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type2diabetestreatments-blog · 8 years ago

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The Artificial Pancreas: Now and in the Future

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The Artificial Pancreas: Now and in the Future

For years, an artificial pancreas was a pipe dream. Now, we’re closer than ever to systems that will automatically adjust background insulin. Here’s what’s in the works��and what’s still to come.

By Andrew Curry May 2017

Since she was diagnosed with type 1 diabetes almost 40 years ago, Alecia Wesner has spent a lifetime managing her condition: Crunching numbers, counting carbs, and trying on a variety of wearable devices to help keep her blood glucose under control. “My numbers are within a recommended target, but I work like crazy at that,” she says.

So when Wesner, 43, was asked to participate in trials for Medtronic’s hybrid artificial pancreas insulin delivery system, the New York City–based lighting and jewelry designer jumped at the chance. The system is an automated blood glucose management tool—what some researchers are referring to as a closed-loop system or bionic pancreas.

Over the course of a few years, Wesner has spent weeks going to study visits at Mount Sinai Hospital in New York City and sleeping in hotels while hooked up to an artificial pancreas prototype with teams of doctors watching her blood glucose levels rise and fall in real time. She has since used the systems—made up of an insulin pump, a continuous glucose monitor (CGM), and a smartphone application running a program that lets the two communicate and administer insulin—while training for cycling events.

Designed to mimic the function of its namesake organ, the system calculates a person’s insulin needs based on glucose readings, activity, carb intake, sleep, and other factors. Then it automatically adjusts and delivers basal doses of rapid-acting insulin around the clock. That’s an especially big deal at night, when people with diabetes have to wake up in order to treat highs or lows.

Where the artificial pancreas most noticeably differs from the real thing is in mealtime insulin delivery. In the trial Wesner took part in, the experimental system calculated mealtime boluses based in part on her current and trending insulin and glucose levels, but she had to count carbs and deliver the bolus dose by pushing buttons, just like using a regular insulin pump.

Wesner says the systems have gotten smaller, more streamlined, and more reliable since she started participating in the trials. They’re essentially modified existing pumps and CGMs, worn on a belt or in a pocket, that interact with a person’s body via an infusion set and a sensor inserted under the skin. For someone who’s lived with diabetes almost her entire life, the promise of a device that could reduce some of the daily burden of the disease is tremendous. “It’s one thing to hear about technology that could change your life,” she says. “It’s pretty different to actually wear it.”

Many people with type 1 and type 2 diabetes could have access to more than a prototype soon. In September 2016, the Food and Drug Administration (FDA) approved the first partial artificial pancreas system—Medtronic’s MiniMed 670G—for sale in the United States. As of press time, it’s expected to release in late spring. At least five other companies are working on their own systems, hoping to bring them to market by 2020.

The first devices to hit the market will be so-called “partial” artificial pancreases, requiring user input and monitoring for mealtime boluses and automatically adjusting only basal insulin. A few years from now, developers hope to release systems that will manage all insulin delivery automatically: The user can essentially strap it on and then forget about it.

Doing the Math

When it’s working properly, the pancreas is a wonder of balance and sensitivity. Inside the hot dog–sized organ, millions of beta cells monitor the levels of glucose in the bloodstream. When glucose climbs too high, the beta cells release insulin, a hormone that prompts cells elsewhere in the body to absorb and store the glucose and shuts off the release of glucose by the liver. If blood glucose goes too low, a different set of cells in the pancreas—called alpha cells—pump out the hormone glucagon, which tells the liver to release stored glucose.

Diabetes is what happens when the beta cells in the pancreas stop working as they should. Without the beta cells to sense rising (or falling) blood glucose levels and to release insulin accordingly, people with diabetes are forced to rely on substitutes—from finger sticks and insulin pens to CGMs and insulin pumps. These require users—typically people with type 1—to master sometimes-tricky tools and techniques and carry around one or more devices all the time.

And then there’s the math. The latest generation of CGMs may provide accurate, real-time readouts of glucose levels. But it’s still up to users to program basal rates, count carbs, and reactively decide to deal with highs and lows—instead of avoid them in the first place.

“The burden of diabetes self-care with technology has become more challenging,” says Carol Levy, MD, an endocrinologist at Mount Sinai Hospital in New York City who heads the Icahn School of Medicine’s Artificial Pancreas Research Program. “You have all this data, and the patient has to figure out what to do with it on a day-to-day basis.”

Relieving the Burden

The flood of numbers may help explain some curious patterns researchers have noticed when it comes to who uses technologies such as CGMs and pumps, the building blocks of artificial pancreas systems. In a study published last year in Diabetes Care, researchers found that nearly half of all people with type 1 diabetes in a group of about 15,000 were reluctant to use devices because they were a “hassle.” Interestingly, the study showed that older users were more comfortable with using technology to manage their diabetes, while younger people—those between 18 and 25—were the least likely to wear CGMs or insulin pumps.

The artificial pancreas products should make things easier. In theory, the idea is simple: Combine a continuous glucose monitor with an insulin pump. When the CGM senses glucose levels rising, it sends a signal to the insulin pump to dose insulin. When it senses dropping glucose levels, it decreases or suspends insulin delivery.

At the system’s heart is a complex formula, called an algorithm, built into the device or stored on a smartphone in the form of an app. “It’s a very sophisticated computer program,” Levy explains. The algorithms take in data—how long insulin lasts, how fast glucose is rising, how a person reacts to insulin—and calculates how much insulin or, in some models, glucagon to deliver.

The first devices to market won’t do this all by themselves. In its press release heralding the Food and Drug Administration approval of the first hybrid closed-loop insulin delivery system, the type 1 research advocacy group JDRF dubbed the system an “artificial pancreas.” The term has been eagerly adopted as shorthand for a variety of systems going through testing for safety and efficacy right now.

But Medtronic’s system, along with Insulet’s Omnipod Horizon, are what Levy calls hybrids: They still ask users for carb gram input before meals to calculate how big of a bolus to deliver, for example. Which means carb counting won’t be a thing of the past for a few more years, at least.

That’s part of the reason not everyone likes the term “artificial pancreas.” Boston University biomedical engineer Ed Damiano, PhD, calls his iLet prototype a “bionic pancreas”—reflecting, he says, its fully-automated nature.

Stanford pediatrician Bruce Buckingham, MD, on the other hand, is sticking with “closed-loop system.” He argues that “artificial pancreas” implies something much closer to a replacement organ than the reality, which is a wearable device and sensor plus an infusion set, all of which have to be changed regularly.

And Bigfoot Biomedical, a California-based company founded by four fathers of kids with type 1 diabetes, prefers the term “automated insulin delivery.” “Our system does require user input,” says Bigfoot spokesperson Melissa Lee.

The systems may represent an additional cost for consumers, although manufacturers aren’t sure how much more. Insurance coverage is also an open question until more devices are on the market. “Are insurance companies going to pay for these? We don’t know the answer yet,” Levy says. She argues that the improved blood glucose control the devices provide saves money in the long term by heading off complications.

Doctors say it’s at night when these early systems really shine. While nighttime insulin requirements tend to be more predictable because people don’t eat—and the body is at rest—during sleep, the threat of low blood glucose at night is something that people with diabetes dread. “I spend a lot of time having things beep at night, either because I’m high or low,” says Wesner of her current continuous glucose monitor. She then has to decide whether it’s a false alarm or necessary to treat with insulin or fast-acting carbohydrate. “The thought of having something that would manage that is really appealing.”

The first generation of artificial pancreas devices—such as Medtronic’s 670G—will go a long way toward helping people with diabetes sleep better. The JDRF, which has been lobbying for fast-tracked approval for the systems for years, sees the arrival of the devices as a major win. “People who have participated in artificial pancreas clinical trials have not only attained better overall glucose control but have experienced the relief of sleeping through the night and waking up in the morning with blood glucose levels within target range,” Aaron Kowalski, PhD, JDRF’s chief mission officer, told Diabetes Forecast. “That’s an improvement in quality of life.”

In tests, people with type 1 diabetes using artificial pancreas devices stayed within their desired blood glucose range much more often overall than people who weren’t using the systems. Pilot studies in people with type 2 who depend on insulin show that artificial pancreas devices kept their blood glucose levels within recommended ranges as well.

“This is a major historical milestone,” says Buckingham, who has worked with children as young as 7 to test the Medtronic device and several others. “It gives people more security and will make them sleep a lot easier. Waking up in the 100 to 140 mg/dl range is a pretty good way to start the day.”

So what’s taken so long?

Smartphones and Sensors

Developing safe, reliable algorithms is a huge challenge. It’s also important to remember that a mistake or glitch in the software can have serious or even deadly consequences: Too much insulin can drive blood glucose levels dangerously low, resulting in hypoglycemia, coma, or death.

That’s why developing a system that reliably and safely mimics the body’s own insulin delivery system is fiendishly complicated. Ed Damiano, PhD, should know: He’s been trying to develop one for 17 years, ever since his then11-month-old son, David, was diagnosed with type 1 diabetes.

Almost immediately after his son’s diagnosis, Damiano—now a professor of biomedical engineering at Boston University—dedicated himself to solving the problem. The goal was obvious: an insulin delivery system that could monitor and adjust his son’s glucose levels automatically as they both slept.

How to get there wasn’t as clear. Damiano began by developing algorithms to manage the balance between insulin, glucagon, and blood glucose. It was a tremendously optimistic project to undertake. At the time, there wasn’t an accurate or reliable CGM on the market. Until recently, the glucose readings from most commercially available CGMs could be thrown off by something as simple as Tylenol. That’s not a huge problem when backed up by regular finger sticks, but it’s a major barrier to a true artificial pancreas system that would run without user input.

When Damiano started, a desktop computer was needed to run the programs, which he tested on pigs in a lab. The first tests in people were conducted in hospitals because participants had to be connected to bulky computers.

Fifteen years later, that’s all changed. “The artificial pancreas was really waiting on the mobile phone industry, as well as the sensor,” Damiano says. “Now we have smartphone technology with an app ecosystem that made it possible to just drop these programs on your phone.”

Damiano says he’s on schedule to get FDA approval for his iLet device in early 2019, in time for his son’s sophomore year of college. The system would manage basal insulin like other artificial pancreas devices, but with an added bonus: It won’t require manual bolus doses, instead sensing the post-meal rise in blood glucose and adjusting insulin accordingly.

There’s much work to be done, of course. “It’s still an inelegant system,” Damiano says. “It’s a device you carry with you 24-7. It’s plagued by needing battery power, needing to change infusion sets, cartridges, and sensors. But it’s the best solution we have today. Ultimately, there will be a biological cure for diabetes, and this device will be the bridge to that cure.”

