Diabetes Mine - the all things diabetes blog

JDRF on Diabetes Design

Who's excited about our new YouTube-based Diabetes Design Challenge, launched yesterday?  Ooh, me, me!  And guess who else?  The national advocacy group JDRF (Juvenile Diabetes Research Foundation).  I was delighted to have a talk earlier this week with two heads of their progressive Artificial Pancreas Project: research director Aaron Kowalski (interviewed here before) and head of new technology Cynthia Rice.  Here's a synopsis of what they had to say, mostly in Aaron's words:

 

GOLDEN  OPPORTUNITY

When you think about medical devices, they're most really driven by physicians -- pacemakers, etc.  These are physician-driven tools.  However, diabetes is so unique in that you see your doctor every three months or so -- if you're diligent -- and you manage everything the rest of the time.  You own the devices, you're managing them, and you just go in for tune-ups.

Diabetes provides unique opportunities to take these devices and ratchet up their form factor.  We think you hit the nail on the head when brought this issue to the forefront.  We need smaller, easier, more convenient devices, and we've only begun to see these materialize. It’s a golden opportunity.

LIFE POTENTIAL

When we talk about the artificial pancreas, we believe it has the potential to transform life with diabetes. Of course the  safety and efficacy have to be there, but we can do that. We'll show that in the coming years.  In fact, the Artificial Pancreas (AP) problem was actually solved in 1970s, with the BioStator machine -- but that thing is the size of a large chest fridge-freezer, so it works, but you can’t lug that around.

When we talk to volunteers about new devices and the AP, they're motivated by things like their 8-year-old granddaughter who was diagnosed recently, saying it's so hard for her to dress -- she needs to get a seamstress to make a special pump pocket in her pants.  These are the life issues people are dealing with.

Pumps and sensors are now very good. They're helping people.  But to really make as wide an impact as possible, you have to concentrate on the form factor, ease of use, and incorporation into other devices (like cell phones).  That is huge.

If the majority of people with diabetes can’t easily benefit, then we haven’t reached our goal.  We're hearing from many, many people all across the country, saying this is a critical issue -- for toddlers, older patients, people of all ages and walks of life.

THE BALANCING ACT

Our job is to help people do better -- get better A1C results, be happier, experience less hypoglycemia, and achieve peace of mind. 

If you think about it, these are the two key goals:
1) glucose control
2) peace of mind/ happiness

You have to have both.  It's a difficult balancing act. You can go too hard on blood glucose control and be miserable, or you can go the opposite and be happy-go-lucky but very unhealthy.

If we’re going to impact people positively, then we need to help them with their blood glucose control -- to experience fewer swings -- but also make it EASIER for them to accomplish.  That means issues like not having to lug around so much stuff, not having to think about your BG levels every second of the day, or count every speck of carbohydrate you eat.  We talk about good diabetes management from the medical side, but the other side of the equation so important too…

GIVE US CHOICES

People with diabetes are so varied.  There's the 8-year-old kid going to school every day, versus the older gentleman who may be retired and barely gets out of his house.  Consumer design takes that variability into account, but traditionally medical design does not.  What we really need and want are choices.

Someone who travels a lot might like a meter integrated into their cell phone, whereas parents seem to typically want small products that fit in their or their childrens' pockets.  Some people want a separate handheld controller, while others don’t. Some don't mind being "tethered," while others can't stand it.  This is one of the key things we've learned in our initiative.  Academic researchers have now done many clinical experiments on AP technology.  The next phase is to push companies to get on board, especially with creative designs.   

One of our core beliefs is the importance of having more than one company working on this in order to stimulate competition and provide a variety of choices.  We applaud what you're doing at DiabetesMine, because it sheds light on this need.

You have to love the folks at JDRF (and not just because they said nice stuff about the blog); they really "get it."  So send them some love.  Then send us your contest entries. Oh yes.

The 2nd Annual DiabetesMine™ Design Challenge

A very big announcement today, my Friends.  Welcome to the kickoff of the ...

2nd Annual DiabetesMine™ Design Challenge

* a competition designed to foster innovation in diabetes design and encourage creative new tools that will improve life with diabetes *

Two of the most enticing design concepts will win a package of prizes to help further their creative efforts: $1,000 in cash, some pro-bono professional advice from world-renowned design experts, and free access to the next Health 2.0 conference for one adult winner.

