We've Moved

Challenge Diabetes started as a multi-author blog by Kevin L McMahon and Stephen W Ponder sponsored by Diabetech. The work continues at http://viditza.com

Comments to David Mendosa's Blog 14-10-2006

The classic quote from providers is that they don't want the patient's data sent to their practice and their hope is that somehow patients will magically become more proficient and self-sufficient over time. Diabetes Centers simply don't have the resources to handle that kind of data streaming into their offices and they're not paid to deliver care between office visits.

That's why so much time has been spent conducting clinical research in this area to understand precisely what to do with the patient's data as a form of continuous care given all of the different scenarios (e.g. - newly diagnosed type 1s vs. a steady state person with type 2). There is clearly a level of sophistication required in the management of the data to optimize patient care while increasing clinician efficiency.

A real-time care management platform is essential for turning this raw data into a useful tool for each member of the care team, especially the patient. The burden does not reside with the provider. In fact, most of the patients using wireless meters today depend on our real-time platform for self-management as opposed to waiting for instructions from their provider.

Ultimately, the answer isn't this meter or that continuous sensor, either. It's how the data is transformed into useable information to improve patient outcomes and increase provider efficiencies. To David's point, until we have reimbursement in place, most people cannot afford to buy the cgms let alone the disposable sensors.

For future discussion, the best way to use a cgms is as a wireless device connected to an intelligent real-time system like GlucoDYNAMIX.

Another of David's points is that patients using diagnostic devices in a standalone mode aren't getting maximum value from their data. I've heard plenty of cgms users validate that statement as well when they talk about how much is lacking from the current generation cgms software.

This new category of meter isn't really about the meter at all. It's about a new approach to optimizing patient care through the application of real-time systems which also have the ability to "efficiently" engage their providers on an exception basis using provider-defined rules. For example: "...only send me information when...".

The proof is in the research that shows how patients are getting lower A1c's, fewer hypos, fewer extended hypers, independence, peace of mind, time savings, increased accuracy leading to better decisions by the team, etc... All because this category gives us an opportunity to develop systems that go beyond any single device and focus on transforming data into information which, if you do it right, ties directly to better care. Contrast this with the constraints of a publicly traded company that makes its money by maximizing profits from the sale of test strips or replacement sensors.

Folks in our trials tell me they really like the GlucoMONTM for its real-time alerts and the fact that it isn't limited to the home. It goes with you during your day. Our current trials are the best examples of pervasive technology at play outside of the hospital for people with medical conditions.

As with everything, the current generation GlucoMON has its pros and cons. There is no one size fits all. As such, one thing we realized a while ago is the opportunity to leverage Wi-Fi networks through their many 'access points' scattered here and there.

If you already have a home wireless network or you've seen those geeks with their laptops in Starbucks you can imagine a day when a medical device might just borrow the high-speed wireless connection for a few seconds to communicate with the remote monitoring center.

Diabetech is working on technical specifications (Wi-MedTM) to beef up our devices and the other technology involved to ensure a secure and seemless user experience just like the current GlucoMON. The big difference is that we can close coverage gaps where we need them as well as move into higher bandwidth applications---like real-time streaming video related to your real-time disease state. Our current research has shown us how to use this technology as a new feature to deliver improved outcomes even beyond what we've already demonstrated.

Our Mesh Wi-Fi Medical Device Testbed is now alive and kickin' in Deep Ellum. This is an old blues neighborhood full of eclectic shops and nightclubs and more and more residents living in lofts - the edgy side of downtown Dallas!

So next time you logon to the Internet with your wireless laptop, think about Diabetech as the company leading the wireless healthcare industry by automatically connecting your glucose meter, insulin pump, blood pressure monitor, implanted cardio-defibrilator, ECG event recorder, etc... to your virtual logbook, doctors, nurses and family members. Several years ago someone said to me after a JDRF event following a talk on the GlucoMON; "Hey, that sounds like OnStar for diabetes!" I said, "Better."

T1 Diabetes Imposes Travel Requirements

Diabetes House Call to the rescue

I just read about another family of a 16yr old with type 1 who travel 100 miles each way to see her pediatric endocrinologist. This is so common that many just take it in stride and even more settle for care by an unqualified primary care physician with little to no background in type 1 diabetes let alone the specialized knowledge required to manage growing children and the family dynamic.

"There are more than 100 families in the Fredericksburg area who have children with this chronic disease, and we must travel over 100 miles round-trip for our children to be seen."