Nuts and Bolts

The artificial pancreas is groundbreaking, but it’s still at the gawky adolescent stage: It depends on current insulin formulations and pump delivery methods. With that in mind, smart people and companies around the globe are focusing on these two areas ripe for advancement.

Better insulin infusion. Artificial pancreas systems rely on infusion sets to ferry insulin into the body, but those come with their own challenges: variations in absorption at different skin sites, tissue damage from poor site rotation, kinks in cannulas, and adhesive failure. Proper insertion technique and site management are crucial—but are subject to human error. And until longer-wear products are a reality, users still need to change their set every few days.

Faster insulin. The rapid-acting liquid insulin analogs currently on the market are speedy. But especially with the absorption issues mentioned above, they can’t quite compete with first- and second-phase insulin release by a healthy pancreas in response to eating.

Different Technologies

Here are some of the different systems researchers hope to roll out in the next few years:

Hybrid Closed-Loop: This setup fully automates basal insulin doses but still requires carb counting and input from users to confirm correction insulin doses and mealtime boluses. Because such systems are the least ambitious, they’re the first to make it through the Food and Drug Administration’s clearance process. The first device in this category to hit the market is Medtronic’s MiniMed 670G. Also in development: Insulet’s tubeless Omnipod Horizon Automated Glucose Control System, Bigfoot Biomedical’s Bigfoot Smartloop, and Tandem Diabetes Care’s inControl.

Closed-Loop: When they’re commercially available, possibly in early 2019, the algorithms in these devices will be able to sense and bolus for mealtime blood glucose surges and other irregularities by themselves. The Beta Bionics iLet is an example of a closed-loop system.

Dual-Hormone Systems: Damiano and others are working on artificial pancreas systems that can administer both insulin and glucagon, the hormone that tells the liver to release stored glucose into the bloodstream to replenish low blood glucose levels. Ideally, such devices will be able to prevent both blood glucose highs and lows, further reducing the burden of care for people with diabetes. But these are still several years from commercial approval. “A bi-hormonal system is more complicated to develop,” Damiano says, “but it provides a simpler end technology to the user.” One hurdle: There’s no commercially available or FDA-approved stable liquid glucagon—yet.

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insulingetsmelow · 8 years ago

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Hey what's your opinion of Medtronic pumps? I'm getting the new one they're coming out with in Canada in about a month and I've noticed a few people saying bad things about Medtronic

Hhahaa, ummm, I’m going to preface this with I have not worn a Medtronic pump in about 6 years I think? Maybe longer than that. So take my opinion with a grain of salt, it’s so outdated.

Anyway, old-school Medtronic pumps were very user friendly from a GUI stand point. Menus were very simplified and I don’t remember menus inside menus inside menus.

The main issues that I had with MiniMed pumps were technical issues and customer support. Since MiniMed is not a tube free system or enclosed system like Omnipod, plastic tubing can come loose out of where ever you tucked it and get caught on things. Door knobs and other people mostly could cause the tubing to get caught and rip the site out. In certain conditions, such as water slides at water parks, the tubing can actually melt. The old-school pumps were also not water-proof (despite being marketed as such), I have no idea if that has changed or not. The old-school pumps would also short out if you are like me and don’t like having the pump clipped to your belt and preferred it on your pants pocket. If you’re a person that enjoys wearing dresses and do not have the boobage to hide the pump between the tatas then you may have to invest in a garter belt for holding the pump.

Moving on to the second bit. Their customer service was absolutely garbij to work with. They would constantly flip between saying that insurance covered supplies and did not cover supplies. So we would have to pay upwards of $3,000 USD every time there was a miscommunication between the insurance and MiniMed.

To leave off on a more positive note, like I said, my information is very out of date. I’m sure MiniMed has gotten their shit together since then, or else they wouldn’t exist. CGMs for the MiniMed pumps are also part of the pump itself, so in terms of insurance, it’s technically all one device (I don’t know if Canadian insurance would cover multiple devices or not, I only know that American insurance does not)I hope I’m not overstepping, but I’m going to extend the question to any of my followers that are either currently using a Medtronic pump or have used one more recently than over half a decade ago. If any of you guys have anything else you think would be beneficial to this anon, feel free to add a comment!

#actuallydiabetic #diabetes #anonymous #shutupphone #phonereplies #asks

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sjostke · 8 years ago

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Hiking Boundary Peak, Nevada. 4007 meter

Don’t be afraid. Just prepare yourself and try it.

Why Hiking Boundary Peak ?

In 2012 I made it to the summit of Boundary Peak. The highest peak in Nevada. But it wasn’t my intention to hike this peak. Why did I do it ? August 2012, just a few months after my divorce, I wanted to have som time for myself. It was the first time I went to a holiday without my childeren. My goal was to enjoy the whole holiday and hike Mount Charleston near Las Vegas, Nevada. I practice a lot. Hiking with a backpack with extra weight in it and with my hiking boots. But Boundary peak is almost 5 hours drive from Las Vegas, so who go there ?

I am a Hertz Gold member and I got some kind of SUV car which was very suitable for off road driving. So I was looking to have a nice off road trip and I went to Boundary Peak base. And while I was there I thought, well, I prepared myself to hike a mountain. Why not try the highest peak of Nevada ? I arrived in the evening and slept in my car. There we some others and it was nice at the bbq.

The Hike to the trail

In the morning we would get up at 5:00 and start walking at about 5:30 am. It took an hour walking before we were at the beginning of the trail ! if you have a four wheel drive you could drive, but we like the extra walk. 😉

What I learned several years ago from an elderly man, is that you hike your own pace and take it slow. As long as you can reach the summit, it doesn’t matter if it is a good time or not. You made it, that counts ! The begin of the trial is kinda flat, so it’s easy to walk and have a 5 minute break at least every hour.

Here we go.

Road to the Boiundary Peak summit.

We started with a group with 8 persons. The first hours were not that hard. Just a walk in the meadows. And then I saw the summit for the first time. It was impressive. Before the really nice climb, two persons stay behind. Slowly we walked to the summit. There was a lot of loose rocks and stones which made hiking difficult. There was a part were we had to scramble on top of loose rocks. Pretty Cool

Now it was time to walk your own pace. Sometimes I stopped often and sometimes I could walk a lot. Depending on my legs and oxygen in my lungs.

Yeah ! The summit.

At about 1:00pm we reached the summit and had a nice rest there. It is possible to reach another summit which was in California, but we passed. We were glad we made it to 4007 meter!

During the walk down I had a little bit of headache. The beginning of altitude sickness. Because we walked down, it was just a half hour I had some kind of headache.

Back at the grassland we saw some wild horses. Very nice to see those elegant animals in the wild.

At about 06:30pm I reached my car and said goodbye to the nice “strangers” which made it possible that I made it to the summit ! The walk up was hard and so is the walk down ! Don’t underestimate this.

What about my diabetes ?

Enough food and water are essential. For a “healthy” person and certainly for me. Drink a lot water (Almost a gallon) and I had 2 bottles with Gatorade. This drink got a lot of carbs, and because of the long walk you need it. My “food” was a lot of energy bars and trail mix. Due to the fact that you burn a lot of carbs, I had to make sure that my sugar level wasn’t too low. You need water and food for the way up and also for the way down. This is very important.

I informed the persons from the group that I had diabetes and what to do and what not to do when my sugar was too low or too high.

At that time I already had my Omnipod and I didn’t do any bolus during the day.

Hiking Boundary Peak, Nevada. 4007 meter was originally published on blog.joostvandermade.com

#boundary peak #diabetic #diabetis #highest peak #hiking #mountain #nevada #summit

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diabeticwarrior-blog1 · 8 years ago

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Introducing myself :D

Hey y'all! (Okay i have no followers but yeah…). I will first tell a little bit about my story of getting to the point where i am now.

At the age of 12 i was always thirsty and went to the bathroom way too much. Since my mom is a nurse, she recognized the sings and we went to te gp. My bloodsugar was around 36 (btw: in the Netherlands it is normal between 4 and 7. 8 and 9 is acceptable and above 9 is high and below 4 is low.) So, fast forward, I learned to inject myself and check my bloodsugar. The first 4 years or so went very well. I had all my shit together haha. Then depression hit me. This was not caused by the diabetes. But because of the depression, i just didn’t look after myself anymore. Bloodsugars as high as 25 for like 3 years. I was told i had only 10 more years left to live. When i reached the age of 20 I began to realise that i really had to do something to get healthy again and worked my fucking ass off hahaaha, my bloodsugars got a little bit better but still too high. And now that i am 21, it is slowly getting much better. my A1c is around 8.9% and is slowly going down.

By writing about my life with diabetes on here, I hope I will accept the fact I have a chronic illness.

Oh and btw: Since i was 13, i used an insulin pump. Till a few weeks ago, i always had a medtronic paradigm. Now I use the Mylife Omnipod :) very happy with it :D

#diabetes #diabetic #type 1 diabetes #insulin #actually diabetic

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type2diabetestreatments-blog · 8 years ago

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DexCom 7 — By God, She Likes It

New Post has been published on http://type2diabetestreatment.net/diabetes-mellitus/dexcom-7-by-god-she-likes-it/

DexCom 7 — By God, She Likes It

"Mom, you have a new beep!"

— my 13-year-old, apparently discovering my new CGM

I am back on the Dexcom (!), and feeling the truth behind the saying, 'third time's a charm.' I all but swore off continuous glucose monitoring systems more than a year ago after stints trying all three on the market (Dexcom, Medtronic Guardian, Abbott Navigator), in which the discomfort and inconvenience seemed to clearly outweigh the benefits.

But as you all know, I've been stumbling through a really rough patch with this demanding disease, and frustrated as heck, so willing to try just about anything to jumpstart better BG control.

To make a long story short, I ran into Dexcom's Northern California rep at the recent TCOYD conference here in Santa Rosa, and she convinced me to give it another go, for better or worse. She fitted me with a new trial system ten days ago, complete with pretty pink plastic cover (which picks up a lot of lint, btw).

Suddenly, I'm almost as excited about wearing a CGM as I was five years ago, when I was one of the first patients ever to wear Dexcom's first-generation product, the very first continuous glucose monitor ever out of the gate at the FDA.

Here's what I'm finding great about this 'more mature' system so far:

Physical comfort

Maybe I just got lucky with my first two sites, but I sure remember the sensor insertion and daily wear being a lot more ouchy. So far, I haven't felt one bit of discomfort with this thing. Here I must note that the Dexcom was always the most comfortable of the three if you ask me: the Guardian has that nasty long-needle inserter and shell-shaped sensor that dangles and pulls on things if you don't cover it with an oversized adhesive patch. Grrr. And the Navigator sensor is rather large, with that terrible awful plastic-latex adhesive backing that made me break out, captured moisture inside, and then made me break out more. Double grrr.