This contest is co-hosted by my friends over at MedGadget, the Internet journal of emerging medical technologies, and supported by the world-renowned design firm IDEO, with headquarters in Palo Alto, CA.  The campaign is generously sponsored by Cory and Justin Oringer, two young brothers (ages 14 and 11, respectively) who have both been living with Type 1 diabetes for more than 10 years each and have already seen and personally experienced many wonderful benefits of design innovation in diabetes technology.  Just a few of the innovations that have changed their lives include:

• blood glucose tests that previously took 30 seconds now take only 5 seconds
• 5 microliter droplets of blood required have now shrunk to just .3 microliters
• where we once there was finger sticking only, we can now use alternate sites (nighttime toe testing gives the boys' fingers some healing relief)
• multiple injections have now given way to the option for pumping with convenient temp basals, correction calculators, and "bolus wizards"
• 21g lancets have slimmed down to just 30g needles, now available in "virtually painless" lancing devices like Renew and Pelikan
• These devices provide the lancet needles in cartridge form, doing away with accidental needle sticks (Cory's schoolmate once poked himself with a lost lancet, creating havoc at their school)

At the same time, Cory and Justin have witnessed (and lived) the revolution in communication we fondly know as Social Media.  Who ever heard of a "blog" back when they were diagnosed?  User-generated content has changed lives, and driven a whole new wave of excitement about contests and challenges (think American Idol, Dancing with the Stars, Survivor, and The Apprentice).

"With a father deeply entrenched in the diabetes business, Cory and Justin inevitably wind up in the midst of numerous innovation-brainstorming conversations.  They’re very excited to be involved in the DiabetesMine Design Challenge," the family writes to me. 

Now for the particulars:

THE BACKGROUND

It was just about this time last year that I posted my Open Letter to Steve Jobs, calling for the gods of consumer design to help revolutionize design of diabetes devices.   This spurred a ton of conversation across the blogosphere and mainstream media.  In the weeks and months that followed, all sorts of individuals and organizations came forward with many compelling new prototypes, designs, and ideas.

This year, we're making it an official competition, laying down the gauntlet, as it were, to anyone passionate about diabetes and product design. Whether you're a pharma R&D pro, an independent engineer, a design student or an enterprising patient, we want to hear from you.

ELIGIBILITY

This competition is open to all individuals and organizations developing devices or supplies for people with diabetes (medications not included), or enterprising patients with unique prototype concepts. DiabetesMine™ will accept submissions in two categories: under age 18, and age 18 and older.

CONTEST TIMELINE

Submissions can be made beginning April 30, 2008, until Monday, May 26st, 2008, at 11:59 pm PST. The winners will be announced on Friday, May 30th, 2008.

PRIZES

The winners will receive a combination of rewards intended to help take their ground-breaking diabetes design concept to the next level: prize money, consulting advice, industry event exposure and media coverage. 

• Sponsors Cory and Justin Oringer generously offer $1,000 each in two entry categories: under age 18 and over age 18 (total prize money $2,000).

• Health and wellness consultants from world-renown design firm IDEO will host a two-hour workshop to help each winner refine their concept.

• Organizers of the “innovation incubator” Health 2.0 Conference have generously offered one free access ticket to their Fall conference in San Francisco, October 21-23rd, 2008, for the winner of the adult competition.

• MedGadget and DiabetesMine™ will promote the winners through articles and blogs, and possibly also feature some of the coolest finalists.

COMPETITION GUIDELINES

• All entries must be in the form of a movie or an animation, no more than 2 minutes long (all content in English), which will be submitted by uploading into the DiabetesMine™ channel on YouTube.

• Each product or design concept must be new, i.e. introduced within the last half-year, or in development phase, possibly undergoing user testing now.

• One video per product idea only, please.

• The product or design concept needs to have been created in its entirety by the submitting team, i.e. it must not infringe or violate the rights of any third parties, including, but not limited to the copyrights, patents, trademarks, trade secrets, and right of publicity/privacy.

• Each video submission needs to contain your brief but complete "Elevator Pitch," covering the following aspects describing your new design:
  
  • Explanation of the everyday problem(s) your concept is designed to solve – how does it help improve life for people with diabetes?
  • Description of the medical application of the product. 
  • Detailed depiction of the product's look and feel, material, and dimensions.  Ideally the video will include a 360-degree shot of the product or design concept.
  • Demonstration of the product in action and its various functions, if possible.
  • Each video segment must display the 2nd Annual DiabetesMine™ Design Challenge screen at the beginning and end for five seconds. (See instructions below on where to download that slide)

[for some inspiration, see tips on crafting your Elevator Pitch here.  View the sample contest entry videos here.  Or browse the various product pitches here.]

HOW TO SUBMIT YOUR ENTRY

1. Create your video, and add the DiabetesMine™ Design Challenge screen (downloadable HERE) to appear at the beginning and end for five seconds.