This from a mom who has raised probably over a half-million dollars for research since her daughter was diagnosed over 15 years ago. Meanwhile, every 3 months they stop what they're doing, get in the car, travel to the specialist, sit in the waiting room and then if they have the same kind of visit as many other families that I know, they will spend more time paying their co-pay than they do with the endo. It's commonplace to spend no more than 5 to 10 minutes with the doctor and only twice a year in many settings. Most of the time is spent waiting and then only to be seen by the diabetes nursing staff.

"...there are a lot of children here in need of this type of specialist. We are getting tired of waiting. There are veterinarians virtually on every corner in this town. Why can't we get one good endocrinologist for our kids?" says Lisa Taylor, mother of the 16 yr old w type 1."

What if you could have a telemedicine visit with your endo from home for visits when everything is going well? That's what we're testing in Texas with Diabetes House Call™. It's cool stuff and will be coming to people in a few additional states by mid next year - the lucky families living in Texas will have access to DHC this year!

This is healthcare for people who get what they need vs. healthcare for people who take what they get. If you look at the costs of diabetes imposed travel, you'll see that it's not cheap. My family spent over $2500 a year when our family traveled to get care in another city in order to get what we felt we needed for our daughter - an insulin pump. Hotels, gas, meals, lost work, etc... it ain't cheap and we weren't loaded but we made it a priority.

Bottom line is that our work with select Endos across the country will deliver what Lisa Taylor is asking for and deserves. The only question left is will those families make it a priority or will they simply continue to take what they get? We'll soon see.

Expanding Influence On Clinical Trials Research

To see Diabetech's current published clinical trials click here:






To enroll in the real-time alerts & social support networking study click on this link.

What the World Needs Now is Accurate Data

Patient Reported Data - true, false or somewhere in between?

I just ran across this great stash of information from a presentation entitled, "Smart Pumps And Tomorrow’s Intelligent Devices", (warning - 10Mb download but worth it) given by the esteemed John Walsh from July, 2005. In his presentation, John cites a study (1. JB McGill et al: Diabetes 54 (Suppl 1) poster 2035-PO, 2005):

In a study1 that compared logbook entries to meter downloads:

* • One of every seven entries was not recorded because it was high

* • One of every seven entries was made up

* • No difference was found between adolescents and adults in the entry of fictitious and missing data

* Time and date settings in meters are often incorrectly set. This causes patterns of high or low readings to be associated with the wrong time of day. Insulin adjustments made on faulty timing can worsen control rather than improve it.

(Back to me blogging)...It's so obvious isn't it that all of this talk about medical data is still, in this day and age, mostly talk? I stumbled across part of this problem back in 2001 when we first started using a glucose meter. Magically, the time on the meter would change. Come to find out, that's a fairly common occurrence for all current generation glucose meters and probably for all medical devices in general. Other causes include never setting the meter's clock in the first place, daylight savings adjustments, and who knows what else. Come to think of it, I still don't think I have ever set the clock on a VCR. Then we worked with patients in our first studies and found out how frequently numbers were transposed/ommitted/forged, etc...

Our patent pending BioTimeSync(tm) feature has solved the clock accuracy problem around timestamps and our 'always-on' data collection technique has solved most of the issues around inaccurate values. I say most because there are teenagers who use these meters and give a teen a medical device and you can bet they'll find a way to beat the system. I will not divulge those 101 ways to fool your parents here however.

Those little gems are best left unpublished!

Let's Define Continuous Glucose Monitoring

When Is Continuous Not Really Continuous?

Lots of people I talk to are confused about the various approaches to technology and how they will be used to improve diabetes care and subsequently outcomes. I think most people would agree that having a way to monitor glucose continuously will be a good thing. However, when you stop to think about it, what definition of 'continuous' are we talking about? I would bet that if you asked 100 people with diabetes to give us their definition we would get at least 4 or 5 different answers.

As the technologies are getting closer to reality and delivering a useful and practical advancement in the state o f the art, we will most likely need to come up with more useful ways to describe these new devices and how they benefit us beyond just using the word continuous.

If you look at how everyone is using the word 'Wireless' across many different ways that it is used in diabetes you know what I mean. Wireless Diabetes Management System - is that for eliminating a cable between the meter and a PC, automatically inserting glucose values into a pump, using a handheld device to send commands 2 feet away to the insulin pump, or wirelessly transmitting useful data and information around the world from the patient in real-time to somebody else who can make effective use of the data and reports? Wow, that's a lot of different ways to talk about wireless in the context of diabetes!

