The world's largest organization dedicated to applying technology to treating diabetes is meeting right here in the Bay Area this week (Nov. 10-12)! This under-publicized group has the potential to directly impact the lives of 21 million Americans (according to the Centers for Disease Control) now living with diabetes.
The Diabetes Technology Society is the is the brainchild of Dr. David Klonoff, clinical professor of medicine at UCSF and director of the Mills-Peninsula Diabetes Research Institute, also founder and editor of the monthly journal "Diabetes Technology & Therapeutics."
Starting this Thursday, the Diabetes Technology Society (DTS) will hold its 5th annual meeting at the SFO Hyatt Regency Hotel, sponsored in part by the CDC, the US Army, NASA, UC Berkeley Dept. of Bioengineering, and Georgia Tech's Emory Center for the Engineering of Living Tissues. This year, they expect more than 650 top physicians and medical researchers from around the world -- conferring on new treatments and inventions to optimize diabetes control.
Try as I might, I won't be there (despite living practically around the corner!), because the group does not grant journalists press access to the event. BUT Dr. Klonoff was kind enough to grant me an interview late last week for a sneak peak of what's hot this year:
* CONTINUOUS GLUCOSE MONITORING: Dr. Klonoff says the biggest roadblock is the lack of a universal standard to aid the FDA in evaluating these exciting new products. In a move that will hopefully "jumpstart" continuous monitoring product approval and innovation, DTS has established a global expert panel to help craft standards for performance of continuous monitors.
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This quest to cultivate continuous monitoring is by far the biggest issue this year. The panel's goal is to propose a set of standards that goes beyond today's static measures of point accuracy. What's needed is a mathematical formula for evaluating the ongoing "trend data" that new continuous meters will provide. The FDA is not obligated to accept the panel's recommendations, "but they have told us that the method we're using -- bringing together these types of world experts -- usually results in reasonable standards and adoption of those standards," Klonoff says.
If and when a universal standard is adopted, it would immediately step up the FDA approval process, getting continuous monitors into patients' hands much faster. Also, the introduction of universal standards in any industry tends to promote a flurry of activity, since engineers now have clear guidelines for developing new products. Cross your fingers for the panel's success!
* THE "ARTIFICIAL PANCREAS" CONCEPT: the latest in many years of pursuing a "closed loop" system that combines continuous blood glucose sensing and insulin delivery. Development is particularly slow going because of the high risk factor: lives would depend on a machine that decides when and how much insulin to deliver. Substantial mistakes could be fatal.
Understandably, there are quite a few obstacles and concerns on this one. Besides a "patient override" mechanism, other important elements to build in might include a glucagon store to counteract overdoses or exercise, and perhaps a pedometer as a source of information on physical activity -- so your "pancreas" knows when to reduce insulin delivery.
Anyway, perfecting the continuous monitor is key here. Once that half is in place, it's a matter of connecting that device with an "automatic" insulin delivery mechanism -— some kind of "sensor-augmented pump." Klonoff says developers are experimenting with both internal and external models.
* ALTERNATIVE INSULIN DELIVERY: Inhalable Insulin from Pfizer and Sanofi-Aventis, TechnoSphere inhalable insulin powder from MannKind Corp., large porous particles from Eli Lilly & Co., "aerosolized" from Novo Nordisk, buccal (cheek) insulin delivery from Generex, and even a nasal spray from a company called Nastech. Where are we now?
The FDA has pushed off the Exubera vote until January, but that's still just three months away! Dr. Klonoff says setting doses for the inhaled insulin is not as difficult as it sounds, and that it most likely WILL be approved by the FDA for "specific patient profiles," i.e. adults with healthy lungs and no additional medical conditions.
Nastech, on the other hand, is just now beginning to test its nasal-spray insulin on human patients.
The most colossal impact of non-injectable insulin will actually be on people not now using insulin, Klonoff notes. The easy and painless delivery systems will "break down the barriers" to taking insulin and could thus help millions of Type 2's get their diabetes under better control.
* NANOTECHNOLOGY FOR DIABETES CARE: The science of tiny molecular particles has tremendous potential for helping treat diabetes:
~ glucose-sensing "smart tattoos" made possible by polyethylene glycol beads that are coated with fluorescent molecules. Still in early development stages, but showing promising results in tests with rats.
~ a new generation of ultra-powerful biological sensors will be highly useful for improved and/or implanted glucose monitoring
~ "Nano-engineered" particles can improve insulin delivery in the body
~ A myriad of uses for drug development and tissue regeneration
* ANNUAL DIABETES TECHNOLOGY SURVEY: This is the cool interactive part of the conference. All the experts in attendance get to vote on which drugs and technologies hold the most promise, which they expect to come to market quickest, and so on. Engineers and researchers take their cues here, so the vote has a direct impact on industry activity. (Results are published in the Diabetes Technology & Therapeutics Journal.)
* STANDARDS OF CARE: Other topics include standards of care in the hospital (some of the worst glucose monitoring apparently happens in the hospital!), and the notion of moving away from pure focus on the A1c number to a more quality-based measure of glucose levels over time.
The catalyst for the latter is of course Dr. Irl Hirsch's acclaimed work around using the standard deviation to evaluate glucose level "swings" rather than relying on a simple average. The A1c number may well be an "artificial" middle point between severe highs and lows.
So, you're probably thinking (like I was): What about pursuing a cure?
Dr. Klonoff says: "A cure will probably occur someday in the future, but that day might be 50 years away. Meanwhile it's important for the scientific community to be funding engineering research that will help people RIGHT NOW ..."
"No other disease requires so much patient monitoring, and people with diabetes can benefit greatly from technology that will let them monitor their sugar more easily, more accurately, and more often -- that will help insulin be delivered more easily, more exactly in terms of dosing, and more often..."
"There are many steps that people with diabetes need to take that will be solved by better engineering."
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