Shortly after my daughter was diagnosed in 2001 I learned about the juvenile diabetes research foundation and the great work they had been doing to find a cure for her diabetes. Over the years I held hope that their investments in promising research done by trail-blazing scientists would pan out before she became an adult and had to deal with the potentially deadly effects of low blood sugar at night and awful complications from high blood sugar over time.

Through the course of the past 8 years I have gradually stopped trying to figure out how to get JDRF involved in the innovative research that I’ve had a hand in. My research has been focused on the here and now - lower hanging fruit for sure vs a cure found in the lab. In addition, mine is a commercial venture focused on helping people to more easily manage with the help of information technology in the form of wireless devices and some pretty slick software.

It’s taken a few $million to get here from a combination of credit cards, friends and family and the ability to win several competitive research grants from federal agencies and lesser known medical research foundations. We recently announced preliminary results from our most rigorous scientific study that showed how our technology, in the hands of patients, provides a clinically significant benefit vs. the current standard of care (ie - a full point reduction in A1c and reductions in glycemic variability all without the dependency on additional visits to the clinic or participation by their medical providers). A subsequent peer review and publication will be the final judge but I can already say that we now know a few special things that can be done today at very low cost to have a significant impact on reducing complications from type 1 diabetes.

I used to think this goal was something I had in common with the JDRF and always struggled with the fact that there has never been a constructive dialogue with them - only my pleadings and attempts to share what I have been learning along the way. Nothing ever came out of those discussions - absolutely nothing. Yet, the data shows that Diabetech and our research partners have the stuff that mitigates complications and makes life with diabetes easier for all concerned.

In light of JDRF’s recently accelerated behavior as some kind of new wave Robin Hood who takes donations from families who walk for a cure and gives millions to large multi-national corporations, I have to wonder if they are now my competitor? I also wonder if this precedent will stifle a company’s future willingness to fund R&D out of their own pocket when they know there is this JDRF bankroll in the wings? What about new investments into this field that don’t involve JDRF? It seems like that just got riskier too since your new fledgling project might find itself up against a giant waving the JDRF banner. So did they just monopolize innovation regarding diabetes technology?

Weird.

This is a response to this article at diabetesmine.com which talks about your invention for a non-invasive glucose monitor that would take readings through the skin on your ear.

Hi Larry, my company can help move this forward through the clinical trial process with much of what you need at the lowest total cost for your next step. Gluconix for clinical trials.

The path isn’t impossible but the incumbents didn’t make it easy (on purpose I’m afraid). The safety issue must be managed as part of a plan that moves you toward commercialization but that doesn’t necessarily mean that you can’t get this in the field to demonstrate that it works (or maybe not). You can go to our website to send me a message.

We’ve also figured out how to win $1.5M in competitive grants to date helping to support randomized, controlled clinical trials of our ADMS as we move toward commercialization so that might come in handy, too.

My message to Larry was also posted as a comment to the article.

Link to the story to see a video of a day in Daisy's and her family's lives

Unless We Make Some Changes…

Read this story from the BBC for yourself. We’ve seen this dramatic increase in type 1 already starting about a year ago in the diabetes centers that we work with in the USA. Basically, the new cases of kids with type 1 diabetes have doubled!

Historically, the statistics on type 1 in kids is roughly 1 in 400 or 1 in 600 depending on the source. So let’s say 1 in 500. With doubling, that number will soon begin to approach 1 in 250 over time. In the USA, there are approximately 200,000 school age kids with type 1. Another source I read in the past states that there are approximately 30,000 new cases of type 1 each year in the USA and that approximately half of those are school aged kids. Based on this story and recent discussion, it’s safe to say that there are 30,000 new onset cases of type 1 in school aged kids. It used to be that a typical age for new onset (the mode) was around 8 to 11 years. Based on discussions with endocrinologists and educators along with the information in the story, the age of new onset is clearly moving to younger and younger kids. That means more diabetes supplies over more years and more risk of trips to the Emergency Department not to mention more time at risk for complications like cardiovascular disease in the teen years.

My experience has shown me that each endocrinologist working with diabetic patients handles approximately 200 to 400 patients. There are only 200 pediatric endocrinologists in the US and very few docs coming out of med school are attracted to the relatively low pay (vs other specialist alternatives), unbilled hours for telephone consults and logbook review, and lack of control (behavior change is the required skillset vs. diagnosing to prescribe pills/dose change to fix the condition).

While there are something like 14,000 diabetes educators in the US, most of them are trained and experienced on how to work with adults with type 2 diabetes - a very different scenario than working with a kid with type 1 who may also come from a broken home or other family issues.

If each patient requires 6 hours per year (30 minutes per office visit 4 times per year plus 20 minutes per month on average for another hour over the course of a year) and there are 700 trained providers, then there are a total of 1,380,000 hours of skilled care required at a minimum since this assumes no complications. If each provider is available for 30 hours per week of patient facing time, then the current skilled pediatric labor pool is able to provide 1,050,000 hours of patient directed care. Not enough providers to deliver standard care especially when you factor in the doubling effect of new onset. The numbers I use here are only rough assumptions to illustrate the gap in the current health care delivery model for type 1 diabetes. At some point there is a scary reality and a breaking point that nobody is aware of.

Sadly, until the economics are changed to incent providers to work with type 1 kids, I don’t believe we’ll get sufficient trained people to help us with this avalanche of new patients. That leaves us with having to develop new models of care that increase the efficiency, effectiveness and reach of the trained providers we already have as well as making patients better at self-care in the absence of their diabetes coaches. A little technology will go a long way if done right and adopted (embraced) by providers. I’m reminded of a slogan we adopted a year or two ago which is now posted at the top of Diabetech’s home page on the Web, “We’re dragging Diabetes Technology ‘kicking and screaming’ into the 21st Century”. With recent successes made on the payer front, we’re soon going to need to swap out the word ‘Technology’ for ‘Providers’.

My reason for making this post is to raise the awareness that the perfect storm is upon us. Who is doing the study to prove that we need to make changes now - based on irrefutable proof that maintaining the status quo is like using a syringe to bail out a sinking ship?