With 'Continuous' we really have an even bigger challenge. Currently, most people who pay attention to this stuff think about continuous glucose monitoring as a 2 or 3 day wearable device with an inserted sensor or even a watch that you wear similarly for 2 or 3 days. These devices while continuous in the sense that they give us glucose data every several seconds or minutes can only do so for a very short period of time. These sensors are certainly not continuous and the continuous drain on a person's wallet may also prevent the current versions from ever being truly continuous at $15 a day (ouch!).

In addition, who among us really wants to deal with Continuous Glucose Data? Lots of us are working hard to address that problem by adding some intelligence to the data that's created so that it can be made more manageable and realistic in its usefulness. "Just tell me when I'm going high or going low", for example.

Another version of Continuous would have to do with getting data perhaps not every 5 seconds but delivering spot test data 6 to 12 times a day to an interested caregiver each and every time a test is taken... for years on end, continuously! That's the kind of thing we've been doing at Diabetech for the past 4 years with our GlucoMON wireless glucose meter accessory device. We just announced our GlucoMON Right Now! Diabetes Technology Study this past week and are busy recruiting people from around the USA to participate. Quite simply, this device allows people who depend on others for mentoring and support to be continuously monitored day after day after day each time they test and to continuously receive trending reports. Real-Time Alerts are a major part of this study as we want to better understand how people use this information away from the point of care and if it improves glycemic control and various other quality of life issues.

Wait! I just introduced yet another phrase we need to better define; Real-Time? So what does that mean?

Take Action Now

S. 1955 will jeopardize lifesaving coverage protections for millions with diabetes by allowing health insurers to circumvent existing laws in 46 states that guarantee coverage for diabetes medications, supplies and training.

Call your Senators ASAP.

The World's Most Compelling Content!

What if you only knew how a loved one was doing at any given moment in time? Would that be more interesting than getting a text message about Google's stock price? Maybe. What if you were a physician and you just told the patient to change their medication dosage (ie - insulin)? Wouldn't you (shouldn't you) be interested to know the effects of that recommendation...as it unfolds?

I've spent a lot of time in the world of Mobile Commerce, ePayments, Web Portals, Proximity Services based on location, etc... prior to starting Diabetech and I recall too many international conference calls where we all tried to define/predict what would be 'compelling content' (as they call it in tech speak). Sure music videos are cool and those iPods are hot but I've got to tell you, people in our studies using real-time blood glucose information rave about the power of real-time data and how they use it to facilitate a timely intervention. The funny part is that people tend to become addicted to this 'compelling content'. The behavioral psychologists reading this know what I'm talking about.

One of these days I think I'll ring up those blokes on the telly and see if they've been able to figure it out yet?

I Dream of GeNI™

Continuous Glucose Monitoring Goes Small!



You can imagine how excited I must be along with all of you with the recent progress in the field of continuous glucose monitoring. It appears that DexCom is coming along nicely, patients are getting some real-world experience with the Guardian RT and we are far enough along in our own program to announce a collaboration with Zyvex, THE leader in commercializing nanotechnology. Let me say that again. The leader in commercializing nanotechnology! That means that for them, as well as for Diabetech, we're not satisfied until the technology we're working on makes it into the market and delivers real benefits to real people.

This is not a research collaboration. It's purely about making a system that works and taking it to market. That's why I hope you're as excited as me with this announcement. Now before we fall prey to hype-mode blogging, I must say that this project will take at least 2 years to make it to human trials and there are of course many challenges to overcome. Regardless, we'll expand our net to cover a broad audience of committed problem solvers and leverage everything we can to make a user friendly system making it possible to aggressively and safely control glucose levels.

$0.50 per Patient per Year

Capital I for Internet (it's the only one)

I run across many diabetes programs, technology and clinical trials for new twists on diabetes programs and of course, each one is special and each one involves the people with knowledge looking to impart that knowledge on those with diabetes. In classic educational system style, knowledge osmosis is believed to flow across all participants and hopefully some patients can retain and apply this newly imparted knowledge to their own benefit.

This paradigm has certainly benefitted millions of people with diabetes so far. However, the pace at which diabetes is expanding is far exceeding the System's ability to keep pace. Note the recent series in the New York Times - a raw piece of journalism that was quite honestly difficult for me to read due to its honest portrayal of diabetes and its lack of 'sugar-coated' personal interest styling.

