Toward the Holy Grail of Diabetes Management
August 21st, 2007 by Kevin
Bennet’s recent post asking for the Holy Grail in diabetes technology (and I’m totally with you on that cure thing, too) at his blog got me to thinking about a few things this evening. Mainly that his wish list, which is shared by just about everyone in diabetes land, is exactly in line with what we’ve been working on here at Diabetech. I can’t believe it’s already 2007 closing in on 2008! Always pushing to get things done faster but life seems to move ahead at its own pace.
Personally, my experience and my earliest investigations into the pace of innovation and the business models of the incumbents led me to believe that this Holy Grail would be a long time coming if ever and I had some insight and passion to contribute to the mission. So, I drew up a plan, redrew it and redrew it. Like they say in entrepreneurial circles, “If you want to make God laugh, show him your business plan”. Keeping the goal (or Grail in this case) in mind is key as I mentioned in a recent article in Medical Products Outsourcing magazine.
2001
May 21, 2001 - My 27 month old daughter was diagnosed with type 1 diabetes. With a professional background in wireless devices, wireless networks, telco infrastructure, software integration and hospital information systems I had a few ideas about how far behind the times current diabetes technology was and a few ways to make improvements.
2002
During the Spring of 2002, I had a call with the medical device team at Eli Lilly to discuss a comprehensive design for an automated diabetes management system capable of delivering the right information, at the right time to the right person… on a silver platter. Following the call I was told that this device and system were the closest thing to the Holy Grail they had ever heard of.
The notion at the time was that day to day management of diabetes was already a lot of work. Adding tasks for the patient with diabetes and his team would only be seen as extra work and few people would be willing to do anything beyond what they were already busy doing. In the world of insulin dependent diabetes this means multiple daily blood glucose checks, insulin injections or pump management and counting carbohydrates for every meal and snack. Tracking this data and relevant comments can be a lot of work not to mention doing something with this data including trend analysis, trend identification and translation into a change in regimen across a virtual team.
We knew we needed to get as much of this data as possible by automatically connecting to diabetes devices like glucose meters, insulin pumps and maybe even insulin pens via a wireless module since this technique would allow us to automate the collection process while also improving accuracy over any kind of manual self-reporting method (e.g. - web, phone, fax…). We also knew back then that additional sensor data would be interesting for automatic collection of data like temperature, activity levels, heart rate, blood pressure, etc… and that the implementation of the device would require a new package in a form factor that would allow it to not be seen as extra work. Messaging would be a very important part of our system but it would also have a customized dashboard which allows every member of a patient-centric team (including the patient) to tailor the system to be whatever they want it to look like while focusing on being easy and fast to use.
December 20, 2002 - Original clinical trial of the GlucoMON® as part of the world’s first End-to-End Wireless Diabetes Management System. This trial must have been the first if not one of the first examples of how you use glycemic variability to assess risk across a large patient population… automatically! Who knew then that SD and GV would become such a buzz in diabetes care.
2003
In early 2003, Diabetech led an effort to standardize diabetes data formatting and sharing called Diabet-ML. We borrowed the Diabet-ML name from Scott Hanselman - one of the early pioneers in diabetes data management software. Bernard Farrell has recently picked up the torch on this one via his microformats and diabetes data wiki initiatives.
Clinical trials continued throughout the year focused on usability and efficient methods of interaction - simplicity.
2004
In 2004, Diabetech’s GlucoMON helped us to earn the 2004 Niche Patient Monitoring Competitor of the Year Award from industry analyst firm Frost & Sullivan. They loved the automated nature of the GlucoMON and its unique ability to connect the diabetes patient with their remote caregiver(s) in real-time without any extra work by the patient (ie - no cell phone, computer, cables, Internet, or button pushing required).
Also in 2004, we announced GlucoDYNAMIX version 1.0 as a comprehensive hosted software service including wireless airtime, data collection, data storage, analysis and feedback with device support for GlucoMON (incorporating data from the Ultra) and published a paper describing our vision as the Real-Time Virtual-Loop.
2005
2005 was the year we kicked off research into Real-Time Virtual Patients; an investigation of real-time two-way communication on the way to developing personalized predictive algorithms for accelerating the realization of what we call the remote control artificial pancreas.