2. Give your video a short, recognizable title (ideally the product name), to make it easy for readers to vote on favorites.

3. Go to this site: http://youtube.com/group/DiabetesMineDesignIT, and click on “add a video” to upload.

4. Post a comment on this blog below providing the following information to help identify your video:

• Video title
• Your name and age (category you are entering)
• Valid email contact info
• State of residence
• Your status (medical professional, start-up company, independent designer, student, etc.)

5.  Note that by submitting an entry for the 2nd Annual DiabetesMine™ Design Challenge, submitters agree to these additional OFFICIAL CONTEST RULES.

THE JUDGING CRITERIA

Winners will be evaluated by both popular vote and by a panel of three judges.  In a sort of reverse American Idol system, reader voting will be taken into consideration, but the final determination will be made by the judges.

The judging panel will consist of one MD/Editor from MedGadget, one design expert from IDEO, and Amy Tenderich of DiabetesMine™ providing the patient perspective on user experience/desirability of the product. Entries will be judged on three-pronged criteria:

• Efficiency - how does it solve a real-life problem for people living with diabetes?
• Clinical Efficacy – how realistic and applicable is this product from a medical standpoint?
• Aesthetics - it's the look and feel, Baby!  How good is the pure design?

Remember, good design can be applied to anything, even something as "low-tech" as a special container for disposing of used glucose test strips.  Let the innovation begin!

Gentle Pelikan: My Finger Health Challenge Results

OK, so the month of April is coming to a close and it's time for a close inspection of my so-oft-tested fingertips. If you'll recall, I began evaluating the ground-breaking new Pelikan Sun electronic lancing device on April 1 and promised to make a month of it.

Let's start where all good reviews should begin, by explaining the methodology: in this case, utterly unscientific.  I simply vowed to use the Pelikan only on my right hand for a month, while continuing to use my regular spring-loaded lancet on the left.  Of course there was no exact 1:1 ratio on the number of times I tested each hand, but I can tell you that I preferred to use the Pelikan when I was at home, while mostly using the older model while I was out and about, so that hopefully leveled the playing field somewhat.

The Usability/ Experience

So what did it feel like?  Did I run into problems?  Was it convenient to use, or a pain in the @#$% (not finger)?

For me, this product gets a 9 out of 10 on the "feel good" scale.  I've never enjoyed (or least disliked) taking my glucose readings than I did having a gadget that keeps you from feeling anything at all. In fact, all I noticed was a quick "brushing" sensation on my fingertip.

Just as with so many other new-fangled diabetes gadgets these days, I did run into some technical difficulties.  The first unit I had (which comes in nice, minimal packaging, btw) continually gave me error messages, causing me to waste almost a whole cartridge of lancet needles.  But the company was super-responsive and replaced that first "lemon" with a fully functional unit right away.

The Pelikan couldn't be easier to use (unlike the MultiClix, for example, which I sometimes found difficult to advance). It only has three buttons, and two of them are just the up-and-down arrows to adjust lancing depth.  I found that I did have to increase the depth a bit over time to get it right -- if you don't draw blood, you've wasted a notch on your cartridge (once it's advanced, there's no going back).

I'm up to 1.3 on the depth scale, yet my fingers are happy.  I'm not posting hand photos again because those little black dots have faded on BOTH hands, probably due to more careful lancing on the sides of fingers, rather than on the "pads."  But the fingers on my right hand (Pelikan hand) do feel softer and less calloused, no doubt.

The Pelikan is sometimes inconvenient to carry, because of its size, but it's kind of addictive: the more you use it, the more you want to (see below).

The Usefulness/ Efficacy

So did the Pelikan perform it's medical function well?  Well enough to warrant the inconvenience and the cost?

I found that I was excited about using it, and still am after a month of obligatory use.  In fact, I feel very disappointed anytime I'm in a place where I don't have access to it, and have to use my old "thumbtack" lancet instead.  So I test more often, and with more enthusiasm -- which I firmly believe is good for my diabetes care (despite recent headlines).

Yes, it still gives me an occasional error message, but what product doesn't?  There were only a few times when my hands got so cold that I had to do a repeat stick, thereby wasting some notches on the $7.50 cartridge ($15 for a set of two, containing 50 lancets each).

I guess what I'm saying is: this thing works well and is totally worth the money if you 1) really hate the sensation of traditional lancing, or 2) are caring for a child with diabetes.  I can't imagine any kid who wouldn't be jumping for joy over a switch to the Pelikan.

Yes, $200 upfront plus supplies is quite an investment, but think for a moment about how easily that money might be frittered away on something entirely non-essential.  I find that it's true what they say: people tend to spend money on what they want, not what they need.