One piece of information that I came across not too long ago has been especially troublesome for me. In the arena of Public Health, the goals are not necessarily or realistically applied to individuals but to improving the lot of a larger population. One population based diabetes program in the NYC area, coincidentally, told us that they only have a diabetes program budget of 50 cents to spend for each patient in the greater Metropolitan area of several million people. Consider that approximately 7% of the population has diabetes. That's a lot of patients. I'm just not sure how much you can really expect to accomplish within a classical education paradigm given that one stamp per patient per year could consume 74% of that program's budget! "Aha, then let's put up a website and save that postage." With the rise of the Internet, unfortunately too much of the research and focus of diabetes program managers has the Internet at the center of their diabetes education strategy. Consider that there are still millions of patients who lack convenient access to the Internet and that this same demographic also has a disproportionate share of the diabetes in this country. Alas there is no panacea for getting the word out. No one size fits all approach to improving our future.

There is no shortage of technology; no shortage of test strips. No shortage of paper or Emergency Room trips. But what will come to light in 2006 is how much emphasis must be placed on interpersonal communication as a powerful diabetes program and not from a program designed in the classical diabetes education model.

Radio Comes of Age

Web, TV, Text Messaging, Email, Now Radio, too!

It seems there isn't any place to go any more where you can't learn more about diabetes, what progress is being made toward better management and the cure and tips for better self-care.

Diabetes Compass Radio is a new radio show with playback on the web that you should check out. Based in close proximity to the great work known as the Edmonton protocol and hailing from the birthplace of insulin therapy, Diabetes Compass has great access to some real movers and shakers in the field.

Dianne Lehman is the driving force behind Diabetes Compass Radio. She's working hard to make sure that all of the hottest new innovations in diabetes care are made available to the people of Alberta and Canada in general. With our recent launch of service in Canada, it's nice to have friends like Dianne.

Check out her site and show and let me know what you think.

Message From a 2Way Device

Challenge Diabetes Goes Mobile!

Have you ever stopped to think about how ironic it is that so much diabetes management & education requires the patient to sit in front of a computer? Let's think hard going forward how to make healthcare tech mobile.

Sent from my Communicator wireless text messaging device

Who Needs To Know?

Share the Data - Step 2 of the Virtual-Loop(TM)

Assuming we have accurate data from meters, pumps, etc..., what should we do with it besides store it in the device for later review?

In the case of continuous real-time glucose sensors with intelligent alarms, who needs to know about the impending hypoglycemia and the rate of onset? As a friend of mine who is also the parent of a child with type 1 diabetes recently pointed out, automated passive delivery of this critical life-saving information to someone who can help in addition to the patient is a far safer system design than what currently exists on the current investigational stage continuous glucose sensors.

Of course there are endless uses for diabetic data if you can get it, rely on it and ultimately act on it...and understand the effects of specific actions. For example, clinicians typically do not receive timely feedback from patients following prescribed changes to their insulin regimen. In that scenario, the feedback loop is broken and the prescriber too often has no timely insight into whether or not their advice is improving the patient's glycemic control or worsening it. At some future date the clinician will have the A1c to point out averages but that's a far cry from tying intervention to its effect. Unfortunately, the A1c does not illustrate the incidence of hypoglycemia which may have been increased due to the clinicians advice.

What if there was a way to reliably and efficiently close the loop - delivering timely and reliable information to the prescribing clinician about effects from the prescribed change? The Virtual-Loop can... and it doesn't depend on continuous glucose sensors someday in the future.

Technology working together seamlessly for patients, caregivers and clinicians is a beautiful thing.

Why Real-Time?

Get The Data - Step 1 of the Virtual-Loop

Many, many clinicians I've met along the way who are first introduced to the concepts involved in Diabetech's Virtual-Loop look me squarely in the eye and say they don't have any need for a real-time system. Fortunately, I've learned not to argue and convince.

For the clinician with an open mind however, it's a very simple problem we're working to solve. That problem is this: When do you need to have diabetes patient data? Every Friday afternoon at 3pm? No. You don't know when you need it until you know you need it - it's unpredictable.

So, a real-time clinical information system is really about a method of constantly collecting patient data in advance of actually needing it. That way, when you need it, the clinician can actually use it to make better decisions ;)

The Pain Free Glucose Meter?

