This year has seen some exciting new developments from the diabetes industry, particularly for continuous glucose monitoring. In February, Dexcom’s G4 Platinum CGM was approved for pediatric indication and then, in November, they released their Software 505 update to the G4 Platinum (non-pediatric) receiver with an advanced algorithm being used in artificial pancreas research around the world. Also in November, J&J Animas finally received US FDA approval of their Animas Vibe Dexcom-integrated insulin pump that has been available in Europe since 2011 and will start shipping in January 2015. Another player in the CGM business, Abbott Diabetes, received the CE Mark for their new FreeStyle Libre Flash Glucose Monitoring system in 2014.
It was a good year for breaking new ground, too. Roche launched Accu-Chek Aviva Expert – the first blood glucose meter to track insulin on board and include a bolus dose calculator (especially useful for MDI patients), and Tidepool, the non-profit champion of open source data headed by Howard Look, announced that Asante, Dexcom, Insulet, Abbott, and Tandem had all come on board to open data partnerships.
Looking ahead to 2015, we’re optimistic about these seven diabetes products potentially hitting the market in the next 12 months.
Tandem t:slim G4 Insulin Pump
In their 2014 2nd Quarter call in late July, Tandem’s President and Chief Executive Officer Kim Blickenstaff announced that Tandem had submitted a PMA application to the FDA for the t:slim G4™ Insulin Pump, which integrates t:slim pump technology with the Dexcom® G4® Platinum CGM System.
The t:slim G4 will provide a strong competitor to Animas Vibe and Medtronic 530G in the US pump market and raise the stakes for the remaining pump providers (Roche, Asante, Insulet) to deliver on CGM integration. It’s reasonable to predict that we could see its release in mid-to-late 2015.
Dexcom G5 Continuous Glucose Monitoring System
Dexcom continues their forward momentum with expected first quarter 2015 FDA submission of their G5 technology, said Dexcom President and Chief Operating Officer Kevin Sayer in their second quarter earnings call.
According to Sayer, Dexcom G5 will be the same manufacturing process as G4, so this will not be an update of their sensor technology, per se, but the user interface and the transmitter will have a new look with new connectivity capability – namely a Bluetooth-enabled transmitter and a smartphone interface to be released first on the iOS platform.
“It will talk directly to a cell phone and another device”, says Sayer. “So you can have two devices that receive a signal from that transmitter. And we will offer the patients a receiver that receives a Bluetooth signal as well, so they have a backup in case their phone battery goes dead.”
On the heels of G5 approval, we should expect to see submissions from Asante and Insulet, both of whom announced intentions in 2014 for partnership with Dexcom for G5-integrated products, showcasing prototypes at AADE 2014 (Asante) and expected to showcase at ADA 2015 (Insulet). We could potentially see two new integrated pumps on the market in early 2016, bringing the total to FIVE!
Asante Snap Insulin Pump – Novolog Compatibility and Pediatric Indication
Speaking of newcomer Asante Solutions, having launched their newest version of Snap with an updated, customizable look and color LCD screen at the end of 2014, they are setting their sites on making their pump available to more users.
Next year, we will see Asante submit to FDA for a pediatric indication for users 10 years and older, as well as for a Novolog indication. The latter has required them to develop a Novolog-specific disposable pump body because their current design is tailored to the specs of Lilly’s 3mL Humalog pen cartridges and the two insulin cartridges are differently shaped.
Medtronic 640G with SmartGuard
For insulin pumpers in Europe, you may see Medtronic Minimed’s newest offering launched as early as April 2015. Taking their Low Glucose Suspend feature to a new level and using a second generation Enlite sensor, 640G will have predictive LGS capabilities (called SmartGuard) and be able to suspend and resume basal delivery based on predicted hypos, performing as a semi-automatic closed loop.
Sneak peaks of 640G reveal that the Medtronic design is in for a long-awaited facelift with a color screen, portrait orientation, new buttons, and a whole new user interface.
Afrezza Inhalable Short-acting Insulin
The big product buzz in 2014 had to be the FDA hearing and subsequent approval of Mannkind’s inhalable insulin Afrezza. We ruminated on its timeline this time last year, but with approval and announced partnership with Sanofi, they are anticipating a US launch in early 2015.
Afrezza will be a complimentary therapy for both type 1s and type 2s on insulin. It would be used in conjunction with traditional basal insulin (and/or traditional antidiabetic drugs in type 2 patients) as a meal-time insulin delivered in small set inhalable doses.
Toujeo Basal Insulin
Another possible new offering from Sanofi is their investigational U300 basal insulin Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL). FDA accepted their NDA (New Drug Application) in July 2014. Once approved, it will be the first U300 insulin on the market anywhere in the world.
Why should we follow the development of this insulin? According to the results from late-stage trials in people with type 2 diabetes, Toujeo showed up to a 31% reduction in nocturnal hypoglycemia compared to their popular basal insulin Lantus, whose patent expires this year. With the same active ingredient as Lantus, Toujeo will have a flatter profile, a longer duration of action (which will help account for the problematic half-life of Lantus which results in the need for some patients to split doses), and could mean fewer injections and therefore improved adherence from patients.
Dexcom G4 Platinum with Share?
No, not that one. This one. Is there a Share-integrated G4 receiver in our future? Details are non-existent (schematics and other sensitive data are protected from public consumption), but there is certainly a filing with FCC that makes us speculate. Perhaps this is part of the “steady stream of product innovations” to which CEO Terry Gregg alluded to in their Q3 earnings call, wherein he referred to the newly launched Dexcom Share as “a pressure test for all the infrastructure we’ve been building for a long time to manage this data remotely.”
Those of us watching the rise of CGM as it relates to pump integration and data mobility are watching to see how successfully these device companies can maneuver through regulatory and functional hurdles for mobile software. 2015 may well be the start of a new era of connectivity… or a lesson learned in who really owns our data. Let’s hope for the former.
Melissa Lee writes the blog Sweetly Voiced.