In the final analysis, here's how I really feel: I'm excited that my Pelikan Challenge Month is over, because now I am finally free to use it on both hands.

 

GlucoDay and the "Semi-Invasive" Dream

Who's ever heard of the GlucoDay® S semi-invasive continuous glucose monitor?   

I didn't think so.  I picked up a hint from a medblogger's footnote. Then I found it described over at DiabetesMall, although the link to the product on the manufacturer's site doesn't seem to be working.

That manufacturer would be A.Menarini Diagnostics, Italy's largest pharmaceutical R&D company, which released the GlucoDay across Europe a year ago (or two? -- I've had no luck getting hold of them despite attempted introductions).  The GlucoDay is apparently the first system in the world based on a "microdialysis” technique to obtain the CE marking for the Medical Device Directive, required to market any product in the European Union.  But don't get too excited; I read the fine print, and it's only designated for clinical use, "worn by the subject for a 48-hour period."

So why am I bringing this up?  Well, I happen to love innovation, and like Kerri, I'm finding the Guardian MiniLink sensor to be rather uncomfortable.  Meanwhile, I didn't like using the DexCom much at all.  I'm feeling ready for something less invasive.  So these guys had me at semi-invasive.  But what the heck does that mean? 

Apparently the only thing going in your body with the GlucoDay is a "microfiber" inserted under the skin, as part of a small "biosensor."

The description is a bit cryptic, but it appears to be a two-part wireless system where the controller unit is sort of Walkman-sized.  Granted, in this day of micro-devices that's not too exciting, but maybe that's the current trade-off for less invasive.  I love the data I was get from the Guardian.  But I don't love that long cannula and the mobility of the sensor that often makes your skin sore.

So I'm thinking, maybe we've all been too ambitious expecting a jump straight from needles & cannulas to the non-invasive dream.  Maybe there's a step in between -- something semi-invasive that will help us with the comfort imperative.  Then again, the data on that last link is at least two years old.  And then I found this neat overview which is, oh... just about 10 YEARS OLD.

*Sigh...*

Ungreen

Without pointing any fingers specifically, I would just like to say that the amount of packaging for most diabetes devices seems unnecessarily wasteful.  So NOT GREEN.  Check out the photo proof below:

My, what a pile.

I realize that a certain amount of cardboard, foam, and bubble wrap is required to ship the stuff without damage, but some of it just seems over the top.  I know that other PWD consumers have noticed this as well.  See Allison's notes on huge boxes for small glucose meters, and Gina's gripe over bulging bottles that hold far too few test strips.

Again, no offense to the company, which makes a wonderful product, but what is up with this fancy hard-cover attaché case that comes with OmniPod starter kit?

Once you take out the pump and its mini carry pack, you never look back at this thing again.

Medtronic's Guardian box is also surprisingly gi-normous, as my kids would say.  We could make a bed for the kitty out of that box. 

Not to mention the layers and layers of foam inserts.

 

Our garbage collectors must think we're running a private hospice over here, with all this medical waste going out.  In fact, I cringe to think what heaps of extraneous packaging materials must be flowing through actual hospitals these days.  Hasn't the push for eco-friendly packaging been going on for at least five years?  For an entire hospital, it's certainly not easy being green.  But for the stuff you ship out to individual diabetics across the country, could you maybe scale it down just a bit? 

 

Mobile Health Stuff, Available Now

Future visions of mobile health tools are all very well and good, but what about RIGHT NOW?  A couple of new gadgets/services you might like to know about:

* As of mid-March, consumer health information news agency MedTrackAlert is syndicating its health content to mobile phone users across the country via 4INFO, the leading text messaging service in the United States.  This means that at least two million mobile phone users now have touch-button access to MedTrackAlert’s health info from anywhere, anytime.  Are you a cellular addict?  The type who actually likes to read everything -- even news headlines -- via your Treo, Blackberry, or Razr?  Here's the link to subscribe.  It's free and extremely easy to set up. I'm trying it out myself now, although I prefer to actually sit in front of my oversized LCD screen to read the news.  How old-fashioned of me!

* How about a USB memory stick that not only stores your BG data, but also helps provide a "second opinion" on your current diabetes treatment?  A certain Dr. Michael Albisser in Florida is experimenting with just such a device, called MyDiaBase. 

In his own words: "The device is a full featured SMBG database and personal diabetes registry, all in a portable memory module.  Not just a mini EMR, it includes software with unique features that realize a 'personal diabetes prescription check.  This RxChecker accesses the MyDiaBase and then can support the user in obtaining an objective '2nd Opinion' of their current diabetes treatment.  The 2nd Opinion teaches the user when to contact their doctor and what to talk about.  This closes the circle of care rather effectively."

