Wednesday, January 13, 2010

Commentary on the JDRF "Artificial Pancreas" Announcement

Tuesday, Amy Tenderich of DiabetesMine.com was dropping hints on Twitter of a big announcement that would come out yesterday. Like clockwork, yesterday morning, many of us received an e-mail from Amy with a link to her blog post with the news which was essentially a major milestone in JDRF's ongoing "artificial pancreas" project which aims to create a closed-loop insulin pump and CGMS (continuous glucose monitoring system) that can talk to one another.

That project aims to reduce the significant manual effort required of patients and their caregivers in today's intensive insulin therapy protocols, and hopefully expand the amount of time patients spend in the target glucose range (euglycemia) doctors recommend to maintain optimal health. Interestingly, JDRF's own research suggests that the average person with diabetes spends over 12 hours a day with blood glucose levels >180 mg/dL and many others, including myself, spend more time than I should dealing with hypos caused by ever-changing basal needs, changes to insulin-to-carb ratios and the many impracticalities of try to estimate carb content (an artificial pancreas will not address that problem, BTW) in both cases, out-of-range, each day given the serious imperfections with today's treatment modalities. By developing algorithms set to a target range, rather than some arbitrary target number, they hope to significantly improve patient's well-being and their long-term outcomes.

Clinical practice has also suggested that significant glycemic volatility is much more common in type 1 diabetes when compared to type 2 diabetes (see here for a prominent endocrinologist's view on that). The full press release on this announcement can be found here, and is certainly worth having a look at.

I am by no means the first person to announce this (Amy, Kerri, the San Francisco Bay Area's JDRF Chapter blog JDRF Talk blog, Caroline Parker and several others beat me to it), but I think I probably AM probably the first d-blogger to feature the JDRF's video announcement -- I've developed a skill for lifting html code on videos hosted elsewhere and embedding them on my blog and various other social networks including TuDiabetes.org and DiabetesTalkFest.com among others, so I usually don't need someone else to post them to YouTube for me to feature them here. Anyway, the video was also featured in a mass e-mail announcement from JDRF yesterday.

Having a look at the video announcement, it seems apparent that some segments were pre-recorded in anticipation of an announcement with a yet-to-be-named partner. For example, CEO Alan Lewis says "corporate partners" in his clip, rather than naming J&J/Animas and Dexcom specifically, while Richard Insel refers to "one of the major industry players", again not mentioning exactly who those parties were). JDRF also did a mass e-mail yesterday evening on the subject, and included a ;oml the following video. I wish they would make it easier to embed the videos their sites host, but until they do, html code-lifters like me with find a workaround! The video features Alan Lewis (the CEO of the JDRF), Aaron Kowalski, the artificial pancreas project director, Jeffrey Brewer, a JDRF international board member, and of course, Dr. Richard Insel, JDRF's top research executive. Without digressing too much, you may catch the JDRF video announcement here:



Johnson & Johnson Steps Up To The Plate

I cannot help but wonder how much the death of Casey Johnson (one of the heiresses to the Johnson & Johnson fortune) might have played a role in snagging J&J as the partner (as opposed to Medtronic Minimed, another company who makes both the pump and the CGMS systems)? After all, Casey's father is one of the top JDRF board members, and her tragic death was a reminder to everyone that life with a chronic disease such as type 1 diabetes never takes a break.

The Artificial Pancreas May Not Be Quite As "Dumb As A Brick", But Still Needs Work

As Amy correctly referred to this in her write-up, the announcement is really about more of a "first-generation" artificial pancreas that will be developed, because it won't really be closed-loop just yet (actually all that was announced was a commercial partnership; the FDA still has to approve whatever the partnership ultimately produces). This week's announcement may reduce (but will not eliminate) the regular "instructions" as author Dan Hurley (Diabetes Rising) described them required from the patient -- it will be, after all, a first-generation device. If you recall, when I reviewed his new book (released a few weeks ago), Mr. Hurley lamented:

"I finally decided to go on a pump in 1999, after my insurance company agreed to pay much of the cost. On balance, I found it made life easier by allowing me to make minor adjustments in my insulin rates on the fly, but resulted in little change to my A1C numbers. And my lows remained every bit as common as my highs. Essentially, it was just another way, albeit incrementally better, to get the same old insulin I'd always used. And while friends and family often assumed that the pump worked like an artificial pancreas, giving me only as much insulin as I needed, in fact, it was as dumb as a brick, following only the instructions I gave it."