If the Dexcom Seven continues to be this comfortable to wear, I may not be giving it back unless they pry it out of my cold, dead hands (so to speak) — because site soreness and associated suffering was the main thing holding me back from using a CGM again.

Ease of Calibration

All the older models I used required either synching up two devices via special cable, testing with an extra fingerstick meter model I didn't like, and/or fussing with confusing and time-consuming input screens. No more! I absolutely love how easy it is to plug your numbers into the Seven. That's what it feels like, in fact, just plugging in a number now and then, rather than some complex process of "calibration" (why do I hate that word?)

All you have to do is scroll up or down on a nice large-print screen that displays the current reading, and you're there. The system also reminds you — but not too often — with a nice, clear intuitive message that it's time to punch another number in:

Accuracy!

I'm kinda blown away, to be honest. Back in the day (a few years ago is ancient history in the CGM world), these systems were lucky to be anywhere in the neighborhood of your current results from your fingerstick meter. That huge lag time was so frustrating. The combo of that and discomfort is what turned me off.

But check this out:

It doesn't happen like this all the time, of course, but so far been not more than 15ish points off, which I consider AMAZING.

Gear Overload

In short, I've become a big fan of the Dexcom 7. What I dislike most about wearing it has nothing to do with the particular model: it's just a pain having yet another gadget to carry around and keep track of — especially one that needs to stay close to my body or it goes "out of range" and is rendered useless.

I keep it in my purse, but keep walking upstairs or downstairs or down a hallway and forgetting about it. Grrr once more. And here's yet another charger to worry about!

While visiting with some colleagues at Alliance Health in Salt Lake City last week, I lifted up my shirt to show them my "double-gear" (OmniPod + Dexcom 7 sensor). You should have heard the gasps in the room! Funny how at the moment, I seem to be more aggravated by the parts that are not adhered to my skin...

Anyone with me on that?

Disclaimer: Content created by the Diabetes Mine team. For more details click here.

Disclaimer

This content is created for Diabetes Mine, a consumer health blog focused on the diabetes community. The content is not medically reviewed and doesn't adhere to Healthline's editorial guidelines. For more information about Healthline's partnership with Diabetes Mine, please click here.

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type2diabetestreatments-blog · 8 years ago

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The 2011 DiabetesMine Design Challenge: A Chat with Samantha Katz

New Post has been published on http://type2diabetestreatment.net/diabetes-mellitus/the-2011-diabetesmine-design-challenge-a-chat-with-samantha-katz/

The 2011 DiabetesMine Design Challenge: A Chat with Samantha Katz

We are now two weeks into the 2011 DiabetesMine Design Challenge — our annual diabetes/medical device design innovation competition that has sparked national attention — and it's time to get to know this year's Expert Judges. We've got a few new faces, along with some returning favorites.

From a design student at Northwestern University, to a winner of the 2009 DiabetesMine Design Challenge, to a product manager of insulin pumps at Medtronic, Samantha Katz has had quite a journey in medical device design. Although she doesn't have diabetes herself, she's quickly been immersed in the intricacies that we face on a day-to-day basis. We chatted with Sam about her thoughts on medical device design, how to make your bright idea successful, and how she sees design innovation in everything — including sewing machines.

DM) In this year's DiabetesMine contest video, you mentioned the iPad. What are some elements of current, non-diabetes technology that you love?

SK) One thing I always tend to pick up on, because I've been involved in packaging decisions at Medtronic, is the whole experience of the packaging when you buy a new product, and seeing if it's an intuitive experience. Are all of the components in the right place? Is the instruction manual easy to understand? Does it walk you through a step-by-step process of getting up and running?

I'm always looking to redesign clothes that I have, to change them up or make them look better, and I recently invested in my own sewing machine. When I took it out of the box, the instruction manual really bothered me. The first English page was followed by the first French page, so I had to keep flipping from page to page.

Sewing machines have not changed since the early 1900s. People really like the vintage machines. They've gone to electronic, but the needle movement and the dials are so antiquated. Meanwhile, I'm seeing different products that are really well-designed, like the iPad, that when you pop them out of the box you can start pressing buttons and using it right away. But the sewing machine has a very complicated set-up process and it's not at all intuitive. The whole product line of machines could use a refresh. I'm dying to redesign it!

I really wouldn't have thought of sewing machines as candidates for current redesign energy...

I wouldn't have thought of sewing machines either. It's not until you personally experience something, coming at it from a completely clean slate and being unbiased, that you truly have a pure opportunity to evaluate something. Otherwise you have a biased expectation for how it's supposed to work. This is probably true in medical device design as well.

Did you notice things about diabetes medical devices that people at Medtronic or people with diabetes didn't?

One thing always stuck me are the inserters for infusion sets. They seem a little... well, they seem very strange to me. I think it's because the first infusion sets were manual. People had to insert them themselves. The current inserters weren't created with users in mind; they were created with the best insertion in mind, not the best experience. You have to tilt your hand at an awkward angle if you want to insert in the side of your body. The devices are full of visible springs and they are not aesthetically designed, they are functionally designed.

For instance, with Omnipod, when you put in a pod, the needle is invisible. I think you'll see more things like that going forward. Users don't get that popping sound, or see the needle go in. Devices will become more ergonomic going forward too.

One thing I do think is great is the Medtronic mio. There isn't a separate inserter. That responsibility is out of the patient's hands. You just have to push the button. We launched it about a year ago. It's pretty easy to use.

How does Medtronic get input about their own designs? And have there been any recurring themes in what you hear from patients about what they wish existed?

We look at the types of outcomes or 'jobs' that patients are looking to complete rather than only thinking about features. If you're looking to have your blood sugar within a target range, we think of ways to achieve that outcome, rather than looking to improve our bolus calculator. We're constantly looking at new or better ways to achieve that outcome. Some of our efforts are similar to focus groups. Sometimes we do one-on-one interviews. Sometimes we are just observing to see how people interact with their diabetes devices — seeing how people are treating their diabetes while living their lives. It's important to be a fly on the wall.

When did you realize that good design is important for people living with medical conditions? Was it before or after you participated in the Design Challenge?

It was before. I had enrolled in a dual degree program at Northwestern University, and one of two degrees was in design. I didn't know what industry I wanted to be in. My experience had been in the consumer industry, so I started looking at automotive and consumer electronics. I never thought of medical devices, even though my father is a doctor. I never really thought I would follow him in any way. I always thought I'd be too queasy for health care or medicine. But a friend suggested heath care design, and I got an internship at Becton-Dickinson in advanced concept development. I had a really great internship, and just knew that this is what I wanted to do.

Before grad school, I was in investment banking. I worked with a wide variety of consumer companies, which gave me a good understanding of what to do once you have your product: how to monetize it and create a business around it. Design is great, but if you want to make it a lasting design, you have to be able to make money from it. You have to constantly improve your product and your business. A business background is important, otherwise good design is just really nice to look at.

As a past winner and also as someone who works for a medical device company, what advice do you have for budding inventors?

I think one piece of advice is that if people are truly serious about what they are designing, they should not ignore some of the big hurdles in the medical device industry. When I worked on my design for the design challenge, we thought about taking it forward. We met with attorneys and we realized Medtronic actually holds one of the key patents that we'd needed to commercialize our products. I think it's important to think about your design, but also think about the different business aspects in how you'd create your product — like legal and regulatory issues and how to manufacture a product on a larger scale. You should factor this stuff into your design if your serious about moving it forward. Design is awesome and essential, but there are a lot of other aspects to consider.

Thank you, Sam! No pressure on our contestants, of course, as part of our prize package will be help in working through these very issues. To learn more about how to enter the contest, click here.

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type2diabetestreatments-blog · 8 years ago

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Cellnovo = iPhone-ish Patch Pump System Worth Waiting For

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Cellnovo = iPhone-ish Patch Pump System Worth Waiting For

Ever since Insulet launched the Omnipod five years ago, the patch pump has been gaining steam as the must-have gadget for diabetes device companies. Many companies are in the works developing (or acquiring the technology to develop) their own, from market leaders Medtronic to newcomers like Debiotech with their Jewel pump. Now another company out of London, Cellnovo, is making its way on the scene, and getting some very hot press... but how good is their device really?

We spoke to Cellnovo's Chief Executive Officer, Bill McKeon, who's no stranger to diabetes devices and tools. He previously worked at Medtronic on their mobile initiatives. Cellnovo, a combination of "mobile cell" and "novo" for new, is both the name of the company and the name of their pump product, which is marketed as being smaller, thinner and supposedly better than any other patch pump on the market.

But to Bill, Cellnovo is not just another insulin pump. It's an entire "diabetes management system" built around the principles of mobile technology. Now to be clear, we're not talking about using your iPhone to manage your diabetes. Regulations aren't quite there yet. Cellnovo uses "the principles of wireless transmission of data," connecting a device to other devices or to the Internet, which is similar to how your iPhone or Blackberry works.

Like many others, the folks at Cellnovo realized that if you could share a patient's data, it would help physicians better understand their day-to-day life. It would also allow patients or caregivers to regularly see how the "big three" (blood sugar, insulin, exercise) affect their diabetes management. The hub of the Cellnovo system is the mobile handset, which not only acts as the blood sugar meter and controller for the insulin pump (like the Omnipod PDM, but smaller), but it also transmits the data to a centralized server, which then sends the data on to a web-based platform (akin to CareLink) or it can send the data via text message to a cell phone. The handset also features a food library, and the insulin pump includes an "accelerometer" that records when and for how long you were active. Insta-logging, neat!

Simple, easy and... pulsating?

Although Cellnovo bills itself as an entire system, not just a single product, the pump itself is the first thing we consider when choosing pump therapy. How big is it going to be? Is it comfortable to wear?

Fortunately for us, Caroline Parker, a UK blogger at Diabetes Daily, has had a chance to touch and feel the system. She describes her impressions: "The pump itself really was tiny. The micro motors these guys were building were simply amazing. The entire unit was around half the thickness of the Animas pump I was wearing at the time and considerably smaller than the Omnipod dimensions."

The Cellnovo patch pump uses a Velcro-like adhesive strip to attach to the patient's body, so it is removable at any time. Although described as a "patch pump," there is some tubing involved. But it is much shorter than traditional tubed pumps, and in general meant for more flexibility.