The University of Miami has completed studies and has published results or submitted them for publication in medical journals.  They've also purchased a bulk quantity for the use of their patients in the clinical group at the Diabetes Research Institute (DRI).

The product is currently classified as educational and available for free market purchase both to health care providers and directly to patients.  Providers get it at a discount, and can then sell it to their patients at a price that covers user instructions, for about $100, or less.  Any early adopter types here willing to buy one and give it a try?

* Don't forget GlucoMON.  Provider DiabeTech's CEO Kevin McMahon reminded me recently that theirs was the first-ever wireless diabetes management system, introduced back in 2003.  He's been after me to review the system for a while, but somehow it just never got onto my personal docket.  Besides, veteran D-writer David Mendosa has already done a bang-up job.  To paraphrase:

GlucoMON is "an automated, long-range wireless blood glucose data monitoring and transmittal system."  It requires no computer, Internet connection, or phone line.  Rather, it currently it works with LifeScan's OneTouch Ultra (deals with other meter providers under negotiation).  All you do is plug the OneTouch meter in to the GlucoMON unit, and then plug that unit in to an electrical outlet, and whala! Your data can be transferred over the Diabetech network and stored by their GlucoDYNAMIX server software in a secure patient record application.  The data -- including patient profile, patient-specific rules, alerts, reminders, reports, and education -- can be streamed and shared in real-time with your doctor, educator, or parent, for children with Type 1. 

Pretty cool stuff. And you can get it now without a prescription, for a monthly service fee of $29.95.

"Think of us as a wireless phone company that just does diabetes," Kevin asserts.  As we all know, there's something to be said for being a one-trick pony -- 'cause who understands diabetes better than the people who live it and breathe constantly it like we do?

Qualcomm's Mobile Health Vision: "Personal Health Phones" and More

Wireless technology leader Qualcomm Inc. has some very big ideas about untethered devices for healthcare, and in particular, about using your mobile phone as a health aid.  I was lucky enough last week to get a "back stage pass" for a chat with Don Jones, the company's VP of Business Development, who's considered a visionary on the application of wireless technology to the healthcare and medical device sectors.

DM) Don, in just a few sentences, how do you define “wireless healthcare”?

We choose to define it as wireless health -- not healthcare -- because this includes fitness, wellness, and consumer health.  It's basically anywhere that connectivity can be applied to people's health.

Qualcomm is a B2B (enterprise to enterprise) organization, helping companies deliver wireless health services by developing the enabling technologies.  We've focused on small computing devices that have connectivity and incorporate into people’s lives beyond traditional voice services.

DM) Can you give us some examples?

Wireless pills, for example, are pills with integrated circuits. They're best-known as Given Imaging Pills for looking at the digestive system. You swallow this camera pill and the data is wirelessly received on a recorder. It then passes through your system.  Other pills are dissolved in the stomach like regular pills, but before they do, a communication mechanism tells the provider that the medicine has arrived.

Another example is a so-called wireless band aid, or “smart band-aid.”  This is a transdermal detector that can check your vital signs and even your blood pressure without a cuff.  It's peel-and-stick, disposable.  This has been used for example to keep tabs on mental health patients taking psychotropic drugs.

Other wireless medical devices might help your Grandma, who's on blood thinner, and had several strokes.  Previously, she had to go in to the doctor regularly for adjustments, at first twice a day for up to three months, and then once a week, and then monthly for life.  That's a big burden for her.  Now this monitoring can be done at home without the time and trouble of going to the doctor. Networked devices are able to report actionable information to her provider.

DM) What will be the biggest impact for people with diabetes?

As you know, diabetes device manufacturers are all turning to wireless connectivity for pumps and monitors. I think we'll see incremental improvements -- more meters that interface with cell phones and have glucose diary functions like the t+ Medical LifeScan meter with wireless connectivity recently introduced in Europe. We've also partnered with HealthPia here in America on the GlucoPhone.

I think going forward, three models will evolve:

1) The 'anywhere-anytime' connected glucose meter -- meters that can communicate wirelessly with an insulin pump or phone. Initially this will be based on Bluetooth technology, although not for the long-term; it's a poor solution as the pairing issues are too difficult and it tends to be 'power-hungry' -- whereas meters now last a long time on coin-cell batteries. 

We're working to solve those problems: easy pairing, power management, identifying YOUR device versus other devices, security issues, etc. There are new radio systems on the horizon that look very powerful, but probably won't be commercially available till 2010.

