addition, I’m part of the 2018 Reader Panel at Diabetes Forecast magazine.

I’m always searching for the perfect balance between the highs and lows of my blood glucose level and my life… always searching for the Happy Medium.

Anything you’d like to share? Please let me know… I’d love to hear from you.

Interview: Kevin Sayer, Dexcom President and CEO.

September 23, 2015 – 10:10 am

I had a super conversation this week with Kevin Sayer, President and Chief Executive Officer of Dexcom, the most popular continuous glucose monitor on the planet.

This was intended to be a podcast interview, but due to technical issues on my part, we were not able to record our conversation. Too bad, because it really was a good one.

Since I’m not very good at writing down things word for word (one of the many reasons I started a podcast), I will instead give you a synopsis of the questions I asked (in bold), and the answers that were given. Just imagine us talking, and it will be almost like being there.
 
 
First, I asked Kevin about his twenty-plus years of experience in the medical technology and medical device field. What has that experience taught him about the importance of what he does, and how it affects patients living with diabetes?

He answered this by telling me about a Facebook post he read earlier in the day. It was from a parent of a child with diabetes, who was in the hospital. The child was wearing a Dexcom CGM, and had a glucose check performed by a nurse. The check came in in the 240 mg/dL range, and about an hour later, the nurse came back to perform a correction bolus based on that amount. Only the Dexcom the child was wearing had shown that his BGs were coming down, and were still trending that way. After some pleading, the parents were able to convince the nurse to check again before blousing. That check resulted in a reading in the 60s. In this instance, the Dexcom, and the parent’s trust in what they were reading, helped to avoid an emergency, and possibly saved a child’s life. Cases like that help underscore what Mr. Sayer, and Dexcom, are trying to accomplish.

Dexcom has been pretty innovative over the years. In the past year, we’ve seen the rollout of Dexcom Share, and FDA approval of the Dexcom G5. A little over a week ago, they received the CE mark of approval in Europe for the G5, so they’ll be rolling out that product to Europe in the coming weeks. Has Dexcom started shipping the G5 to users in the USA?

The answer is: Yes! Just this week, the G5 started going out to users here in the USA.

FYI: If you are currently on the G4 Platinum product, there are low cost, and in limited cases, no cost upgrades so people can more easily move to the latest and greatest Dexcom system. Go to the Dexcom website for more details.

In the news release on the G5 in Europe, I noticed language that states:

“…the new Dexcom G5 Mobile CGM system does not require confirmatory finger sticks when making treatment decisions.”

Now, we know that’s a no-no here in the USA, and the G5 has not been approved for that here. But I also know there are clinical trials ongoing to help determine the efficacy, I guess, of People With Diabetes dosing insulin based on CGM numbers rather than fingersticks. Other than being the CGM involved in the studies, is Dexcom involved in those trials in any other way?

This elicited a passionate response I wasn’t expecting. Kevin Sayer is firmly behind the idea of using a properly-functioning, properly-calibrated CGM to inform insulin dosing decisions, independent of fingerstick confirmation. Dexcom has mounds of data, from multiple studies, and they are planning to go to FDA at some point to get the, I believe the term was, adjunctive exemption that would allow Dexcom to promote their CGM (either the G5 or a future generation product) in the same way that they are promoting it in Europe. He believes that trending data gathered over hours, rather than a one-time BG meter reading, is a more accurate way to determine insulin dosing decisions.

I’m really blown away by the amount of collaboration that Dexcom has been involved in over the years, and I’m talking several years, at least back to 2007. Most recently, we’ve seen Dexcom become part of the Animas Vibe system, and part of the T:Slim G5 system. In an industry that gets a lot of criticism for not playing well with others, what’s the secret to Dexcom’s success in making these partnerships happen time after time?