Please...
I had to laugh, in a disgusted sort of way, as I was just marketed to (again) about the glucose meter that's "virtually pain-free". This time it was on prime time TV. A different glucose meter company used a similar ad strategy in print ads selling their new meter by claiming "less pain" with a teeny, tiny footnote about a small sample size and their 33 gauge lancette. (Awesome lancette and lancing device by the way!!!) However, not tied or limited to their meter in any way, shape or form.

Last time I checked with my daughter the pain part of testing has nothing to do with the meter but rather the thickness and depth of her lancette. She even says the lancing device used makes a difference. But the meter? People with diabetes deserve better and I know we can deliver better.

GlucoMESSENGER In the News

diabeticfeed has the scoop
My new friend Christel Marchand called the other day and asked me about what kinds of things we do at Diabetech. Well, about an hour later we said goodbye. My apologies to Christel's ear but when I found out she was technically minded she got the backstage pass. Christel's new weekly mp3 feed is designed to connect all of you iPod downloaders with breaking news about diabetes while you're on-the-go (I absolutely love that part!!!).

Check out her site and listen to her show and find out about GlucoMESSENGER for real-time diabetes messaging on-the-go and other breaking diabetes news while you're at it.

Grassroots Fundraising

operation cure the kids

Along with a few of my friends in the world of diabetes, we're introducing a program to encourage companies to pander to the diabetes community. Operation cure the kids is in its infancy and is already attracting interest from diabetes and non-diabetes related companies alike.

If you read my blog you get the scoop so stay tuned as we finalize the program and secure additional program participants. Companies will register with the OCK committee and secure a license to the logo. This logo makes it easy for us as consumers to change our buying habits in support of companies who donate to the diabetes cause. The companies who register with OCK must clearly and responsibly report their actual donations. Bottom line, if you see this logo, the company selling the product has committed a portion of the proceeds to a qualifying not-for-profit diabetes related organization...and you can verify it! If you know a company that would like to participate in the program or a non-profit organization that would like to be considered as a recipient of these funds please let them know that they can get more information by contacting me at kevin@diabetech.net

More soon.

Friends Helping Friends Manage Diabetes

Let's call it GlucoPALS

A while back I had a conversation with a young man about managing his own diabetes, how that works with his mother(and sometimes doesn't work), and what would happen if teens were given more independence by working with another teen with diabetes. Andrew wrote up that concept and told me that the "Buddy Protocol" (my description) wasn't going to fly. I think he suggested something about pals and thus the concept of GlucoPALS was put to paper.

It really is a powerful concept documented all over the place; pen pals, fitness partners, diet partners, business partners... Why not diabetes pals? So, we have a study getting underway designed to better understand what happens when a couple of teens use real-time communication to help each other manage through the day. If you have an interest in contributing to the final study design or participating, please send me an email. I expect this first go will become quite large throughout the US and Canada followed by a more formal study. Look for frequent posts here on the experiment. I suspect GlucoPALS will start its own blog, too.

A hint at the "Virtual-Loop" (my original post): it encompasses the closed-loop but is not limited to it.

Update From TLC

Next Year's Camp Resolution

...to make a list. Well, I forgot my towel, shampoo and soap! It's always something every year. Fortunately there's a Walmart in every town. Camp is crazy as always - kids pushing it to the edge and having a great time. Meanwhile the MedStaff is keeping long hours and making for a safe environment with lots of fun for all.

We visited the Museum of Western Art in Kerrville, Texas today which was displaying several hundred incredible bronze sculptures and paintings on loan from the Kennedy family of Chicago. Quite impressive! The kids were apparently just as impressed. I was proud of their ability to shift gears from 'Camp Mode' to 'Museum Mode'. The volunteers were left with a great respect for the kids and a little more educated about a day in the life of people with type 1 diabetes.

Back to work...

Texas Lions Summer Diabetes Camp

Hello Camp - Good Bye Sleep

Well, it's off to camp tomorrow. I wonder what I'll forget to bring this year? Hopefully it won't be something too missed. This is my third year at camp and I definitely look forward to it. Over 400 kids each year attend this camp and not one of them has to pay a dime. That's cool. I tell people who don't understand type 1 diabetes what's so special about camp is that for many if not most of the kids, this is the one time each year that they get to "let it all hang out". It's an environment staffed with so many excellent people who know how to spot lows and highs and take corrective and preventative action. The kids seem to sense this and maybe for one or two weeks each year, they act like a regular kid at camp. Off to packing everything I need... everything except for that one thing!