[We're also working on Body Area Network technologies -- devices implanted inside the body, like pacemakers but with wireless connectivity, that can be used for a variety of health conditions.]

2) The meter and phone will converge. The current GlucoPhone is a kind of 'sled' that the meter slides on. In the 2010 timeframe, we'll have meter-phones that are more truly integrated devices.

3) Meters that connect everywhere. Eventually all meters will have cellular radio chips inside, and will be able to interface with web-based systems, back-end systems, and be connected via Wifi to report data back to a PC.  This is different from No. 1 because it doesn't require voice (phone) functionality at all.  This system may employ reminders, remote coaching, sharing information with caregivers, and the like.

DM) There’s always the issue of who’s paying doctors to analyze all this data they receive wirelessly. How can the technology help us if the healthcare system isn’t set up to support it?

What we’re observing is the formation of 'data intermediaries' that manage it, package it, and flag important and actionable events.  In other words, a whole niche of new service companies is being built up around this need.

Wireless CardioNet, for example, is an anywhere, anytime, device for electrocardiograms.  Patients install it themselves at home, and wear it for 14 days, using a PDA device (that reaches up to 200 feet).  The Cardiac Monitoring Center is the intermediary. Each doctor chooses how to receive the information, and what they want to be notified about.

Also, look at what Philips is doing.  Historically they were a consumer electronics "box company." They started buying services companies like LifeLine -- the "I'm falling and I can’t get up" people.  Then they bought Visicu, which provides critical care specialists with 24/7 remote monitoring of numerous ICU beds in hospitals. They also bought Emergin, which provides medical alarm signals throughout hospitals.  And they launched the Motiva set-top TV box for remote chronic disease management.  So they're building up their profile as a medical services provider.

Reimbursement is still an issue to be worked out.  As long as the healthcare ROI (return on investment) can be demonstrated, insurers may be pressured to move faster, especially in areas like diabetes.

DM) So are these wireless healthcare monitoring devices mainly for the elderly and homebound? Or will they become "mainstream"?

Certainly it's useful for everyone, no matter what state of "healthy."  One Qualcomm project that will be marketed directly to consumers is called LifeComm.  We're working with cell phone manufacturers to design 'Health Phones' – that work like normal cell phones, but also have a condition-related set of management tools on the phone as well. Those can be medication reminders, personal emergency response services, coaching services, fitness or weight management tools, diabetes management or many more.  The phones essentially act like 'personal health managers.'

These will be brand new custom phones, kind of Blackberry like, the first of which should launch in late 2009, early 2010. If you think about it, the Blackberry did four things:

• Introduced a custom device with a really good user interface
• Offered new software on those devices
• Set up new server software on the back end to support the system, and
• Provided unique service – they managed to strike deals with Fortune 500 companies to service them internally, behind the firewalls

We’re doing all this and interfacing to live services for specific conditions, disease management, and overall health promotion.   

Early design health conscious phone -- not from Qualcomm

DM) So are health phones the Next Big Thing?  And what about cost?

Consumers just want to know if something is more convenient or if it helps improve their life.  We've done a ton of research -- focus groups around the country on storyboards to prototypes -- to understand how wireless connectivity be used to change people’s lives in a way that they think is valuable.

For diabetes, research suggests that an integrated meter in a phone is far more appealing to Type 2’s than Type 1’s -- because the Type 2's test less often, and don’t always carry their meter.  With the phone, they'd always have it on-hand.  They're also more interested in the coaching and convenience of the services.

We think large employers will eventually be willing to subsidize a portion of these phones, that act as health aids.  We foresee a day where Flexible Spending and health savings account dollars can be used for a cell phone if it's a health phone.

You choose the phone you buy because it has certain functionality. So we also believe that consumers will be willing to pay a reasonable pricing premium for a phone with the right tools. 

The Next Big Thing is really translating these tools into actions: How can we use wireless devices to change behavior –- the social and psychological aspects?

Thank you, Don, for the inside look at the cutting edge. 

[OK, I'm a Type 1, but I'd still love to beta test the Diabetes Health Phone some day soon.  How 'bout you folks?]

The Pelikan Challenge

I had a fascinating on-site briefing with the folks at Pelikan Sun in Palo Alto on Tuesday.  That's the company that makes the current "gold standard" in lancing -- the world's only electronic and completely painless finger-pricking device (really, it is). 

The three founders are veterans of Hewlett-Packard/Agilent Labs, and have spent 10 years refining the technology they acquired from that company.  What they've come up with is essentially a little "mini-computer" that has "micro-control" over the depth and velocity of the lancing process.  Yada, yada, yada. I don't want to bore you with the technological details.  Instead, I want to tell you about the twofold challenge that came out of my visit.

