This year has witnessed some new developments in the diabetes industry, particularly for continuous glucose monitoring.In February Dexcom G4 Platinum CGM was approved for its pediatric indication and then, in November, which launched its 505 software update to the G4 Platinum receiver (non -pediatric) with an advanced algorithm used in artificial pancreas research throughout the world.Also in November, J & AMP;J Animas finally received approval from the FDA of his integrated insulin bomb Dexcom Animas Vibe that has been available in Europe since 2011 and will begin to be distributed in January 2015. Another of the CGM business players, Abbott Diabetes, received the CE brandfor its new free freestyle flash glucose monitoring system in 2014.
It was a good year to open new roads, too.Roche launched Acu -Chek Aviva Expert - the first blood glucose meter to track insulin and includes a bolus dose calculator (especially useful for IMD patients), and Tidepool, the non -profit champion of profit data from data fromOpen source headed by Howard Look, announced that Asante, Dexcom, Insulet, Abbott, and Tandem had all reached an agreement to open data standards.
Facing 2015, we are optimistic about these seven diabetes products to potentially get to the market in the next 12 months.
tandem T: Slim G4 Insulin Bomb
At the end of July 2014, the president of Tandem and CEO Kim Blickestoff announced that Tandem had submitted a PMA request to the FDA for the T: Insulina Pump ™ Slim G4, which integrates T: thin pump technology with the Dexcom® G4® Platinum CGM system.
The T: Slim G4 will provide a strong competitor for Animas Vibe and Medtronic 530g in the US bomb market and raise bets for the remaining bomb suppliers (Roche, Asante, Insulet) to deliver in the CGM integration.It is reasonable to predict that we could see its launch in the middle and end of 2015.
Dexcom G5 Continuous glucose monitoring system
Dexcom continues its impulse forward with the expected result first quarter 2015 the presentation of the FDA of its G5 technology, said President Dexcom and operations director Kevin Sayer in his second quarterly gain report.
According to Sayer, Dexcom G5 will be the same manufacturing process as G4, so this will not be an update of its sensor technology, in itself, but the user interface and the transmitter will have a new appearance with a new connectivity capacity- Namely, a Bluetooth Transmitter enabled and a smartphone interface that first launched on the iOS platform.
"It's going to speak directly to a cell phone and another device," says Sayer."So you can have two devices that receive a sign that the transmitter. And we are going to offer patients a receiver that receives a bluetooth signal, so, they have a backup in case your phone batteryIt is exhausted. "
In the G5 approval heels, we will have to wait to see the presentations of Asante and Insulet, who announced intentions in 2014 by association with DEXCOM for G5-integrated products, showing prototypes in AADE 2014 (Asante) and it is expected that in a showcase ofADA 2015 (Insulet).Potentially we could see two new pumps integrated in the market in early 2016, reaching a total of five!
Insulin Pump New Snap of Asante
Speaking of newcomers Asante Solutions, having launched its new version of Snap with an LCD screen of customizable appearance and color updated at the end of 2014, which are giving their sites in the manufacture of their pump within reach of more users.
HeYear that comes, we are going to see Asante to present the FDA for a pediatric indication of users over 10 years, as well as for a Novolog indication.The latter has required them to develop a specific Novolog Pump body because its current design fits the specifications of the 3 ml cartridges Humalog feather of Lilly and the two insulin cartridges have a different shape.
Medtronic 640g with smartguard
For insulin pumps in Europe, you can see the most recent offer of Medtronic Minimed already launched in April 2015. Taking its low glucose characteristic of suspension at a new level and the use of a second generation list sensor, 640g will have LGS predictive capabilities (called smartguard) and be able to suspend and resume basal delivery based on predicted hypoglycemia, acting as a closed semi -automatic loop.
Straight 640G peaks reveal that Medtronic design is in a highly anticipated face wash with a color screen, vertical orientation, new buttons, and a new user interface.
Insulina Achable Action Action Short
The buzzing large product in 2014 had to be the FDA audience and the subsequent approval of the inhalable insulin of Mannkind Aphrezza.We are rumped in its timeline this time last year, but with approval and we announce collaboration with Sanofi, which are anticipating a launch in the United States in early 2015.
AFREZZA will be a complementary therapy for the 1s and 2s type of insulin type.It would be used in conjunction with traditional basal insulin (and / or traditional antidiabetic drugs in type 2 patients) as an insulin for the moment of food delivered in small inhalable doses established.
Toujeo basal insulin
Another possible new offer of Sanofi is its (insulin injection Glargina [DNR origin], 300 U / ml) in basal insulin research U300 toujeo.FDA accepted its NDA (New Drug Application) in July 2014. Once approved, it will be the first U300 insulin in the market anywhere in the world.
Why should we follow the development of this insulin?According to the results of the late stage tests in people with type 2 diabetes, Toujeo showed a reduction of up to 31% in night hypoglycemia compared to popular basal insulin Popular 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 to account the half -life of Lantus problems that translates into the need for some patients to divide the doses),and could mean less injections and, therefore, greater adhesion of patients.
Dexcom G4 Platinum with Share
No, it's not that.This.Is there a G4 G4 sharing integrated in our future?The details are non -existent (schemes and other sensitive data are protected from public consumption), but without a doubt there is a presentation to the FCC that makes us speculate.Perhaps this is part of the "constant flow of product innovations" to which the CEO Terry Gregg alludes to its Q3 earnings report, in which it referred to the newly released Dexcom sharing as "a pressure test of the entire infrastructurethat we have been building for a long time to manage this data remotely. "
Those of us see the output of CGM which refers to the data integration and mobility pump are attentive to see how these device companies successfully can maneuver through regulatory and functional obstacles for mobile software.2015 may well be the beginning of a new era of connectivity ... or a lesson lesson in which you really own our data.Hopefully for the first.