It may seem strange, but the Cellnovo pump is a pulsatile pump. Unlike traditional insulin pumps which use a motor to push insulin out of an enormous barrel (from 180 to 300 units), the Cellnovo pump uses a "wax actuator," which takes insulin from the larger reservoir and moves it into a smaller chamber. Once the smaller chamber is sealed, the insulin is then delivered. This allows the pump to deliver insulin with a much higher precision. According to Bill, most insulin pumps actually deliver insulin with a plus or minus 20% accuracy rate because of a siphon effect, as reported in the January 2010 issue of the Journal of Diabetes Science and Technology. That means if you give yourself one unit of insulin, you could be getting as little as .75 units or as much as 1.25 units! The Cellnovo pump reportedly drops the error margin to a staggering plus or minus 1-2% rate.

Cellnovo's entire platform is clearly based on the principles of Apple technology. The iPhone and iTunes were repeatedly mentioned by Bill in our conversation, in reference to how "seamlessly easy" and intuitive the products are. The goal is to make Cellnovo as easy to use as an iPhone, and everything from their touch-screen handset to their packaging reflects an innovation and sophistication that is currently lacking in medical devices.

Blogger Caroline Parker also writes, "The most surprising thing though is how familiar that control device looks. It took me just a few moments to realize that bears more than a passing resemblance to a touch screen cell phone and most specifically an iPhone - even down to the 'slide to confirm bolus' action. And once I realized that, I couldn't help but think that maybe Amy Tenderich's Open Letter to Steve Jobs had been answered after all."

Bill explains the mindset behind it: "You don't want to be a PhD in pump therapy. You just want to live your life." (don't we know it!)

The mobile aspects of Cellnovo's technology will benefit many parents who struggle to manage their child's diabetes from a distance. For instance, if your child tests their blood sugar while away from home, you can send BG results automatically via text message. Although the "coolness of the technology" is a big appeal, Bill says the real aim is to "bring peace of mind to unburden patients."

Bill also hopes that the company's information hub, Cellnovo Online, helps providers and patients skip over the whole "so what have your blood sugars been lately?" step, because your doctor can see all your information in real-time. Physician adoption is of course TBD, because this system is still in the works, but the company apparently has had "many positive conversations with doctors."

Keeping Green

One of my biggest beefs with diabetes medical devices is the huge amount of waste created. Although the Cellnovo pump still requires the usual set changes, etc., the pump itself is not a throw-away, more like a tubed pump that can be used over time. The throw-away items here are the infusion sets and the insulin reservoirs only. In addition, the pump is rechargeable. Cellnovo provides consumers with two patch pumps, one to use and one to recharge. Instead of constantly tossing out used batteries, this is one way we can reduce our carbon footprint.

Safety and Privacy

Anything mobile always gets me a little nervous... all my data floating between a mobile handset and cyberspace? Isn't that dangerous? Cellnovo gets that, so they use the exact same encryption service that international banks use to wire money around the world. Plus, Cellnovo meets all HIPPA requirements and never associates your data with your name. Privacy is guaranteed. According to Bill, that makes the FDA very comfortable with the idea of using this mobile technology.

The Big Bad FDA

So... how does the FDA feel about this newfangled gadget? After last week's drama with the still-delayed EnLite sensors, some people might be wondering if the Cellnovo insulin pump is just another pipe dream.

"They told us that it's the best user interface they've ever seen on a medical device," Bill shared. "We're proud of our relationship. We've listened to them."

Although FDA procedures are often a sticking point for PWDs, Bill sees it in another light: "Their job is to protect people. If companies are doing that usability testing ahead of time, we shouldn't blame the FDA. We should thank them for raising the bar higher. We're going to get better and safer products out there. That's great for the industry... The FDA is more progressive than people give them credit for. They have a tough job. They have to protect the community they serve. No one wants to read that someone was harmed or died by a product on their watch."

Cellnovo has worked closely with their team at the FDA, which has given feedback and advice on what they will require of the company, and says it's crucial for medical device companies to have even higher standards for their devices than the FDA does.

Dollar $igns

It's hard to get your hopes up when you're terrified they'll be dashed by your dumb insurance company, but Bill explained that the Cellnovo insulin pump is actually cheaper for payers. Like the Omnipod, which has a much lower upfront cost than tubed pumps, Cellnovo is confident that insurance companies will support their system.

The low upfront cost for Cellnovo "would be a fraction of what you would be paying when moving onto a conventional system," Bill says. Although he couldn't give us specific pricing figures, he claims that over the four years of a typical pump lifespan (when the warranty ends), the Cellnovo pump will cost payers less than both a traditional tubed pump and less than the Omnipod.

So where are they now?

The Cellnovo insulin pump is gearing up to launch in Europe, led by the same guy who led Novo Nordisk's production of insulin pens. Cellnovo has actually been prepping and manufacturing for a couple years now, so they are ready to meet the demand.

Alas, that demand in the US may have to wait a little while longer. Cellnovo will apply for 510K status with the FDA and begin clinical trials in the fall, but there is no guarantee when they might appear on the US market. Bill refused to even wager a guess, saying he'd much rather be conservative and wrong than over-promise and not deliver (a common theme we're hearing these days...).

In addition, they are working on several partnerships with blood glucose meter and CGM manufacturers, but still nothing's approved. Bill was tight-lipped about what this integration could look like...

Which of course brings us back to the recurring frustration over new technology we want, but can't yet have. We get that. Cellnovo might not be something you should hold your breath for, but it certainly is an exciting prospect! And hearing a CEO talk about life with diabetes and really getting it is nice.

OK, it doesn't take away the pain of this disease in the present, but it is nice to know that the devices on the horizon aren't just the same-old, same-old with a new name. Some people really are trying to revolutionize how we manage this damn disease.

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type2diabetestreatments-blog · 8 years ago

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Diabetes in the UK: Free Care, But Behind the Times?

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Diabetes in the UK: Free Care, But Behind the Times?

Diabetes is certainly not created equal, and it's even more varied when you take into account the various ways countries manage their health care system. Over the past few months, in our new international series, we've peeked into the lives of PWDs in Spain, Germany, Canada and Australia, and this month we're taking a hop across the pond to visit Becky Thomson, a resident of the United Kingdom (which of course encompasses England, Scotland, Wales and Northern Ireland).

Becky is a 26-year-old administrative assistant at a theater in York, England, where she's lived with type 1 diabetes for about two years. She writes the blog Instructions Not Included and tweets away at @instructionsni. She currently uses an Animas insulin pump, but as she tells us, that's not exactly common in the UK...

A Guest Post by Becky Thompson

So the UK — land of hope and glory, right? — we've spell with more U's than you can shake a stick at, and a whole other system of blood glucose measurement. But apart from that, how different is life over here in terms of diabetes?

Speaking from this side of the 'pond,' so much of what I hear about from the other side is like a labyrinthine mystery. And when I was diagnosed two years ago, at the age of 24, having had relatively little interaction with the world of doctors, prescriptions and juggling appointments, I was completely lost. So, since you probably know about as much about dealing with all this in the UK as I did, let me give you a whistlestop tour of our system.

The UK is (in my opinion) extremely fortunate in that we have access to the NHS (National Health Service). Scotland and Wales have their own branches of the NHS — oh-so-creatively named NHS Scotland and NHS Wales. Northern Ireland has a similar institution to the NHS, called HSC (Health and Social Care in Northern Ireland), which operates in much the same way. The NHS is free at the point of use — I pay my contribution to funding through paying my taxes and National Insurance, which is deducted from my wages, rather than having to purchase 'health insurance.'

In the UK, you're issued an NHS number, which entitles you to be able to go to a doctor without worrying about having to pay a fee. The same goes for hospital admissions. During my five-day stay at diagnosis, I was never presented with a bill, nor did I ever expect one. I've never paid for test strips, insulin, needles, or now, pump supplies.

Most people pay a prescription charge, of £7.20 (around $12.00) each time they need a prescription filled. This is just an England thing; Scotland and Wales have done away with it. However, having a chronic health problem, I get sent a nifty little card, which means that I'm exempt from paying charges, which I'm very glad for. Even with free health care, this would still make a bit of a hole in my (not very well-lined) pocket.

I have what's known as a GP (General Practitioner), who I see for most health issues. There's often some confusion about whether the GP's practice or the hospital clinic is supposed to look after the diabetes care of people with type 1. I happen to go to the hospital's diabetes clinic, where I have my endo, who I see once a year, and access to a team of four DSNs (Diabetes Specialist Nurses). Normally, you wouldn't actually have contact with as many, but for various reasons, I've dealt with all of them at some point or other! For questions about my care, the DSNs are my point of call on all matters diabetes-related. I'm free to call up or email whenever I need to, and I generally see one of them about every six months as a matter of routine.

In terms of treatment? Most people here are on MDI. I was started off on twice-daily mixed insulin, which didn't work at all for me. I quickly moved on to Lantus and Novorapid. I'm very lucky in having access to an insulin pump, as they're very hard to get hold of over here. Last time I checked, it was only 2-4% of type 1's who had one.

For CGMs, the number will be even lower. I've never seen one in person, and I don't dream of getting hold of one within the next 5 years. This is mainly because each area of the country gets a specific amount of money from the NHS budget to spend. I'm fortunate that my area has an extremely well-maintained budget, which gives me opportunities that people in other areas don't get. It's what's 'lovingly' referred to as a 'postcode lottery,' which I've happened to come up trumps on. Ah well, as I don't gamble, it's the only one I'm likely to, despite what many emails seem to tell me about the Nigerian lottery.

Technology seems to be 'drip-fed' though over here. It's a long time before we get anything new. Omnipod took its time, we don't have the Animas Ping or Dexcom. But we are getting the new Vibe (Animas pump & Dexcom combo), so perhaps things are looking up.

So you have things we don't have, and we have things you don't have. But all in all, we still probably carry around the same amount of gear on a day to day basis. The rules are a bit different, but we're still playing the same game. Just that our blood glucose numbers are a bit different, and I would love to get glucotabs in flavours other than raspberry or orange.

Thanks for that little jaunt into your world, Becky. Everything in life is a trade-off, for sure!

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type2diabetestreatments-blog · 8 years ago

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Grand Prize Winner Pancreum: A Small, Modular Artificial Pancreas

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Grand Prize Winner Pancreum: A Small, Modular Artificial Pancreas

The Pancreum closed loop (automated insulin + CGM + glucagon) system that won a Grand Prize in the DiabetesMine Design Challenge this year may look like a pipe dream, but designer Gil DePaula assures us it is "visionary but real."

Have a look at the video, below, and also Gil's company website.