Mr. Sayer gave kind of a two part answer to this. In the beginning, Dexcom was very small, and collaborating with a bigger partner was a way to grow the business and forge relationships. Today, it’s about Dexcom being the CGM of choice, and making sure that if a Person With Diabetes wants to use a Dexcom as part of their overall diabetes management, they should be able to do that. And forming relationships years ago helped Dexcom have those conversations with other companies when the time came to branch out.

I also asked: Does he see Dexcom as a leader in collaboration as well as technology? The answer is yes. It happened the way it happened over the years, but yes, Dexcom sees collaboration as essential and good for Dexcom.

Finally, I asked about CGM coverage for Medicare patients here in the USA… rather than talk about what passage of such legislation would mean to his company, I wanted to ask: How does it make you feel knowing that patients on Medicare, some of whom were your customers a year or two ago, are unable to use CGM technology at all, without paying 100 percent out of pocket for it?

This, he admitted, is the biggest thorn in his side right now. It’s the biggest complaint that Dexcom gets on a regular basis. He mentioned that his most reliable customers, in addition to children using the G4 and G5, are those in their 40s, 50s, and 60s, who might be less hypo aware, and rely on the safety of CGM technology to help keep them out of the hospital. And have been steady CGM users for a long time. To take all that away just because you reach a certain age doesn’t make sense. Dexcom is working alongside others to try to convince lawmakers to add a category to Medicare coverage, allowing seniors in my country to continue using CGMs. The patient data and the dollar data backs it up. Dexcom will continue to fight for CGM coverage for patients on Medicare.
 
 
You know, the thing about Dexcom is, you can’t even blink hardly without seeing another announcement about a new product, upgraded technology, regulatory approvals, and continued partnerships. It has to have been an exciting almost nine months as CEO for Kevin Sayer. From my standpoint, I’m looking forward to what the next nine months and beyond will bring from Dexcom.
 

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What does that mean, anyway?

September 17, 2015 – 9:05 am

After my interview with Rick Phillips for TuDiabetes Tuesday, I took some time to reflect on what we discussed. There were a lot of acronyms in there: CGM, DSMA, and a couple of others I can’t remember right now.

You can probably relate to this when I tell you: Before I found the Diabetes Online Community, I had absolutely no idea what those things meant. Or even that they existed.

Those of us that have been communicating about diabetes for some time, even people like me with just a high school education and a few years’ experience writing about diabetes, tend to shorten our words an awful lot sometimes. On one hand, that’s just the nature of communication these days. Why write out “been there, done that” on your phone when you can just tap out “BTDT”?

On the other: If you’re new, and all this is new to you, it can be a bit overwhelming at first. I wonder sometimes if we lose people with our thorough knowledge and discussion of the A1cs and BGs. I don’t think so, at least not all the time. But sometimes I worry that while I’m trying to make a point about IOB, or CDEs very quickly, I make it so quick that it’s easy to lose someone on the outside of the conversation, knowledge-wise. I don’t ever want to do that.

So if you ever see something I write, or hear something I say, and it doesn’t make sense to you, I hope you’ll ask me for an explanation. You deserve that.

And if you don’t want to ask me for an explanation, guess what? TuDiabetes is an amazing source of information. They even have this Diabetes Terminology Glossary that explains just about everything you’ll ever want to know about the acronyms that power our diabetes discussions.

I admit it: I’m a diabetes acronym-dropper. But don’t let it rattle you. And in the words of Bennet Dunlap, LYMI.
 
 
CGM: Continuous Glucose Monitor

DSMA: Diabetes Social Media Advocay (the #DSMA Twitter chat is every Wednesday at 9:00 ET)

DOC: Diabetes Online Community

A1c: According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), “The A1C test is sometimes called the hemoglobin A1c, HbA1c, or glycohemoglobin test. The A1C test is the primary test used for diabetes management and diabetes research.”

BG: Blood Glucose

IOB: Insulin On Board (the insulin still active in the body at any given time)

CDE: Certified Diabetes Educator

LYMI: Love Ya, Mean It.
 

