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Kelly thanks the FDA for keeping its holiday promise: an artificial pancreas guidance document by December 1

We at diaTribe are grateful for quite a bit this Thanksgiving – several new diabetes devices and a couple of diabetes drugs approved1 by the FDA in recent months (and more by global regulatory authorities), the FDA coming in ON TIME (today!) with their advice for researchers and scientists and others developing the artificial pancreas, a grand World Diabetes Day celebration in San Francisco and around the world, and a greatdiaTribe family of writers, editors, and (most importantly) readers. A few more details on the newest news - as you might have heard, the FDA previously committed to release a draft guidance document on the artificial pancreas – a way to sync up an insulin pump with a continuous glucose-monitor for automatic glucose control – by December 1. Essentially, this draft guidance will tell companies and researchers what sorts of standards an artificial pancreas would need to meet in order to gain approval. Doctors, scientists, educators, advocacy groups, and patients were understandably eager to make suggestions to the FDA (and to encourage the agency to meet its self-established deadline), as we describe in this issue’s New Now Next. We were very excited (and thankful!) to wake up today and see that all this pressure pushed the agency to come through and release the guidance document on December 1, as promised. Opinions about the document will likely emerge in the coming weeks, but in a conversation with Dr. Aaron Kowalski this afternoon, we learned that JDRF is encouraged after their initial review. Kudos to the nonprofit for so much work on behalf of so many patients.

We’re especially excited to see the FDA’s guidance after we got hands-on looks at the newest artificial pancreas prototypes during this year’s Diabetes Technology Meeting. Starting in late October, volunteers in Europe have been trying out an artificial pancreas system that uses the technology of today: an Android cell phone, an insulin pump, and a CGM. Notably, the test occurred outside the hospital and included a day of active travel and full-blown restaurant meals. Here in the US, the FDA has recently given the go-ahead for several key studies on precursors to the artificial pancreas (including one for Medtronic’s “low glucose suspend” pump/CGM device, which can turn off insulin delivery when it measures glucose as being too low). Given these positive signs in the past few weeks, it’s only a slight exaggeration to say we were holding our breath until early December hit – happy news, all around. The devil is in the details, though, so we’ll want to keep close watch on development of the AP to make sure it really does start moving more quickly. Thanks especially to Pam Kagen, longtime JDRF supporter and parent for her excellent talk to Congress that launched so much interest of late…

Of course, it will still be several years until even hybrid “closed-loop” systems come to market, and even then diabetes management will remain a complex job that demands daily (and often hourly and sometimes minute-to-minute) focus. The upside is that companies have been putting a priority on making their devices and drugs as simple to use as possible – some very simple products, of course, have been some of the most successful ones commercially (just a few examples include fast and portable blood glucose meters, statins, Lantus, Januvia, Dexcom’s Seven Plus).

While ease-of-use is not exactly a new idea conceptually, in this issue of diaTribe we discuss some recent breakthroughs on this front. For example, the FDA has approved Tandem’s t:slim insulin pump, which features a touchscreen and the sort of intuitive user interface that you’d expect from a top-line smartphone. Things are also happening on the drug side, as Sanofi is ramping up development of a next-generation version of Lantus. And the FDA has a lot on its plate in early 2012, including whether to approve a slew of new medicines that all have promise to make life easier for patients, including Bydureondapagliflozin, and Qnexa, all in the first part of the year – all are novel and widely characterized as much easier to take for patients – and degludec insulin later in the year.

Simplicity is also the goal for Glooko, a new IT/social media diabetes company that seeks to remove some hassle out of downloading data from a blood glucose meter. Glooko’s system consists of a cord that quickly uploads data from any of six widely used meters to the Apple iPhone, iPad, and iPod touch. Once the data are on the devices, users can view it, make notes, and send summaries to their healthcare providers or families with a new app called Glooko Logbook. To do our part spreading the latest technologies (and to hear your thoughts about diabetes management on the web), we’re giving away free Glooko MeterSync Cables to the first 50 people who take a quick survey (see this month’s New Now Next.) With that, onward – and thank you, as always, for your readership.

Yours,

Kelly L. Close


1 FDA approvals in the last half year include: Medtronic’s updated CareLink personal software and Onglyza for those with kidney problems (see NewNowNext in diaTribe #32); BI/Lilly’s DPP-4 inhibitor Tradjenta, Asante’s Pearl insulin pump, and Spring’s Universal Infusion set (see NewNowNext in diaTribe #33); Telcare’s cellular-enabled blood glucose meter (see New Now Next in diaTribe #35); Lifescan’s Verio test strips (see New Now Next in diaTribe #36); use of Byetta alongside Lantus (see New Now Next in diaTribe #37); and Tandem’s t:slim insulin pump (see New Now Next in diaTribe #38). There were no novel drug approvals in the past half year, but multiple novel drugs delayed, including Bydureon and dapagliflozin (see New Now Next in diaTribe #35); and weight loss medications Qnexa and Contrave (see New Now Next in diaTribe #36).

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