This is what the small company's founder says about this Pancreum AP system:

"The glucagon part is definitely a futuristic concept — because there's no predicate device for glucagon delivery with the FDA, so that's a huge question. But the insulin pump and CGM are as real as OmniPod was when I joined Insulet in 2002 (he worked there 5 years). And now that's real and on the market; there are predicate devices out there. So if I want to introduce a new disposable tubeless insulin pump, I can do it. I won't have to climb mountains."

— Gil DePaula, Pancreum LLC

Based in Fort Lauderdale, FL, Gil DePaula is a software and electronic engineer who previously worked on the Guardian Real-Time CGM at Medtronic Diabetes, and also helped launch OmniPod with Insulet Corp. He went out on his own a few years ago to pursue his dream of developing a flexible, open-platform, high-performance closed-loop system for diabetes.

We interviewed Gil about Pancreum this past winter, before anyone was thinking in design contest mode; he hadn't even heard of the competition back then. Once he learned about the contest, he decided it was worth "going public" with his only-partially-patented ideas, because above all, he wants to see the diabetes device market evolve. "I think we're stuck with too many old ideas," he says.

"When I saw all the other videos and entries this year I was nervous. I wondered if we had a chance. I still can't believe we won!"

We talked with Gil again last week, to get some more detail on where he is now in the process of developing the Pancreum system. One thing he was excited to share was that he'd connected with last year's DiabetesMine Grand Prize winner Mauro Amoruso, a professional designer based in Turin, Italy, who has helped Gil refine the form and function of the Pancreum system.

DM) I think the big question for many people looking at your design is, how do the cannulas work?

GdP) The pump cannula is similar to OmniPod, with automatic insertion, except that OmniPod has two springs and we hope to need only one.

In the OmniPod, the cannula is wrapped around the needle. It inserts, and a second spring fires and pulls the needle out and leaves the cannula. We're working to make this a one-step process.

For the CGM, if the needle is the cannula, which is currently the case with most models, then you also need just one spring. But current CGMs have manual insertion devices. We hope to do away with that and offer automatic insertion there too.

Right now our whole circular unit with two wedges (the insulin pump and CGM portions) is about the size of the OmniPod.

If it's so small, how can it house enough insulin to be useful for most patients?

We think the reservoir size is going to be 400 units, so it's actually 2x the capacity of the OmniPod reservoir.

We've designed it mechanically — a 400-unit reservoir and drive mechanism — that fits inside our little 'wedge.' It's a narrow and long device.

So you already have working prototypes of all the pieces of this system?

I have a physical prototype that I'm bringing to the ADA conference this week. It's not the black one you see in the video — that looks like Darth Vader! — but a cooler color. The prototype is now much smaller too. It's half the size of a cell phone.

The only thing that hasn't been touched in real development work yet is the mechanical part — the drive mechanism and reservoir I mentioned. We've designed it, but haven't created the necessary plastic pieces yet.

For me to have someone design an electronic board that fits inside the footprint we've created, I need money. That's why we're looking for investors now.

What will the system offer patients, beyond connecting the pump and CGM? Like automatic shut-off of insulin if you dip too low?

This is not just sticking several devices on a patient. We'd like to take the functionality a step further. For example, if you've had to correct several times in a row, should you not increase your basal rate? In other words, if the system has to suggest correction boluses frequently, it's also gonna suggest a basal rate increase as well. It will also suggest decreased basal rates, stopping basal rates, and will take insulin on board (IOB) into account — multiple features like that.

And also automatic shut-off should definitely be part of the system once the FDA will allow it!

So that and glucagon delivery are the biggest FDA hurdles?

Yes. I don't understand why FDA picks on glucagon so much. Unlike insulin, if you mess up with glucagon (or automatic shut-off) all you're gonna do is raise somebody's BG levels for a while. But if you mess up with an overdose of insulin, you're gonna do some serious immediate damage.

Isn't the Artificial Pancreas Project already testing with glucagon delivery in the mix?

We've gotten a lot of information from different people, including Dr. Russell from Massachusetts who's done testing using all three devices on pigs. He's doing a lot of great work, but still there are a lot of questions to be answered:

How much glucagon do people generally need for six-day wear?

Does glucagon's viscosity effect how wide the cannula needs to be?

What is the glucagon ratio? As in how much does one unit raise your BG?

Do we need basal rates for glucagon or just boluses?

These are all questions to be answered, and it will take time.

So what's your next step? What will you do with the prize money, for example?

We're developing an app that runs on Android right now. We're doing this first because of Apple — they require too much before you can develop something that can connect with their platform.

I'll use the prize money towards improving the Pancreum Android App and building a real-size electronic prototype for the CoreMD and wedge(s).

We'd like to get in touch with others who did CGMS software entries (like mobiLIFE) to discuss possible collaborations.

That's great, Gil! Anything to add?

I wanted to say that as soon as I saw the BLOB entry, I thought from the start this design will win! I don't have diabetes, but one of the oldest technologies in the field is insulin pens. The BLOB idea totally revolutionizes that space.

We hope so, Gil. And as one of readers commented on the winners' announcement: Go Pancreum!

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type2diabetestreatments-blog · 8 years ago

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BMX Rider Rolls Hard with Type 1

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BMX Rider Rolls Hard with Type 1

We've talked to all sorts of athletes over the years, from skiers to swimmers to football players. But today, we are introducing our first-ever BMX racer! Matt Neal is 30 years old and was diagnosed with type 1 diabetes just a few years ago at age 28. Despite his fairly recent diagnosis, Matt isn't letting diabetes slow him down. For those who are as unfamiliar with the sport as we are, BMX is short for "bicycle motocross" and it's a form of extreme bicycle riding involving off-road racing on an obstacle course, complete with sharp turns and dangerous hills. Not for the faint of heart!

Matt has been BMX racing since he was a kid and he's continuing to pursue his passion as a competitive athlete in Mesa, AZ. He recently founded Team Type 1 BMX, which as of now is an "unofficial" part of Team Type 1. That means they use the Team Type 1 logo and name, but Team Type 1 as an organization does not manage the BMX team. They plan to become more formally merged next year.

We chatted with Matt about the literal and figurative ups and downs of living with diabetes while BMX racing:

DM) How did you get into BMX racing?

MN) I have been very active my entire life. I always enjoyed being outside and playing sports when I was a kid. I went to school with a few kids that raced BMX and I enjoyed riding with them after school. I kept bugging my parents to let me start racing with them. Finally, my dad took me out to the BMX track for my 10th birthday. I was hooked! I loved racing and started taking it more seriously after a couple of years.

I was very fortunate to be able to travel around the country racing different events. I was even more fortunate to experience a great deal of success in the sport that I loved. I was top 10 nationally in my age group for several years and I even got second place at the BMX World Cup when I was 18. I turned pro for a few races at the end of my career before hanging my bike up to finish my degree.

What happened when diabetes entered the picture?

Fast forward about eight or nine years and I got the itch to get back on my bike. I started riding again and went to a couple of national events. I was riding decently for not racing for so long but I was a little off. I didn't feel like I had the power that I should and I started losing weight. A LOT of weight. I couldn't gain a pound to save my life, and I knew something was wrong.

I completed a health screening at work and my fasting blood glucose was 358 — and my fears were confirmed. I had diabetes. I was officially diagnosed February 20, 2009, with type 1 at the age of 28. Believe it or not, I felt very fortunate to have a manageable disease. I took some time off of my bike again to get a handle on my blood glucose, and I knew I wanted to race again. So that's exactly what I did! I started racing at the beginning of the 2010 season.

When did the idea for diabetic BMX team come into play?

When I was diagnosed I knew I wanted to turn my diagnosis into something positive. BMX has been such a big part of my life and I thought I could use the sport to inspire others living with diabetes as well as help educate others about the disease. So I decided to start a team. At first, it was myself and three friends who I grew up racing with.

I was at a national race in Tucson, AZ in August of last year having dinner with my wife. I was wearing a DESA shirt that said "I run on insulin" on the back. A girl approached me as we waited for our food and asked if I had diabetes. I told her I did and she said her brother did as well. I went to their table and met Owen. He was 11 years old at the time and was racing BMX with type 1 diabetes, just like me. I chatted with Owen and his mom and explained what I was doing with the team for the 2011 season. They were very interested and we exchanged information.

This is basically how the team has grown. Someone sees one of the riders wearing our gear and asks about the team or sees an article in a magazine or newspaper and contacts me. It has been amazing! We literally grew from five riders, two with type 1 to 11 riders, eight with type 1, and the season isn't even over yet!

How did you hook up with Team Type 1?

I met Phil Southerland, founder and CEO of Team Type 1, at the Tour of California last summer. I explained what I was doing and expressed my interest in being part of his organization. I figured that Team Type 1's mission and mine were nearly identical, so it was a good fit. At the same time, BMX is very different from road racing. BMX is more of an extreme sport and caters to a younger, more family-oriented crowd. Phil was interested in getting his organization involved in BMX but didn't have the funding available to fully support us. As a result, we have been self-funded this year and have our own group of sponsors who have helped us out: Diabetes America, OmniPod, Fly Racing, Adventure Bicycles, JDRF, and Integrated Diabetes Services.

Going back to your "late" diagnosis at age 28, how did you actually handle the transition from a 'carefree life' to a life with diabetes?

I'm still a bit of a newbie! The transition was probably less frightening for me because of my background. My degree is in exercise science so I already knew what a pancreas is, what insulin does, what a carbohydrate is, etc. For me it was simply a matter of figuring out how everything worked for me and my lifestyle. I am thankful I already knew some of the basics before I was diagnosed because it definitely made things easier.

Weren't you nervous that diabetes would impact your racing success?

Diabetes has not impacted my performance at all. I won the second national event that I raced after being diagnosed. I've placed top 3 in every national main event this year with the exception of a few crashes. The main difference now is my pre-race preparation. Before, I could eat whatever I wanted whenever I wanted to before a race. Now I am constantly thinking about how much insulin I have on board, approximately how long until my next race, etc. so I can be at close to my target as possible.

But surely diabetes impacts BMX riding in some ways... How do you deal diabetes when competing?

Diabetes does add a whole new challenge to racing BMX. I test my glucose levels a LOT on race days. National races are especially difficult because you don't know exactly when you are going to race and the races take place all weekend long. They are also challenging because my adrenaline tends to raise my BG levels. My target level for race time is 150 mg/dL so I always keep my meter, insulin, and carbs close by.