(that's their fingerprinted front door)

First, I learned about the company's big PR challenge:

"This is the kind of device that can be life-changing, but you really have to touch it, feel it, try it, to 'get it.'  We can't just go out saying 'it's painless, it's painless' because people have heard all that before," says marketing director Lisa Rogan.

The device, launched in November 2007, is already a big hit among children with Type 1 and their parents who've had a chance to test it in person at an expo or camp.  But it's $200 out-of-pocket for the box itself, and another $15 for every 100 finger pricks (50 non-reusable lancets per disk).  "There's no insurance code for an electronic lancing device, so no coverage," Rogan notes, although the disks carrying the needles do qualify as regular supplies.

It's difficult to make the argument that people should shell out this kind of money for a lancing device -- something that doesn't actually change your glucose control in any way -- or that they should carry around yet another bulky D-device, in this case at a somewhat chunky 4 x 2.5 x 1 inches.

We had a long talk about all the ecstatic parents who say their kids and teens are so much happier testing with the Pelikan, and therefore get better control with a lot less family stress. I believe it. I believe there are also many newly diagnosed adults, both Type 1 and Type 2, who would test much more regularly if it were just this comfortable to do. 

But how to get the word out?  Again, you really have to try this thing to become a believer.  And that's kind of what happened to me.

Challenge No. 2:  One Month to Better "Finger Health"?

We all had a close look at my fingertips.  I was kind of embarrassed to discover how pocked and calloused they are, after just four years of this stuff. 

Would I be willing to try the Pelikan Sun for three to four weeks on one hand, while using my regular (thumbtack-like) lancet on the other hand to gauge the difference bruises, scars and calluses?  You betcha!

Essentially they're asking me to help with Challenge No. 1, above, but why not?  I'm always up for an honest review of an honest product.

And truly, I'd like to get rid of those little black spots where the blood is trapped under thickening skin.  I'd like to gain "overall improved finger sensation" so I don't have to keep cranking my lancing device up to top velocity and then jabbing myself over and over just to draw blood.  And then practically needing a tourniquet to stop the flow.

And so I embark on my pain-free lancing journey.  Not that the pain itself ever really bothered me.  But I am more than willing to do without it, and save my wretched fingers at the same time.  So I'm now officially packing the "gold box" with me wherever I go.  I chose my right hand, the one in worst shape, to test the Pelikan Sun's soft touch.  Wish me luck.

If you're interested in testing the Pelikan, here's a short list of some events the company will be attending.  They're also working hard on getting units out to CDEs across the country so patients can try this thing right where they live. 

Who is Diamesco? And Why Should We Care?

Several readers queried me recently on a Korean pump manufacturer by the name of Diamesco.  This company apparently exhibited at last summer's ADA conference, and has discussed plans to introduce its BEST LIFE insulin pump in the US market some time later this year.

"My understanding is that it delivers only meal-time boluses, basal dosing requires a separate injection.  On the other hand it is supposed to be easy and comfortable to insert because of a 'soft wing' and it delivers precise insulin dosing," one reader writes to me.  "What do you know about the company?  Are they considered reliable in Korea?  Any regulatory or PR problems you may have heard about?"

Great questions, My Friend.  I'm afraid the company's web site is a bit cryptic and half-baked.  Which may be a function of language issues and pre-market status.  But it makes evaluation difficult at this point.

From what I can tell, the BEST LIFE pump comes in several varieties, including one that is programmed for bolus dosing only.  The most information is available at this link, which details their special features: the BEST LIFE pump communicates to your computer via a cradle (pictured), allowing you to actually program the pump via your PC screen.  It features extra-simple battery change, and a big, bold readout that uses icon designs "so old people can easily use it without taking pains."  Diamesco also boasts Swiss-designed micro-controlled motor parts for ultimate precision and reliability.

"But it's just another standard pump with tubing.  These are all just bells and whistles -- all cosmetic improvements, not functional improvements.  The technology itself is nothing revolutionary," D-industry analyst David Kliff tells me.  I turned to him yet again for some industry-insider feedback.

"One of most misunderstood aspects of the pump market is that everybody foolishly believes that making the pump itself is the difficult part. It really isn't; it's not brain surgery," Kliff says.  "The big challenges are more pulling together a strong sales team that can sell the product. Then you need insurance reimbursement. Then tech support. And all the incremental advancements your competitors are making..."

A real revolution in pump therapy comes with something entirely new and different, like what Insulet did with the OmniPod, Kliff says.  They were the first to separate the controller and insulin reservoir and make it a wireless system.