We also began developing several detailed clinical protocols that we like to call Intensive Management Protocols or IMPs. Given all of the people and the data and the devices and all of the decision points and different ways to present data, request data, etc… we figured out the best (only) way to make sense of it all is to package and test defined configurations. For example, the system works one way for a newly diagnosed child with type 1 and in a very different way for an adult with type 2 and still differently for a teenager with type 1 starting insulin pump therapy.
We also began the design of GeNI - Glucose Nanobiosensor Implant. Our design incorporates the smallest implantable cgm on a chip (1mm x 1mm) with short range wireless communication to the handheld mentor which also includes long range wireless supporting remote connectivity, automation, GPS, software updates, etc…
2006
Several of these protocols (including Pancreatic Islet Cell Transplant Screening & Monitoring with Baylor Research Institute) are currently in progress with patients throughout the US delivering some very exciting outcomes while others are closed with data published recently at the ADA Scientific Sessions. We also began getting more phone calls from large companies like AT&T and the big diabetes companies wanting to collaborate. We also began implementation of a USDA federal grant for our technology to support a regional diabetes care network with Driscoll Children’s Hospital based in Corpus Christi, Texas, serving kids with type 1 and type 2 diabetes throughout South Texas.
Fast forward to 2007
Here we are knocking on the door of 2008 and planning for commercialization based on years of experience involving patient-centric design, development, testing and retesting… The time is coming finally for more of that Grail thing from Diabetech for more people and we are prepared to continue our leadership in helping to make your wishes a reality. If you share Bennet’s wish and mine for the Holy Grail, why not give us your vote in reply to this Monster post and help spread the word about the Diabetech® technology. I always thought I would write a book about this experience but I didn’t think I would start writing it tonight.
Thanks Bennet.
Last 5 posts by Kevin
- What's in a name? - March 7th, 2010
- Steve Ponder MD, CDE - Headliner Extraordinaire - January 22nd, 2010
- Fallen Hero Now a Competitor? - January 20th, 2010
- Man Made Barriers to a Man Made Solution - January 16th, 2010
- Healthy Families of South Texas - Launch Day - December 31st, 2009


August 21st, 2007 at 9:38 am
Kevin
Thanks for this excellent timeline of the work that you’ve done. It’s quite amazing.
Is the spec for Diabet-ML online anywhere? I’d love to look at that.
August 21st, 2007 at 10:21 am
Hi Bernard, thanks. I’ll have to pull Diabet-ML out of the archives… tell you what, I’ll do a blog post about it to kick off a discussion. - Eric
August 21st, 2007 at 12:38 pm
I should have mentioned that what’s key about the 24 hr time slot report and the automated review method is the ease of use and time savings that this format presents to even novices. Refined through multiple clinical trials, anyone can perform frequent trend analysis in as little as 15 seconds. This compares to the current alternative of 30 to 45 minutes using other methods including manual charting and software/device uploads to PCs.
CDEs recommend that the patient perform self-analysis for trends every 4 - 7 days but practically nobody does this - it’s too hard and takes too much training and too much time. People using our system typically look at their trends every 3 - 5 days and rarely go more than a week between analysis.
Simplicity is the key.
August 21st, 2007 at 12:56 pm
Hey I found it!
Thanks for all the effort you have put into Grail hunting. (Guess what Broadway Show we took the family to last week) I printed the real time virtual loop paper and will pour over it.
I think that with the huge influx of data that will come from CGMs making sense of it will become a problem / opportunity for the diabetes community. Thanks for being in front of that.
June 1st, 2009 at 11:01 am
Fast forward update to 2009 - payers are paying!!! Finally and thanks to hard earned results from randomized, controlled clinical trial results from several hundred patients monitoring the effects of one year continuous use of our GlucoMON-ADMS. The crossover portion of the latest trial is occurring now with final results ready in early 2010. While we have tested several business models, the one that has traction is our diabetes program model - an enhanced disease management program that focuses on technological movement of data and information vs. the traditional call center approach. I think what I am most excited about is the opportunity to fine tune these niche programs and include whatever we need (ie - innovative technology, new connected devices, etc…) to get the measurable patient outcomes. This is a game changer for health care delivery models in the USA!