The main thing I try to do to optimize my blood glucose at races is to make small adjustments. I try to eat small meals and snacks throughout the day to avoid having big spikes or glucose crashes. It also helps so I don't have a really full stomach when I need to race. I tend to have a few extra carbs at breakfast to bring my levels up. If I have a tougher race coming up and I know my adrenaline will be kicking in, I will try to get my blood glucose up to about 120 mg/dL because I know that adrenaline will take it up even higher while I'm warming up. If I know that I have a while before I race I will take a small correction to bring my levels back down to 100 mg/dL and then eat something to pick me back up when my next event gets closer.

After the race day is over, I try to have a few extra carbs at dinner to replenish/refuel and make a small correction to bring my levels back down. I make sure not to over-correct because I tend to run lower the day after, as my body is recovering and using up more glucose.

Do you use a pump or CGM to manage your diabetes?

I use the Dexcom CGM system and OmniPod to manage my glucose levels. It is awesome to have the extra data from the CGM to look at trends. It helps me to keep my levels stable all weekend long and makes it easier for me to be close to my target before all of my events. The OmniPod really helps me fine tune my BG all weekend long and makes it quick and easy to make any adjustments. I am currently the only rider on the team using the OmniPod, although Owen, our 12-year-old, is getting one soon. A couple others are using the Medtronic pump/CGM.

BMX is such a wild sport. Have you or the others had any problems with pumps coming off while riding?

To my knowledge, none of us have had any trouble with the pump coming off during a race. I personally choose to use the OmniPod system so I can place it on different parts of my body when I ride. I usually have it on the back of my arm when I race so there is a smaller chance I will fall on it if I crash. I can share that I've had some pretty crazy crashes and the pump was still attached and working fine when I got up!

What message would you like to convey to our readers? Especially those who might be afraid to do something because of their diabetes?

I always say don't let diabetes stop you from doing anything. Diabetes doesn't have to hold you back or slow you down. If there is something that you want to do, go for it!

Matt will racing the Black Jack Nationals in Reno, NV, Sept. 2-4, while the majority of the Team Type 1 BMX team will be at the US Open Nationals Sept. 30- Oct. 2. If you can't make it out to cheer on the team in person, check out this awesome video of Matt riding BMX!

Disclaimer: Content created by the Diabetes Mine team. For more details click here.

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Ask D'Mine: On the Way to Insulin + An IOB (Insulin on Board) Pump Question

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Ask D'Mine: On the Way to Insulin + An IOB (Insulin on Board) Pump Question

If we had a dollar for every time "What the heck??" was uttered in managing diabetes, we'd probably have enough funds to find the cure ourselves! Luckily, we thrive on the never-ending mysteries of diabetes here at our weekly advice column, Ask D'Mine, hosted by veteran type 1, diabetes author and community educator Wil Dubois. This week, Wil tackles high BGs in a type 2 PWD, and how insulin-on-board is calculated differently in various insulin pumps.

Need help navigating life with diabetes? Email us at [email protected]

Jerry from California, type 2, writes: I was diagnosed five years ago and at the time I had an A1c of 11.2. A few months later, I found the Atkins Diet and pretty much adopted it as a way of life. It worked great. My A1c dropped to the 6.5 to 6.2 range and stayed there I stopped testing because the results didn't vary much, never above 150. A few days ago, I tested before dinner and I was 290. I tested four more times because I couldn't believe the results and the average was about 280+. Cut to end: I went to the lab for the official results and my A1c is now 10.1. My diet's the same, I'm not sick and nothing major is happening in the stress department. So my question is this: what could possibly be going on? Is this the natural progression? Am I on the way to insulin injections? Or is it likely that things will return to normal?

Wil@Ask D'Mine answers: This is the natural progression. You are on your way to insulin (eventually). Things won't ever return to "normal." Well, actually, that's a lie, because things already are normal. This is normal. Type 2 diabetes is progressive. And I don't mean blue-shirt, granola-crunching, left-leaning progressive. I mean like the relentless march of time progressive. Type 2 diabetes gets a little bit worse every day. It grows stronger and meaner over time.

Here's what happened to you: After your diagnosis you made a major change in your lifestyle. And good for you! That's hard work. You started a diet that minimizes the types of foods that turn to sugar quickly. You most likely lost weight, too, which for a time reduced your insulin resistance. You got your diabetes under control using shear grit.

But you didn't cure it.

It was still there. Hidden under the surface.

Still growing. Getting stronger every day.

You took your eye off the ball, and diabetes bit you in the butt. It has a tendency to do that. The lesson here is to never turn your back on diabetes. Don't trust it. Always keep one eye and a glucose meter on it. Sometimes type 2 grows slowly and steadily, other times it grows in leaps and bounds. But it always grows.

So that's what happened. But what happens next? You asked if you are on your way to insulin. The fact is, all type 2s are on their way to insulin. If you live long enough, you'll join our club.

No fear.

This doesn't mean you need insulin tomorrow, although it should be one of the options on the table for you and your doc to kick around. But there are other options both in pills and in shots that might make more sense in the meantime. One thing is for sure, you've adopted a pretty radical lifestyle (and please go get your cholesterol checked, OK?) to control your blood sugar, and your diabetes has outgrown it. I'm not seeing much left that you can do in terms of how you eat, to control your diabetes.

It's time to open the medicine cabinet.

;

Larry from Virginia, type 3, writes: My daughter has been on the OmniPod for the last two years. As I am sure you are aware, OmniPod calculates on-board insulin differently than the other major pump manufacturers. Basically, OmniPod excludes insulin that was designated for specific carbs from the calculation. I would be curious to know your take on the matter.

Wil@Ask D'Mine answers: For non-insulin shooting folks, an executive summary: Insulin can be used to both lower blood sugar or to attempt to keep blood sugar from going too high in the first place (or so we hope). Modern fast-acting insulins take about 20 minutes to start working, hit their peak at two hours and call it a day after four hours. Damn! Where can I find a job like that? Anyway, anyone shooting insulin is theoretically at risk of stacking up too much insulin if they take more than one dose in a four-hour period, and too much insulin can lead to low blood sugar, which can be dangerous.

All of that said, there are many, many times when you do need to take insulin twice (or more) in a four-hour period. So you have to try and keep track of how much insulin might still be floating around in your body from the last dose when you think about taking your next one. This is one area where an insulin pump can theoretically excel -- it can keep track of all the insulin given and when, how long it's going to last and how strong any remaining insulin on board (IOB).

There're two broad ways to calculate this insulin still on the job; but you're misinformed about the non-OmniPod pumps being different - all the major pump choices here in the States go about keeping track of this already-taken insulin in pretty much the same way. All the current pumps assume that insulin given to cover food will get sucked up by the food, and the only spare insulin is the insulin taken for corrections. So they only track insulin from corrections. Oh, the devil is in the details, of course, and there's quite a bit of difference in the mathematics of how they go about doing that. Ãœber CDE GaryScheiner discusses the finer points in detail here.

But back in the day (several years ago) there was a pump called the Cozmo that was radically different than the current choices. Sadly, like the Triceratops, it's now extinct. Well, nearly extinct, anyway. A few of us old-timers are still holding on to our aging Cozmos, and the #1 reason for this is the different way the Cozmo pump calculates on-board insulin. It assumes that all insulin matters and it tracks both meal boluses and correction insulin.

"My take" on the matter is pretty strong: I think the current state-of-the-art pump-thinking sucks and is dangerous. Criminally so. And I'm not the only one who thinks that.

Now, I'm a pump vet and a certified pump trainer. My personal, professional, and recreational life is diabetes 24/7/365. You might think I'd be an awesome carb counter, that I always take the right amount of insulin for my food, and would be just fine with any state-of-the-art pumps.

You'd be wrong.

I get my mealtime insulin wrong as often as I get it right.

The idea that my best-guess carb count will always nicely suck up my meal insulin is crazy. I think a good insulin pump needs to recognize the reality in the trenches, and the reality in the trenches is that, like me, most of us PWDs reliably get it wrong a lot of the time. A pump that keeps track of all the insulin on board is safer, more realistic and a better service to its wearer than a pump that ignores more than half the insulin you take.

When your daughter's OmniPod came on the scene, the OmniPod folks apparently surveyed endos to see if the "Medtronic Way" or the "Cozmo Way" was more popular. Apparently, 51% percent of endos preferred the Med-T system so that's what OmniPod went with. Why on earth they didn't just create a way for the user or doctor to choose either is beyond me.

When the Solo pump was first approved there was a lot of excitement as they were trumpeting the fact that the new patch pump would use the Cozmo Way of tracking insulin in the bod. But they've since been bought by Roche, and only time will tell if this feature will change by the time the device actually gets to market.

There are a lot of reasons to choose one pump over another, but right now the insulin-tracking feature of the current pumps track insulin still on the job is not one of them.

This is not a medical advice column. We are PWDs freely and openly sharing the wisdom of our collected experiences — our been-there-done-that knowledge from the trenches. But we are not MDs, RNs, NPs, PAs, CDEs, or partridges in pear trees. Bottom line: we are only a small part of your total prescription. You still need the professional advice, treatment, and care of a licensed medical professional.

Disclaimer: Content created by the Diabetes Mine team. For more details click here.

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DSMA April: The Power of Support

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DSMA April: The Power of Support

The Diabetes Online Community is all about support, but what about in-person diabetes support groups? This month's Diabetes Social Media Advocacy (DSMA) Blog Carnival asks, "Describe your ideal diabetes "support group"? What would you discuss?" Amy's really concentrated on getting most of her support from the DOC, but I've attended local support groups on-and-off for the past 18 years. So this month, I'm sharing a little about why I love IRL (Internet-speak for "in real life") diabetes support, plus a bit about a new project I'm working on!

I love support groups. In any shape or form, hanging out with PWDs is one of my favorite things to do. When I was growing up, most of my diabetes support came from once-a-year diabetes camp and the occasional diabetes event hosted by JDRF or ADA.

In high school, a wonderful group of parents founded a diabetes support group for families dealing with diabetes. The group registered as a non-profit organization, and with a healthy list of sponsors, they were able to bring in well-known guest speakers, like Dr. Bruce Buckingham. Although it was geared for parents, I spent time there coordinating the childcare, and managed to form my own mini support group with the other teens who babysat with me.

Unfortunately, college was a desert as far as diabetes support goes. It was almost impossible to find anyone with diabetes, because it's is an invisible illness and most college students aren't interested in talking about a disease when they could be with friends, at the bars, or, you know, studying. Thank goodness for the DOC!

When I moved to the NYC area in 2007, I was lucky to find two new diabetes support groups: the NYC Type 1 Diabetes Meetup Group and the Adults Coping with Type 1 (ACT1) Diabetes group. Because of grown-up life obligations, I'm not able to make every meeting, but I have formed some really amazing friendships and I always know I can count on them for a hug when I need it.