What he'd like to see -- and I couldn't agree more -- are smaller pods or "patch pumps" that could be worn longer than 3 days running.  Although the 3-day limitation is about protecting the skin at the infusion site -- rather than an insulin delivery issue per se -- wouldn't it be wonderful to change your set less often and waste less insulin all around?

In terms of reducing the profile of those pods (ie making them flatter) this will likely become possible by employing higher-concentration insulin, Kliff says.  The current standard we all use is called U100 insulin, or a concentration of 100 units of insulin in 1 mL of solution.  But there is also such thing as U200 and even U500 insulin, which has 500 units of insulin in 1 mL.  This type of insulin is rarely used, mainly for people with severe insulin resistance. 

[A spokesman for Eli Lilly tells me that Humulin® U-500 Regular sales amount to only 5 percent of the company's overall Humulin sales, but use is rising along with the epidemic of obesity and Type 2 diabetes.]

According to Kliff, Insulet is experimenting with using this higher concentration insulin in its pods with some of its OmniPod patients now.

"Imagine if you could wear a pod longer, or have a much smaller profile pod.  With U500 it could be smaller profile AND maybe you could wear it for 5 or 7 days.  That's the kind of pumping improvement that matters to someone like me," Kliff says. 

Amen, Buddy!

Regime Du Jour

A few notes today on what's up with my personal diabetes regimen:

I restarted the Guardian RT continuous monitor a few days ago.  I find that I have to take breaks because my poor belly is scarring up fast due to long-term OmniPod and other sensor wear.  As a result, I'm getting many more frequent occlusion errors -- which means a clog or blockage at the infusion site.  In this case, it's not a tubing or even cannula problem, just a problem of too much thick skin (scar tissue) in the areas where Pods and sensors actually stay on my body.  I do wear the OmniPod on my arm in-between, but I haven't yet figured out how to get the Guardian MiniLink sensor placed there.  And here's why:

The most gi-normous needle I have poked into myself since getting diabetes (or ever).  Not liking that thing!  Also, see that big blue device in the background?  That's the inserter-doohickey.  You have to hold it a pretty exact 45-degree angle to get that big fat needle in right.  How do people manage to use this inserter succesfully on their own shoulders or back, I wonder?  I might need to call my friend's husband, the ICU nurse, to help me out here.

btw, the Medtronic folks requested that I note they have customizable early warning alarms to prevent highs and lows, too, just like Abbott's new Navigator (finally coming to market later this year).  The Guardian gives you a choice of up to 30min. in advance, with alerts that can be set for 5 min. increments. There's also a snooze function, that works just like the one on your alarm clock.  Sometimes I think the finer details of certain features are more important to the engineers than the patients, no?   

In any case, have I mentioned the Apidra?  Yup, I started on Sanofi's new faster fast-acting insulin about two months ago.  I "waited it out" since the first month was rough going for me -- running high a lot in part due to illness and infection.  Now that things have settled down, I still have to honestly report that I haven't noticed any dramatic differences in my post-meal BG levels.  What has changed, however, is how rapidly the corrections kick in, which is a nice plus.  I won't be going back to "slower" insulin any time soon (unless I run out of money -- all that surplus Novolog is still chillin' in my fridge).

And here's something neat: I discovered that my little Securitee Blanket insulin cover is just the perfect size for the Apidra vial!  Very handy.  Although I really do wonder if it hasn't occurred to Sanofi how potentially dangerous it is to make Lantus and Apidra vials the exact same size and shape.  I almost mixed them up more than once. 

I'm still loving the OmniPod, except for aforementioned occlusion issues -- a problem that plagues all pumpers at times, I suppose.  Oh, and that episode about 10 days ago when my PDM suddenly died just as I was attempting to bolus in a tiny little chic French creperie in San Francisco.  When I say "die" I mean it let out a piercing beep that wouldn't stop and flashed a message to call Customer Support asap.  No delivery - Yipes!  Of course I had no backup supplies along. 

Luckily, all we'd ordered was a salmon & feta cheese omelette with salad, so I figured I'd be OK until we got home.  Except for the beeping.  No matter how many times I pushed buttons, it just wouldn't stop.  "Is that you, Mom?  Is that still you?!" my 10-year-old daughter asked sheepishly, as the persnickety French cafe owner glared us down.  I yanked the battery, ate fast, and drove home like a demon.

Thus, the rediscovery of my Securitee Blanket to start carrying extra insulin and supplies around, even when I'm not officially travelling.  You just never know. Insulet did FedEx me a new PDM right quick, I might add. Still, lesson learned.   

Thus, this week's