Dexcom and Roche Announce Partnerships for Future-Generation Integrated Pump-CGM Systems, Selling Dexcom Seven Plus to Physicians for Short-Term Use With Their Patients
Self-monitoring of blood glucose (SMBG, i.e., fingersticks) and continuous glucose monitoring (CGM, i.e., wearing a sensor) sometimes seem like rival technologies in the world of diabetes management. However, that is not exactly true: people using CGM still take fingerstick measurements to calibrate the sensor and to confirm its accuracy when dosing insulin. The SMBG-CGM ‘rivalry’ is not necessarily true at a commercial level, either, as we saw in two recent partnerships between Roche (maker of Accu-Chek blood glucose meters and Accu-Chek pumps) and Dexcom (maker of the Seven Plus CGM system). One deal is about developing a handheld device that will communicate with Dexcom’s next generation CGM sensor and two different Roche pumps; one is about encouraging physicians to prescribe short-term “diagnostic” use of the Seven Plus, and both are detailed below.
one handheld, three devices
Under a new research and development (R&D) agreement, Dexcom will help Roche develop a new handheld insulin-pump controller that also acts as a receiver for Dexcom’s fifth-generation sensor (note that the current Dexcom Seven Plus in the US is the third generation sensor). Interestingly, this CGM-integrated handheld will be able to operate two different kinds of Roche pumps: one that uses infusion sets (Roche’s traditional pump technology), and one that does not (i.e., a “patch” pump, Roche’s Solo technology). We anticipate that the former will be a new generation of the Accu-Chek Combo, which is an Accu-Chek Spirit pump integrated with an Aviva blood glucose meter. The Combo is available internationally and is currently under FDA review. As for the patch pump, we think it will be the Solo MicroPump, a sophisticated device that Roche has been developing since it acquired Medingo in 2010 (see NewNowNext in diaTribe #17 and NewNowNext in diaTribe #23). We think that probably only a few patients would own both pumps and switch off according to their activity schedules, unless Roche offers some sort of two-for-one deal. However, for patients who decide to permanently switch from a traditional Accu-Chek pump to the Solo (or vice versa), having the same handheld should make the transition much easier.
the partners’ pipelines
As a reminder, a first-generation version of the Solo was cleared by the FDA in 2009 but has never been commercialized. Earlier this year Roche explained that it would delay launch until the company has finalized (and received FDA clearance for) a second-generation Solo with a blood glucose meter built into the handheld. We aren’t sure if the company still plans to go straight to market once it has regulatory approval for this BGM-integrated Solo; Roche has implied that worldwide launch would come no earlier than 2013, a year delay from the 2012 expected launch. With this new partnership, Roche might wait to launch the Solo until development of the controller that also has CGM – if rival patch pump Insulet has an integrated handheld with CGM, this is definitely a good idea. Either way, Dexcom and Roche plan to submit the CGM-integrated handheld to the FDA before the end of 2013 as we understand it. In the meantime, Dexcom is working on its new fourth-generation system, which could be launched as soon as late 2012 or in 2013.
integration now and tomorrow
This Roche partnership marks Dexcom’s third R&D agreement with a major pump manufacturer. Dexcom is also collaborating with Animas to develop the Animas Vibe (currently available in some European countries, with a potential US approval sometime in early 2013 at the earliest; see Conference Pearls in diaTribe #30 for background on the system), and it is also working with Insulet to develop a combination of the second-generation OmniPod and Dexcom’s fourth-generation sensor (now on a similar timeline to the Animas Vibe, which represents a delay from the timeline that had been established until recently (see NewNowNext of diaTribe #36). However, the Roche agreement is the first time we’ve heard about an integrated pump-CGM product that will use Dexcom’s fifth-generation system – something of a milestone, as the fifth-gen will have its data-processing “brains” in the CGM transmitter rather than the receiver. This means that the fifth-gen’s wireless signals could theoretically be displayed by a variety of devices, like a hospital monitor or even a smart phone. Pairing medical devices with smart phones still appears to be a sensitive issue for the FDA, so it might be many years before people are flipping between texting and tracking their glucose on the same screen. Fortunately, in the nearer term, the new generations of integrated diabetes technologies are getting only sleeker and user-friendlier, so we can’t wait to see the cutting-edge design that Roche and Dexcom have in store.
In another new agreement, Roche will begin selling Dexcom Seven Plus CGM systems to physicians, who can then make the systems available to patients for short-term use. Roche sales representatives will have financial incentives to sell Dexcom’s CGM. Additionally, Medtronic also had news on the short-term CGM front this month, announcing FDA approval of the iPro2. This is the newest version of Medtronic’s iPro CGM, which healthcare professionals can temporarily prescribe to patients to get a better idea of their glycemic control. We think both news items have the potential to benefit type 2 patients in particular, who can better assess with their doctor the progression of type 2 diabetes. For those patients (as well as for type 1 patients who don’t yet wear CGM), a short-term CGM stint should also help them get a better sense of their glucose patterns and how they can improve their diabetes management. Doctors have long been criticized for “inertia” in moving patients to more optimal therapies and we believe just a week or two of CGM use should surely point out what is working and what isn’t. For other patients – those who have been wanting to try CGM, those who tried earlier versions of CGM and have been waiting for improvements, or those who have never even heard of continuous monitoring – short-term CGM use could be a segue into long-term adoption. –JPS