Still, if you're reading this blog, you might be wondering: why do I need an in-person support group? Isn't getting advice and support what the DOC is all about? Why can't I just stay online? It's so easy!

Good question! Here are a few of my reasons for going IRL:

1. The Dialogue. Message boards, Facebook and Twitter are all excellent ways of exchanging info and support, but they can be sometimes limited in allowing a real dialogue with someone. It can be difficult to ask follow-up questions or share detailed stories when people are constantly popping in and out. Plus, there are certain (*wink wink*) conversations that you don't necessarily want to broadcast to the entire Internet!

2. Seeing is Believing. Kinda cheesy, I know, but sometimes it's hard to realize just how many other people go through the same crap as us until you see it in action. One thing I hear often from new people at support groups is how cool it is to see other insulin pumps, to see folks testing their blood sugar, or to hear the alarms or beeps of our medical devices.

3. Demonstrations. I have lost track of the number of times I've lifted my shirt to show off my insulin pump set on my tummy, or handed over my pump to someone so they could see how a bolus wizard works. (Brings a whole new meaning to the phrase, "Don't touch that button!") Many of us might not know anyone who uses another type of diabetes technology. While online photos of an OmniPod or Dexcom might look intriguing or answer a few basic questions, it's not until you can viscerally touch and see a device in action that it becomes clear how it could fit into your life.

So those are some reasons I think in-person support groups are awesome. But what do I specifically look for in a support group? Here are my criteria:

1. Close proximity to where I live. One of the major bummers of living so far out from NYC (although I'm considered in the metro area, I'm 35 miles away) is that it takes so long to get anywhere. On the weekends, it's not a problem, but I work from home. Heading into the city — approximately one hour each way — for a two-hour dinner or meetup is often not the most appealing idea. Having folks nearby also makes spontaneous dinners, coffees and emergencies a little easier to handle.

2. People in my same life situation. It makes sense that people I would most relate to are those who are type 1's in their late twenties or older who are working, like me. I'm not a parent or a person with type 2 diabetes, so our life experiences wouldn't overlap very much.

3. Desire to learn and manage diabetes better. I enjoy interacting with folks who want to discuss diabetes technology, tricks of the trade, and the latest research. Complaining and venting are certainly appropriate for support groups, too, but I like the kind of support groups that lift me up and leave me inspired and motivated. I don't just need a chorus of agreements when I complain about diabetes. I want emotional support, but also practical tips to help solve some of the problems I encounter.

A few weeks ago, I decided "close proximity to where I live" is the one issue I have with the wonderful NYC support groups I've been visiting. As much as I love the people, being in the city, they are quite a bit of a distance from where I live and work. I have been itching to meet folks a little more local since moving to Westchester County a year and a half ago. I haven't found any existing support groups here yet, so I'm doing what I always do when what I want isn't available: I'm starting my own!

How am I doing that? Well, the concept for the group is still new, and I haven't even held my first meeting, so I can't say I'm an expert on the subject. I plan to host one meeting a month, alternating between a weeknight and a weekend night. A few things I'm doing to spread the word include:

- Creating a main page on Meetup.com. Folks can join and receive notifications about when the next meetings will be.

- Posting about it on local JDRF / ADA Facebook walls.

- Emailing local newspapers and blogs about my support group to spread the word.

- Designing a flier to promote the group and sending it to local diabetes clinics, doctors and educators; you can also send it to local pump reps if you know them.

Our very first meeting (a dinner at a local restaurant) is coming up in a couple of weeks, on Tuesday, April 24. If you happen to live in Westchester (NY) County or Fairfield (CT) County, I hope you can make it! I'm also totally open to suggestions for how to promote and organize my new group. This is the first time I've ever organized a support group and I'm excited to see where it goes from here — IRL!

* This post is our April 2012 entry in the DSMA Blog Carnival. If you'd like to participate too, you can get all the information you need here. *

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ADA 2012: Diabetes Company Updates from the Expo Floor

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ADA 2012: Diabetes Company Updates from the Expo Floor

Although many attendees were heard grumbling that "nothing groundbreaking" came out of the annual ADA Conference this weekend, I spent most of my time there darting around the Expo for one-on-one meetings with company execs, and came home with a notebook full of juicy updates on what all the "players" are up to.

(Don't miss the Dexcom and Insulet updates! Spoiler alert: new & improved versions are being actively evaluated by FDA now)

Starting with the smaller players, here's what I learned:

VALERITAS

This company's super-simple patch pump, the Valeritas V-Go, is undergoing a small initial launch on the East Coast. Aimed at type 2 diabetics, the pump replaces daily injections with a once-a-day disposable pump that can be set to give doses in 20, 30, or 40 unit increments. So far, it's covered by Medicare part D and they're working on other health plans.

We like the form factor of this pump, but having a hard time imagining the big benefit to someone who only takes, say, four or fewer injections a day. Having to prefill and insert this pump every single day seems fussier than just taking out your insulin pen for a poke a few times a day...? We're just sayin'...

DANA DIABECARE

This company always has a large, colorful booth at ADA even though they're virtually unknown in the U.S. This year, they were showcasing their Dana pump with iPhone controller. Yes, it's an actual iPhone app that controls the pump! It looks very cool, but isn't anywhere close to getting approved in the U.S. If I got them right, they haven't even submitted for FDA approval since the agency is clearly blockading the notion of controlling an active medical device from a smartphone (some day our prince will come!)

We're told this company is very successful across Asia, China, Indonesia, Polland, Sweden, and in New Zealand — where they're proud to boast 50% of the pump market (which made me giggle — how big could that be anyway?)

DEXCOM

The Gen4 Dexcom is sleeker, faster, able to scale tall buildings! OK, so that last bit refers to an expanded connectivity range of up to 20 feet, which is super-important for users like me who keep wandering out of range unwittingly. Grrr.

The new version will have a more accurate sensor and a brand new receiver that looks suspiciously like an iPod nano dipped in tar, as it is black all over, little scroll wheel and all.

Dexcom Gen4 is being evaluated at FDA now, and the company hopes to gain approval by the end of March (!)

New software is also being developed to make getting your data out and using/viewing it a better experience.

VP of Science and Technology Tom Peyser tells us a new study was just released, comparing the Dexcom Gen4 to Medtronic's new Enlite sensor, also not yet FDA approved. The study, led by by Dr. Steven Russell, showed favorable results (details coming soon) for the Dexcom Gen4.

I also got a quick glimpse of the Dexcom Gen 5, which they're already working on! Whaddya think this one looks like? Yup, can you say iPhone?

side note: once again, Dexcom hit it out of the park by hosting the rockingest party at ADA! Which isn't just a party, they like to emphasize: it's also a fundraiser for ADA

INSULET

Insulet was showing off its new, smaller Eros pod (awaiting FDA approval), which is 1/3 smaller and 25% lighter than the current pod.

"It's all about smaller, that is our story," says Peter Devlin, the company's head of commercial marketing.

But the new pod, when it comes out, will also be introduced with a whole new PDM model, which uses a new communication frequency. The form factor looks just like the current PDM, except that it is jet-black instead of blue. (What's up with this back-to-black trend? I thought we knew that patients like colors...?)

The other big change in the new PDM is a revamped IOB (insulin on board) function, that will now indicate meal bolus insulin still in your system instead of just showing corrections. As a long-time Omnipod fan and user myself, I say: hallelujah! The "mystery IOB function" has always been the one thing I didn't much like about this system.

Insulet is currently testing the new pod in seven Artificial Pancreas study sites around the world. Devlin tells me they are collecting patient data using something called the iDex, a combo of OmniPod and Dexcom (!). Focus of the research is "primary drivers in the algorithm" — aka trying to figure out the best way to control a combo system.

I asked them: what about a pod or other single-site device with a double cannula for glucose monitoring and insulin delivery? "We're working on it," is all Devlin w(c)ould say.

MEDTRONIC

The company has just submitted their new and improved, smaller Enlite CGM sensor to FDA, so it's now being evaluated together with the Medtronic Veo, the advanced pumping system available in Europe that offers the low-glucose suspend (LGS) feature. LGS is potentially life-saving technology that can shut off insulin delivery automatically for two hours if the CGM detects a hypoglycemic event and the user doesn't respond to alarms.

The new Enlite sensor has "accuracy benefits," has only a 5-7 minute lag time over fingerstick tests, and the "insertion volume is 69% smaller," they tell me. Medtronic is hoping for a decision from the FDA within 12-18 months.

Concern on the part of FDA is two-fold, apparently:

They're worried about false claims that the Enlite sensor "cures hypoglycemia" — Medtronic has to be careful with their language so that patients won't hear the implied claim, "I won't get hypo using this pump."

"But people are already low when it shuts off, so it doesn't prevent hypos," noted Greg Meehan, VP and GM of the company's CGM business.

They're concerned about sensor accuracy that might make the automatic shut-off kick in unnecessarily.

"It gives you so many pre-alarms as you're starting to go low that it's impossible to ignore," Meehan says. "And there's a REALLY LOUD siren when it actually turns off. No way you are going to miss that!"

On the Artificial Pancreas front, Medtronic's big news is the dual sensing technology it is testing. It's pairing its current CGM sensor with optical sensor technology that came from its 2009 acquisition of PreciSence to improve reliability for use in a closed-loop system.

This alternative sensor is based on optical technology, as described in a recent report by ASweetLife.org: "It is injected into the upper layer of the skin and measures the amount of glucose binding to fluorescent receptors within the sensor. When glucose binds to the receptors, the receptors give off light that can be measured, quantified, and reported back in terms of glucose concentration. This optical means of quantifying glucose levels in the tissue would act as a second check for the existing sensor, and the two together could be read and correlated by the closed loop system to ensure accurate glucose inputs were being used by downstream algorithms."

The optical sensor system is still under development, but has already been tested in pigs and humans.

"We spent the last few years 'productizing' it. The chemistry is on the tip of the optical sensor. The optical sensor will continue to work even if the cannula of the first sensor is pulled out," says Rajiv Shah, senior engineering director at Medtronic.

Shah tells me the company needs about three years to move the product forward so it can be commercialized. Some may be skeptical that this sensing technology is viable at all.

"25 years ago I was told subcutaneous (current) sensing would never work," Shah says with a smile.

Meanwhile, algorithms are being developed to better understand the lag time, be able to deal with delays, understand system flaws and even consider individual medical history, which can be programmed in.

"Whatever algorithms do, they have to ensure safety," Shah says.

Finally, of course I had to ask Medtronic: why didn't they make their new MySentry CGM remote monitor compatible with their own stand-alone CGM product, the Guardian? It just seems crazy... There are several business reasons, apparently.

