Conference Pearls

1st European Diabetes Technology and Transplantation Meeting (Montpellier, France, February 4-6, 2007)

While the rest of America was watching the Super Bowl, we were taking in the countryside in Montpellier, France, at first annual European Diabetes Technology and Transplantation Meeting. The US version, now in its seventh year, will take place in November, but in the meantime we were happy to learn what scientists in Europe and elsewhere.

• “Perfection is the enemy of the good.” This sentence was a big catch phrase at the meeting, and we think it’s an important one to remember. How to translate? As patients, we know it’s easy to become overwhelmed with the endless therapeutic goals, but it’s good to remember that while meeting or sometimes exceeding those goals is important, the big picture is more important – if you miss your target, don’t despair. Instead, work with your healthcare team on how to fix it. The same goes for technological advances: many of the speakers at this meeting argued that patients should have easier access to technologies such as continuous monitoring that can safely improve their lives, even if those technologies are not yet perfect. In other words, the standard for regulators to pass judgment on these devices should be patient outcomes and satisfaction rather than statistical indications of accuracy. We agree, though we suspect that in the US insurers won’t be as easy to convince, nor will national health payors abroad.
• Continuous glucose monitoring (CGM) is a slowly maturing technology. The more established manufacturers (Medtronic and DexCom) are working hard to improve their devices, and much work lies ahead, but to paraphrase Dr. Aaron Kowalski of JDRF, it's no longer a question of whether CGM will greatly change patients’ lives, only a question of when. We’re thrilled about Dr. Kowalski’s optimism and certainly hope he can lead the way on this front! As current users of CGM (including ourselves – see our Test Drive on DexCom’s STS) well know, there are still issues with product quality and reliability, not to mention, in the US, the absence of reimbursement from insurance companies and managed care organizations. Still, most of the participants at a CGM discussion group that we attended agreed that while the accuracy of current CGM devices isn’t perfect, it’s good enough to be useful. We agree that the area is poised for success. As Dr. Zach Bloomgarden told us in our interview, for type 1 patients with significant glycemic variability, having a continuous monitor can be nirvana.
• Unfortunately, we are not going to see a fully closed loop artificial pancreas (AP) any time soon, but so far the hybrid (semi-closed loop) algorithms seem quite promising. A fully closed loop AP would include a continuous glucose sensor, an insulin pump, and a computer algorithm that takes data from the sensor and uses it to calculate the rate of insulin infusion the patient needs from the pump—all without any actual input from the patient. A semi-closed loop AP would be similar, but patients would have to help out a little by inputting data about their meals into the device so that the algorithm doesn't get surprised by rapid blood glucose changes (it's called a hybrid algorithm because it would take data from both the glucose sensor and the patient). So far, the experiments have only been done under controlled situations so we should be skeptical, but at least in these situations the hybrid algorithms actually did better than most patients would do by themselves. We expect this technology will take a while to reach patients, and as always reimbursement from insurance companies will be a major issue, but there is an exciting base of science here.
• Non-invasive monitoring remains an area of unfulfilled expectations. We were discouraged with what we heard about the technology, though not surprised. We’ve heard that non-invasive monitoring was "just around the corner" for years, but despite over 5,000 patents issued and the dozens of companies working in this field, we’ve yet to see a reliable, convenient device and don’t expect one for some time. For now, fingersticks, and the emerging CGM devices, remain the only monitoring technologies for patients.

ADA Postgraduate Sessions (New York, NY, February 23-25, 2007)

We always love attending the ADA Postgrad meeting – an update for doctors and nurses on new practices in diabetes. In addition to the excellent lectures and workshops, we learn a great deal by talking to doctors and nurses about what has changed in diabetes management over the last 12 months. This year, nearly 1,000 healthcare professionals attended the conference, which was quite oversold. Many lectures had standing room only, testament, we believe, to the growing interest in new therapies and how to use them.