Those of you who read Close Concern's diaTribe understand that what a first-generation system basically means the wearer will still have to "warn" system out by telling the system you'll be eating something so it knows enough to anticipate some carbs, but it is a step forward in a project that has been a dream for many people and in the works for decades. I would not go so far as to call it a dream for every type 1 diabetes patient, because as message boards on the online social media community suggests (as well as Caroline's blog, noted above), the idea is not universally desired by people with diabetes, as much as the companies who stand to profit from this technology would love that to be the case. To be sure, some would like it, but many others complain the CGMS sensors aren't accurate enough (particularly at the hypoglycemic level), the insulin is still too slow, and still others complain the devices are still too invasive and/or bulky and unattractive. I agree with all of those sentiments. But it is a step in the direction and a concrete one, at that.

My Type 1 Pancreas Works Fine, Thank You, It's My Islets That Don't Work

Personally, I've always hated the term "artificial pancreas" because my pancreas works just fine, thank you, but my Islets of Langerhans have been destroyed by autoimmunity. That means its really more accurately described as artificial Islets of Langerhans, and to call it an artificial pancreas implies that patients with type 1 diabetes have broken pancreases, when in fact, aside from no longer making insulin, amylin and glucagon, the pancreas continues to produce all of the digestive enzymes necessary for survival! In fact, the Islets constitute less than 1% of the total organ mass, even if that 1% represents a critical piece of the total. Anyway, this effort was about a partnership arranged by the JDRF with Johnson & Johnson's Animas insulin pump business (truth be told, that was an acquisition by J&J a few years ago, it was founded by Dr. Katherine Crothall, MD, but I digress).

J&J's One Touch Business Not Included?

What makes this partnership a bit unique is that J&J's gigantic One Touch business that makes testing supplies for the company doesn't appear to have a big role in the project, at least not now. Instead, another startup, in this case Dexcom, is the CGMS involved in the project. One Touch does not presently have an approved CGMS device on the market (although competitors Medtronic Minimed and Abbott do). One additional element of interest about this announcement was the fact that JDRF prominently noted that this partnership was not exclusive, which suggests that the organization is also seeking other companies to join in to help with commercialization.

Make Them Smaller, Cheaper AND Guaranteed Covered By Insurance, Then (Maybe) I'll Consider It

I'm not crazy about this announcement because its just a partnership and its not exactly close to commercialization, but I also cannot be too critical. JDRF has spent some money on this (although the organization does not disclose their full budget for it), but from what I can discern, they've spent far less on this project than many other ideas that failed to pan out, plus they have gotten big medical device companies to participate (I'm still p!$$ed JDRF funded the CGMS studies needed to gain insurance coverage, as the companies that make those things have reaped all of the profits and could have funded those for themselves). For many people, these devices could make lives infinitely easier. But JDRF is claiming at least another 4 years is needed before this is ready, and I'm not getting any younger waiting for this device to emerge. This, of course, assumes that the U.S. Fatalood and Drug Administration get's its own act together and moves swiftly to approve the devices, and the way that agency moves, I'm inclined to doubt that's likely to happen on-time.

But I do see why there is reason to be excited for many people, and when it comes to diabetes management, that's typically in short supply. I'll just say this does prove JDRF has the ability to put commercial partnerships together, which is indeed beneficial to people with type 1 diabetes.

1 comment:

Amy said...

Hi Scott,

I agree. I think it's a big step in the right direction. I know 4 years is a long time to wait, but we've already been waiting all of our lives, and without this concerted effort by JDRF, we might have been waiting for nothing...