"MySentry started as research product... it was not intended to pair with the Guardian. We started work on it a number of years ago, and by the time we had the opportunity, we even wondered, should we launch it, or just wait to move to the next generation?" Meehan says. "We didn't expect to get FDA approval."

The company says they don't actually sell a very big volume of Guardian products on their own. Rather, most are sold as part of the integrated system with the Revel pump. They talked about a "short lifespan of the product" as they move to newer models. There will be no Guardian 2, they stated clearly.

"It's true: we've underserved the stand-alone CGM market. Our focus has been on the integrated system," Meehan admits.

Finally, I asked them about the recent spat with Regence Health in the Pacific Northwest. Apparently, a nasty fight over pricing levels caused Medtronic to break off relations with that insurance provider, leaving patients ostensibly in the lurch.

"We're referring patients to local distributors who can get them their pump supplies. No patients will be left out in the cold," says director of PR Amanda Sheldon. Maybe not, but that's got to be a pain, having to shift all your prescriptions and order history over to yet another layered organization, get your doctor in touch with them for prior authorization, etc., etc. It seems like it's always the patients left holding the bag when these things occur!

SANOFI

Physicians were lining up to see the big show about the new iBGStar meter that connects directly to an iPhone or iPod touch. I imagine it's an even bigger wow factor for doctors to see a glucose testing device — something historically considered part of their clinical turf — plugging into a mobile phone. What? You mean my patient might be yapping to her best friend, or playing Angry Birds while testing? No worries, docs, we already do 15 other things while testing anyway. Am I right, PWDs?

Since cell phones and consumer devices change so fast, the question came up about product lifecycle. What happens when newer versions of Apple products render the iBGStar outdated? "We expect a 15-month lifecycle on this product," said Dennis Urbaniak, VP of U.S. Diabetes at Sanofi. I guess that means lots of upgrading required for users.

In the realm of "advancing the scientific dialogue," Sanofi submitted no less than 150 research abstracts to this year's ADA, Urbaniak says. "And we're also working on a number of projects outside the convention center, for communities."

They actually did something really neat! On the Tuesday before the convention began (bringing over 16,000 visitors into town), the American Diabetes Association hosted a "Diabetes Day," supported by Sanofi U.S., for hospitality workers across the city, complete with a free FIT Clinic at Thomas Jefferson University, cooking class, diabetes education, and CDEs on hand to answer questions. The major of Philadelphia even made a proclamation in thanks. After all, the conference relied on about 51,000 hotel rooms (nights) over the course of the 5-day ADA Conference, I am told. That's a lot of cleaning, washing towels, and room service! The ADA plans to create an annual tradition of Diabetes Day programs for hospitality workers in the cities hosting Scientific Sessions each year.

Sanofi also supports the related Cities for Life program launched April 24 in Birminham, AL, which is a grassroots, community-based diabetes management program led by the American Academy of Family Physicians (AAFP). The program works with community groups to "create an environment that facilitates healthy lifestyles and diabetes management," and they'll be working with local "Patient Navigators" to help take it to other communities, Urbaniak says.

Sanofi is also a major supporter of the new Dribble to Stop Diabetes campaign — a very cool high-profile national multimedia campaign designed to encourage basketball fans to live an active, healthy lifestyle and raise D-awareness. The program was developed by The National Basketball Association (NBA), the Women's National Basketball Association (WNBA) and the NBA Development League, in collaboration with the American Diabetes Association.

"We want to be a total diabetes company and we need to show we're serious about it," Urbaniak says.

One more part of "embracing the whole patient experience" is Sanofi's new website called "The DX," which culls a variety of information and articles about living with diabetes — working closely with a number of our fellow diabetes bloggers in the patient community.

They're adamant that it's not a promotional channel for the company, but rather "a way to promote good content about life with diabetes."

What about FDA regulation on social media? Weell.... the FDA is ridiculously overdue on issuing firm guidelines for Pharma companies, which can and have sometimes nevertheless been penalized by the agency for inappropriate use of social media channels.

"They may never (issue clear guidelines). Our approach has been if we do the right things with our approach today, we're not going to get in trouble later," Urbaniak says. His colleagues cite how a number of Pharma companies were compelled to shut down their Facebook pages after a ruling that the pages had to be open for comments.

Right... that would be the S word in social media.

And that's all for this round of updates, Folks.

Disclaimer: Content created by the Diabetes Mine team. For more details click here.

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ANNOUNCING: Our 2012 D-Moment Holiday Sweepstakes Winners!

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ANNOUNCING: Our 2012 D-Moment Holiday Sweepstakes Winners!

The results are in for our 2012 DiabetesMine D-Moment Holiday Sweepstakes!

We asked PWDs everywhere to share, in a few sentences, their big "aha!" diabetes moment of 2012, as in:

What struck you hardest this year, in that you learned or observed something new?

The idea being that whether you've had diabetes for two months or 20 years, there always seems to be an "aha moment" to be had.

The contest ran from Dec. 3 through Dec. 20, and we received more than 50 entries from many segments of the Diabetes Community, including quite a number of type 2s (welcome!!).

Entries ranged from big "epiphany" moments of being diagnosed to "little victories" such as finding small ways to eat healthier or better communicate with doctors. While the responses ran the gamut of how people are living with diabetes, many reflected a similar theme of taking charge of their own health and discovering new patterns in their own D-management challenges. We love the running theme of EMPOWERMENT, and hope that is what 2012 was all about for many of you.

A few entries that caught our eye especially:

"I had a lot of 'Aha!' moments with diabetes this year, but the biggest is that I finally saw patterns forming in my day-to-day experiences that led me to recommend my own basal insulin changes to my doctor. I felt like I finally had influence over my health." - Rachel Kerstetter

"I'm a new T1 as of August, I'm 33 and a marathon runner. My biggest revelation is the shocking fact that most people have no idea what diabetes is or the difference between T1 and T2. It's shocking. I just remind myself of that, when someone tells me to 'exercise more.' - Corey Melke

"Our daughter was diagnosed March 19, 2011- two weeks before her 4th birthday. I sob when I see her pre-diabetes photos. Diabetes sucks! However, to provide the best care, I must find peace with diabetes and appreciate what it teaches us -- patience, awareness, strength, perseverance and selflessness." - Alison Schmidt

And this one, which was short of a shocker, given that it sounds like the doctor is taking the liberty of using the "carrot and stick" method on this poor PWD:

"My life as a type 1 diabetic started later than most being diagnosed at 19. Upon my diagnosis, about 7 years ago, my doctor signed me up to get a pump and CGMS very quickly. This past spring I decided that checking my blood sugar was no longer important. When my doctor found this out she took away my prescription for pump supplies and made me go back to needles and vials. Talk about an eye opener! There is no way to manage your blood sugars without checking when giving yourself insulin the old fashion way. I was only without my pump for 2 months, but it was one of the hardest times in my life. I took a lot from this, including to always 'test, don't guess.' I saw that sometimes when I thought my numbers were perfect they were far from it. I have been blessed with the opportunity to use the pump for better control, and I now know I do not want to treat my diabetes in any other way!" - Kim Wilborn

And now ... on to our winners. We wish we could give everyone a prize! But remember, this was a raffle, so using Random.org, here are the lucky NINE winners selected to receive prizes:

$75 Walgreens gift cards go to:

1. Andrew Bell: "I learned that yoga is changing my life. It is life. So I've become a certified yoga teacher. Yoga means union, and union is most important."

2. Melissa Thielen: "I learned that technology isn't everything when it comes to my diabetes. Having upgraded to both the t:slim and Dexcom G4 was exciting, but that excitement wore off and I realized that what matters most is the management of the diabetes, not necessarily the technology to do it with."

3. Aliza Chana Zaleon: "I've learned how the diabetes community can amazingly come together to support one another during the difficult times, and during the good times, with emotional support, supplies, and whatever else may be necessary. We are truly a family!!"

$50 gift certificates for Skidaddle diabetes bags go to:

4. "BooBooBear": "My 'Aha' moment came after the second time this year I was stopped by the police for suspected drunk driving and I was actually having a low blood sugar incident. It was scary and totally embarrassing. I will never get behind the steering wheel without checking my glucose levels again."

5. Rita Meadows: "My daughter is 11 years old and has type 1 diabetes. Over the past 3 months during one week per month, her blood sugars go on a roller coaster ride. On the third month, we thought, 'Aha! Puberty!'

6. Steven Grossen: "I just turned 16 on March 22, 2012, and a month later I was diagnosed with type 1. It was really hard for me. Sometimes, I feel depressed but I realize that I have a good family to help me. It's hard because my dad lost his job and my mom works, but she don't make much. I just want my family to have a great Xmas."

And sample boxes of LEVEL Life Glucose Gels with yummy new flavors go to:

7. Jasmine Cloud (currently living in Italy): "After countless visits to various offices trying to get into the Italian health care system -- and free diabetes supplies -- I've become disheartened at the amount of time, stress, and energy these visits have taken. But then I had my Aha moment: my health is worth it."

8. Carly Thompson: "My biggest day of 2012 was my wedding day. There was so much to plan, some D-related (like a wedding day basal program, 'Wasal,' and hiding glucose tabs in my bouquet). The kicker was hearing my Omnipod fail mid-ceremony...I smiled as my husband shook his head, recognizing the sound instantly."

9. Mom and Daughter combo, Carol and Casey Byrd:

"I'm sending this on behalf of my 9-year-old type 1 daughter, Casey, who says: 'This year diabetes has been discouraging me. I forgot I had diabetes and volunteered for a s'more eating contest. My skin looks different from my sister's because I have sensor insertion scars on my bottom. I can't drink pop at school for a class prize."

We want to thank EVERYONE for sending in your D-Moments. All of them are winning lessons and discoveries, and it's great to reflect at the end of the year, no? We are right there with you in holding up these moments as experiences that shape who we are.

To summarize our sentiments, these two caught our eye:

"In 2012, I learned that it's not always my fault if my diabetes gets out of control, like if my insulin is bad or something. All I can do is my best." - Leanne Ortbals

And from D-Mom Alexis Newell, who created the advocacy group the Blue Heel Society:

"Diabetes is here to stay. It's not leaving anytime soon. The faster I learn to accept that, the faster I will be happy and be able to enjoy each day of our 'new normal.' Everyday is a blessing, diabetes or not. And some days, diabetes brings us blessings too!"

Exactly! All we can do is our best, and perfect shouldn't be the goal — just being better is enough to help us appreciate the lives we have!

Congrats to our winners, and thanks again for playing.

Disclaimer: Content created by the Diabetes Mine team. For more details click here.

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