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New and old videos.

September 11, 2015 – 9:05 am

I’m talking old and new videos on this Friday… let’s start with the new:

New Videos
First, new videos. So new, in fact, that they haven’t been made yet. But a video will be made on Tuesday, September 15 at 4:00 Eastern time here in the USA. That’s when I’ll be talking to Rick Phillips of TuDiabetes. We’ll spend the better part of an hour talking diabetes, blogging, and whatever else Rick wants to talk about. I hope you’ll join us. CLICK HERE to find out more. When the time comes, CLICK HERE to follow along and join the conversation.

I’m really looking forward to this.
 
 
Now… old videos:

Old Videos
Back in April, I was lucky enough to attend something called the HealtheVoices Conference. It was a terrific weekend where I met many other people living with chronic conditions like mine. The interactions, the connections made that weekend are having a lasting effect on me (Diabetes By The Numbers), and this week, I was reminded of them again when these videos were released. I wrote about the weekend here. At the end of the conference, we sat down with an interviewer and answered three questions. The answer to those three questions, from many different points of view, is below.

Note: Janssen Pharmaceuticals paid for my travel, hotel, and meals so I could attend the HealtheVoices Conference. All opinions, as usual, are my own.

Why should you view these videos? Because you’ll see and hear people living with chronic conditions, many of whom are not living with diabetes, who are just as passionate about what they advocate for as I am about advocating for better access to care, treatment, and medication for People living With Diabetes. They are also reaching out and building communities and inspiring others, and I thought you might like to see who some of them are.

And hey… there are some DOC people in there too. In the first two videos, you’ll see the always compelling Christel Marchand Aprigliano. The last video starts with me, and also includes Karen Graffeo and Kerri Sparling, who always sound waaaaay better than I do.

When I saw my part, and saw that I was tagged as a Type 2 Diabetes advocate, I paused for a moment…

Then I realized, yeah, I live with Type 1, but I’m an advocate for all People With Diabetes, so if you want to label me as a Type 2 advocate, then okay… because I’m that too.

 

I hope your Friday is a good one, and I hope your weekend is full of fun and excitement. And good glucose. Remember:

I support you… no conditions.
 

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Public Workshop Alert.

September 9, 2015 – 8:59 am

After writing here for 3½ years, I can tell you that there is no shortage of people who like to add their two cents on a subject. Whether it’s insulin costs or the importance of Medicare coverage for CGM users, the Diabetes Online Community knows how to speak up when asked.

Here’s something you may not have heard of yet, and it’s tailor-made for you to learn something and speak up too.

On September 29 and 30, the U.S. Food and Drug Administration is hosting a public workshop. The workshop is geared toward the discussion of patient labeling on medical devices, like insulin pumps and continuous glucose monitors (and maybe artificial pancreas systems?). To be fair, it is not specifically diabetes related, but discussions at this event could certainly have implications for People With Diabetes.
FDA
The workshop will be held at FDA’s sprawling White Oak campus in Silver Spring, Maryland, outside of our nation’s capital. The two day agenda includes presentations from FDA staff and others, and will cover things like FDA’s development and review process, new approaches to patient labeling that aren’t necessarily paper-based, user assistance information, and more. I really like the way day two begins, with a session on Identifying the Gaps in patient labeling, followed by a session on Closing the Gaps in patient labeling.

If you live in or near Washington, D.C., this is an awesome opportunity to not only find out more about patient labeling of our devices, but actually join in the discussion too. Let me give you the link so you can find out more:
CLICK HERE to find out more and register for this public workshop
 
 
Also: Although there are no details yet, FDA says that there will be a webcast of this workshop.
 
 
So… for everyone who says, “What can I do?”, my answer is this. You can do this. You can listen in, or attend, in person, this public workshop. You can take notes. You can form your own opinion. If you are there in person, you can speak on behalf of all of us who are living with or affected by diabetes. When it’s over, you can tell everyone you know about what happened and what was discussed.

