DT&T days 1 and 2 ~ continuous update and much more ...

Today marked the first day of the sixth annual Diabetes Technology and Therapeutics meeting, and discussion focused on continuous technology – where we are and where we’re going – with afternoon sessions on hypoglycemia and the artificial pancreas. Some quick highlights of today’s first day and yesterday’s pre-meeting workshops:

1. the STANDARDS panel. Even as the technology is evolving, the focus of conversation continues to be on FDA approval and reimbursement—what will it take to get these devices into the hands of patients? As of now, we do not even have accuracy standards for episodic monitors (??! right, us too ...), and many believe that a clearly defined minimum accuracy requirement for continuous glucose monitors would clarify goals for companies working on these and expedite approval and reimbursement. The very weird thing is this: label is an important topic of this issue - and the whole question is whether the new continuous monitors should be allowed to "replace" fingersticks and thus be used to dose insulin. However, the OLD episodic monitors themselves are not labeled to dose insulin, even though everyone uses them for this purpose. This makes for very odd comparsions.

So anyway. Dr. David Klonoff, the creator of the meeting, convened a panel of thought-leaders that included clinicians, academics, math guys, industry representatives, and observers (of which we were one). The panel met on Wednesday and Thursday in a closed session chaired by Carol Herman of the FDA. The key questions that people discuss with regard to standards are a) whether the standards should be analytically-based, clinically-based, or a combination of the two (we think clinical is far more relevant); and b) whether they should begin with standards for retrospective monitoring or prospective/real-time monitoring, with the proponents of the latter believing that starting with retrospective monitoring would do little to advance the approval of continuous. The funny thing, as noted above, we do already have standards for retrospective but they aren't really complete - but who cares, let's just move forward. As of now, a subcommittee led by Dr. Anthony Furnary is set to write out a scope for the standards, which will then be drafted through CLSI, a professional standards organization. The projected time to complete standards through CLSI appears to be a staggering 22 months!

2. the Abbott NAVIGATOR. A presentation by Dr. Tim Goodnow, VP of R&D at Abbott today highlighted the progress that has been made in the past year. Of note are the improved accuracy (mean absolute relative differences now around 11-13%), longer 5-day wear period (a result not of a change in sensor chemistry but rather of improved adhesive) and 10-hour lead in required before real-time readings. . The NAVIGATOR is of course at the FDA now, along with DexCom’s STS. The Guardian RT was approved in late July. We can’t wait until we can have our very own real-time sensors – the reimbursement will likely be the toughest part of this and on that front, we’re glad to see all companies moving forward with trials – we heard the excellent GuardControl results at DT&T (an overview what was said at EASD, basically). Dr. Bruce Buckingham of Stanford said it all in his open statement to the FDA and payors, when he emphasized that the technology was usable, understandable, and dramatically improved lives, due to substantially fewer hypos. Onward! This is only going to get better …. .

3. algorithms, math, and the PSEUDO BETA CELL. This afternoon’s panel on the algorithm development for an pancreas wowed with its complexity. The task certainly is not easy, and the next step may be what’s been termed “closed loop with meal announcement,” or the semi-closed loop. This is because one major obstacle is finding a way to sync insulin release to a rise in glucose. With current monitoring technology reading approximately every one minute, it would require at least ten minutes to sense a spike upwards, and the slowness of subcutaneous insulin would amplify this lag. Studies blocking first-phase insulin release have shown that fantastic post-prandial glucose control is way off, and we know that timely insulin release is a key to glucose control, so a closed loop system will need to solve this problem.

4. early DIAGNOSIS. We were intrigued by this morning’s presentation on a non-invasive system to measure advanced glycation endproducts (AGEs), a system that could be used to diagnose type 2 patients. The current two methods we use are oral glucose tolerance tests, which are inconvenient, requiring fasting, etc., and fasting plasma glucose, which has a sensitivity of only 50%. This product, known as Scout and manufactured by VeraLight, uses Noninvasive Skin Fluorescence Spectroscopy; it is enrolling a 700-person trial now. With 6.2 million people currently undiagnosed in America, we envision this non-invasive device next to the blood pressure machine in the drugstore…and actually, beyond that, very interestingly, we are intrigued by its potential use in diagnosing complications – or possibly even helping prevent! WOW.

5. We looked on in awe yesterday as Dr. Anthony Furnary of the Starr-Wood Cardiac group in Portland presented his hospital’s stunningly low mortality rates for cardiac procedures in patients with diabetes. While diabetes patients usually have what Dr. Furnary termed the “diabetic disadvantage”—two times higher in-hospital post-operative mortality, four times higher infection rates, and longer lengths of stay—a program to tighten glycemic control in hospital has brought mortality in diabetes patients down to 0.9%, compared with the national average of 3.9% for diabetics. Dr. Furnary stressed that the most important predictor they found in the Portland diabetic project was “3BG” or the average 3-day post-operative blood glucose. To achieve those rates, they used a continuous intravenous insulin protocol and measured glucose every 30 minutes to every two hours either by arterial line drop, venous line drop, or fingerstick. This problem is mighty and these guys are powerhouses. How excellent is it that patients with diabetes actually did better, not worse, in this hospital!

The meeting's full agenda:

Agenda

Workshop A: The Business of Diabetes
Workshop B: Diabetes Technology Society International Workshop for the Establishment of Performance Standards for Continuous Glucose Monitors
Part A: Academic Perspectives
Part B: Industry Perspectives Part C: International Industry Perspectives \
Session I—Technologies for Metabolic Monitoring
Qualitative Detection of Hypoglycemia in the Central Nervous System
Session II—Artificial Pancreas
Session III—Insulin Delivery Technology
Session IV—Nanotechnology and Diabetes
Session V—Computers and Diabetes
Session VI—Annual Diabetes Technology Survey
Appendix 1 – JDRF presentation
Appendix 2 – Selected Posters