2009: Year in Review (Continued)
- And that's not all on diabetes technology! We've heard about very interesting new pumps from a range of companies including Calibra (more a wearable pen as we understand it), Cellnovo, Tandem Diabetes, and Valeritas – we'll see what the future holds, but we're very excited. On the blood glucose monitoring front, look for a new integrated system from Intuity Medical, that lets you lance and test and see your score all in the same few seconds, and without carrying around a lot of material. New meters are also coming from LifeScan and Roche and Abbott, and potentially new CGM as well, though probably none of those will make the market as early as 2010.
- Obesity drugs: We expect to hear from the FDA on three obesity drugs in 2010: Qnexa, Lorcaserin, and Contrave. The question is: which one will be the biggest winner? Lorcaserin has impressive safety and side effect profiles, Qnexa recently released very robust weight loss results, and Contrave has a compelling mechanism of action and uses two pharmaceutical compounds with 20 years of use in the US. At conferences, we often hear physicians express their hopes that these new, better obesity drugs will work synergistically with the most important and historically most challenging aspects of weight management: diet and exercise and diabetes.
- Exenatide Once Weekly: Amylin and Eli Lilly submitted the NDA for Exenatide Once Weekly mid-2009, and the FDA should respond this spring. This is one drug that we've been following closely, and it could be a complete game-changer when approved.
- Blood glucose changes ahead – better accuracy: Though it hasn't happened yet, we believe the FDA will mandate making blood glucose monitors more accurate – currently, monitors must be within 20% of a lab standard, and we believe this will move to 10-15%. We see better accuracy as a positive and also believe that other simple things must be stressed, like making sure hands are washed, etc., to reduce the risk of "off" scores. In the hospital, better accuracy is very important – we look, in 2010, to start to see continuous glucose monitoring used in the hospital, with DexCom and Edward's inpatient continuous glucose monitor, so if you or your loved ones wind up in the hospital, be sure to ask for this.
- Faster insulin? Biodel has submitted its "faster" insulin to FDA, and we look for news on this late in 2010 – we believe faster insulin is a significant patient need, and we would like to see more progress on this front.
- Inhaled insulin – again? A company called MannKind, run by Al Mann, the insulin pump and pacemaker pioneer, has submitted a drug to FDA called Afresa that addresses many of the shortcomings of the first generation inhaled insulin that did so poorly commercially. We are very interested to see what happens – we think the improvements are quite impressive, and we still believe many insulin alternatives are needed – 47% of people with diabetes in the U.S. are not at their glycemic targets (meaning 7% A1C, not even 6.5%, which is the "real" target for many) and just 27% are on insulin. Too, when we survey healthcare providers, there are few innovations they want more than faster insulin – this is very important for patients today and for progress on the closed loop.
- We look for new research and findings from many new classes of diabetes drugs, including SGLT-2 inhibitors (a pill for both type 2 and possibly eventually type 1 patients), GKA (glucokinase activators), and new insulins (some will last longer and some will be faster and some may even be "glucose-dependent," meaning they would be associated with much less hypoglycemia).
This year in particular we want to extend our appreciation to researchers for working to make life better for people with diabetes. At Close Concerns and diaTribe, we love our work and are grateful for the progress we witness nearly every day. Please know, scientists, that a growing number of people around the world are relying on you, and with hope and humility, they have faith in your efforts. As always in diabetes, hope and frustration are constant companions, but a New Year is always the time to celebrate the achievements, honor the sacrifices, and dream of the breakthroughs of tomorrow. Cheers, all around…
Nick Wilkie and Kelly Close work at Close Concerns, a healthcare information firm devoted exclusively to diabetes and obesity. They help publish a monthly newsletter called diaTribe, an independent, advertising-free e-newsletter for everyone eager to learn about the latest advances in diabetes management. diaTribe is your inside track on diabetes research and products – – sign up here for your complimentary lifetime subscription.
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Years before I was diagnosed with type 2 diabetes, The Other Half came out of a doctor's appointment with a diagnosis of "borderline diabetes" and an ADA exchange diet sheet. His health insurance agency followed up on the diagnosis with a glucometer and test strips. After a year or so of trying to follow the diet plan and test his glucose levels, things appeared to be back in "normal" range, and stood there until a couple of years after my own diagnosis. Shortly...