And I will be thankful you were there for me.
 

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What has to happen?

September 4, 2015 – 9:18 am

I’ve wanted to ask this question, and know the answer to it, for a long time, even before I started blogging:

Why does the cost of insulin continue to skyrocket?

What I’ve found out so far is very little. At least very little that allows me to point my finger in a definite direction and say “this is why”. It’s complicated, and if I were to begin to point a finger in a particular direction, that’s where I would start. We can’t find the forest of cash for the trees.

The information on drug research, side effects, production costs, costs to file with regulatory authorities like the U.S. Food and Drug Administration, efforts to build marketing campaigns and pay sales reps to visit endocrinology practices is…. Non-existent. Nobody knows how much it costs to bring a new insulin onto the market (and keep it selling), and depending on how each phase of research, development, and rollout goes, the costs might vary.

Let’s not forget about the rest of the overhead. In Novo Nordisk’s latest financial results, 11.2 percent of their 4 billion dollars in revenue from January through June went to administrative costs, which includes things like pay and benefits, but not only pay and benefits. That’s 448 million dollars.

That seems excessive. And maybe it is. Maybe it’s not. The point is, we don’t know what’s excessive and what’s not in a financial statement for a company that grossed 4 billion dollars in the first six months of the year and published all of its financial line items in a one page document.

Eli Lilly did a much better job, I thought, of detailing their latest quarterly financial statement, but then again, they’re on the other end of the spectrum, and I had to search a little to find Humalog sales listed in the 28 page statement. In case you’re wondering, it was $1.3 billion year-to-date. For a drug that’s nearly 20 years old. Even if it cost a billion dollars or more to develop and produce these drugs, they have certainly more than paid for themselves by now.

But let me back off here. Maybe I shouldn’t point at Lilly and Novo. It’s not just about how much money is being made.

Actually, it’s about the right of a patient to get medication they need to survive, at a price that won’t have to make them have to choose between staying healthy and putting food on the table. Make no mistake: As insulin gets more expensive, this type of decision is already being forced upon a growing number of People With Diabetes here in the USA.

How companies (by companies, I mean drug makers, insurance, hospitals, etc.) reach the point where they charge as much as they do, and we get closer to the breaking point budget-wise, is a matter of great confusion. I really don’t know if this is by design, or if I just don’t have a good handle on the numbers. Here’s what I know:

Insulin should be more affordable.

When I’m tasked with solving a problem like this, I often think back to when The Great Spousal Unit and I bought our house. We knew we were ready to buy, but we didn’t even know if we could even get a mortgage, let alone whether we could afford one. So my solution was to find out what needed to be done to buy a home, and complete each step along the way, until we either moved into our house or knew where we didn’t qualify.

So in this case, I begin with the overarching statement: Insulin should be more affordable. Now the idea is, what needs to be done to make insulin more affordable? What are the steps? Can they all be accomplished? If they can’t all be done, what can’t be done? Why? How do we break down the barriers? What would have to happen to make insulin more affordable?

Why is a drug discovered nearly a century ago more expensive than ever?

Why is a drug approved in 1996 more expensive today than it was when it was approved?

I don’t know if I will get anywhere. But I really want to have a better working knowledge on this subject. I don’t know how long it will take, but I’m going to try to find out as much as I can.

In the meantime, feel free to give me your knowledge, if any, on why the cost of insulin is getting farther and farther out of reach. I’ll let you know if I find out anything.
 
 
There are programs dedicated to helping those who have difficulty meeting the cost of insulin and other diabetes drugs and supplies. Including programs run by Novo Nordisk and Eli Lilly & Co. Rather than re-inventing the wheel, I’ll refer you to this helpful post on the subject from Christel at The Perfect D:
Need Help with U.S. Diabetes Supplies and Medications?
 

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