• Byetta reports from clinicians very strong. We learned that excitement continues to grow for Byetta, a new drug we wrote about in our first issue of diaTribe. It lowers A1c by about a point for most people with type 2 and prompts weight loss as well. This year’s meeting differed considerably from last year’s, in which many clinicians hadn’t heard much about Byetta (it was approved in April of 2005). Still in question is whether Byetta might actually prevent the loss of beta cells, which keeps the pancreas working, or whether it might actually cause new ones to grow. This question may not be answered for years, but it seems a possibility. To learn more about what the drug is like, see diabetes blog expert David Mendosa’s take on Byetta in this issue’s Test Drive column.
• Excitement also builds for Januvia, another new type 2 drug that we wrote about in diaTribe #2. At present, clinicians and patients are clearly enthusiastic for the drug that is taken once a day (orally!). We did hear concerns, however, about safety – this is natural with any new drug, and some doctors want to make sure no problems have surfaced for the patients taking this one. For many doctors, the clinical profile appears to have been very clean so far, though it has only been on the market since last October. Dr. Robert Ratner of Washington DC’s MedStar Clinic implied that Galvus (the other drug in this class) may be a little less “specific,” which means a little more potential for unwanted side effects. For now, the FDA has delayed approving Galvus due to monkey skin lesions seen in earlier trials at very high (about six to eight times normal) doses – we’ll be in touch on how this issue progresses.
• Increased interest in treating prediabetes. Researchers want to see Byetta tested for prediabetes, but the general expectation appears to be that Amylin Pharmaceuticals is waiting for LAR, the once-weekly version of Byetta, to test this. Experts also believe that DPP-4 inhibitors, the drug class to which Januvia and Galvus belong, should work best in early diabetes, before deterioration of pancreatic beta cells. We also heard more than one doctor say that using these drugs in prediabetic patients would make sense. We would love to see trials done. The drugs are not incredibly potent, especially at higher A1c levels, so their best use might be early in the disease or even before onset. Even then, durability, or how long they last, will become a question. We note that absolute safety is very important for a prediabetes label – a diabetes drug may not need to have perfect safety, but a preventive drug should.
• Symlin is difficult to use, but a majority of patients who use it and stay on it seem to love it. There weren’t any talks explicitly on Symlin, but the doctors who have prescribed it say that their patients relish it. It isn’t easy to prescribe, they say, but as noted in our story on Symlin in this issue, it helps produce weight loss that is greater than Byetta’s. Dr. Jack Leahy noted that patients who don’t respond as well to Byetta often actually do very well on Symlin and can lose more weight. It is said that in animal models, nothing has been more successful than Symlin, particularly in combination with other compounds. This is a kind of combination therapy that will attract significant attention in the years to come.
• Negativity on TZDs and hopes for cleaner insulin sensitizers. Actos and Avandia didn’t receive as much attention as we thought they might at this meeting – Byetta and Januvia occupied the limelight. Dr. Sidney Wolfe, Director of Public Citizen's Health Research Group, received more attention and applause than we had expected for his talk on drug safety. He noted that there have been more concerns with these compounds of late, and though he stopped short of suggesting they should not be on the market, he roundly criticized the side effect profile that includes weight gain, edema, and potential congestive heart failure.
• Direct-to-consumer advertising is growing in importance. This means advertising directly to people with type 1 and type 2 diabetes! For some time, blood glucose monitors have been advertised on TV – no surprise there, given that nearly $7 billion worth are sold every year. We expect to see even more ads in general in diabetes, and we urge you to view them carefully – they can be educational but also deceptive. Overall, though, we believe that more educational advertising should be encouraged, because the number of doctors to treat diabetes is shrinking just as the pool of patients is growing. Ads offer one way to inform, and being educated early is better than knowing later. This is one reason why we started diaTribe, and we hope you are finding it educational – to help us with a survey that gives us your thoughts on this and new products (and might give you an Amazon.com $15-off coupon in the mix) please click here!)
• Cliché as it sounds, earlier, more aggressive therapy seems to be catching on with clinicians who now have better therapeutic options. The mantra of earlier, more aggressive therapy has been invoked by the pharmaceutical industry for quite some time, but we sensed that health care providers are really getting on the wagon as well. We expect to see much more use of pharmacotherapy in the coming years for several reasons: 1) combination therapy (taking more than one drug at once) is causing patients to take more drugs, 2) patients are taking drugs longer because they’re starting earlier, and 3) there are simply more patients. Interestingly, one consequence of this may actually be later insulin therapy, which will be delayed in favor of something like Byetta. It’s an open question how long Byetta can be effective, but if its duration is significant, the lag time to insulin will increase even more.
• Anti-obesity drug rimonabant was not mentioned much. Rimonabant is a drug approved in Europe and the FDA is going to make a decision on US approval in July. We did hear Dr. Ratner point out that the weight loss with Byetta is not as good as with rimonabant. However, Byetta’s weight loss is also progressive, which means you continue to lose over time, while rimonabant’s looks from trials to be a fixed drop.
• Continuous monitoring (CGM) and pumps received little attention. And for type 1 patients, lest you thought you’d never hear anything…we can tell you on pumps, many doctors haven’t yet heard of the new disposable pump company, Insulet (www.insulet.com), even though Insulet has more than 1,000 patients. We plan to do a Test Drive in the next couple of issues. On CGM, we’re looking forward to the next generation of devices and for Abbott’s Navigator to be approved. With CGM, as with home glucose monitoring a few decades ago, industry will have to do a lot of work to achieve reimbursement for this technology, though we do hear a few anecdotes of private insurers paying for it. If you think you would benefit from continuous monitoring, here are some reimbursement tips - see Amy Tenderich’s blog at DiabetesMine.com.