It was a good year for breaking new ground, too. Roche launched Accu-Chek Aviva Expert<\/a> \u2013 the first blood glucose meter to track insulin on board and include a bolus dose calculator (especially useful for MDI patients), and Tidepool<\/a>, 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.<\/p>\n Looking ahead to 2015, we\u2019re optimistic about these seven diabetes products potentially hitting the market in the next 12 months.<\/strong><\/p>\n In their 2014 2nd<\/sup> Quarter call in late July, Tandem\u2019s President and Chief Executive Officer Kim Blickenstaff announced that Tandem had submitted a PMA application to the FDA for the t:slim G4\u2122 Insulin Pump, which integrates t:slim pump technology with the Dexcom\u00ae G4\u00ae Platinum CGM System.<\/p>\n 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\u2019s reasonable to predict that we could see its release in mid-to-late 2015.<\/p>\n 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<\/a>.<\/p>\n According to Sayer, Dexcom G5 will be the same manufacturing process as G4, so this will not be an update of their sensor<\/em> technology, per se, but the user interface and the transmitter will have a new look with new connectivity capability \u2013 namely a Bluetooth-enabled transmitter and a smartphone interface to be released first on the iOS platform.<\/p>\n \u201cIt will talk directly to a cell phone and another device\u201d, says Sayer. \u201cSo 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.\u201d<\/p>\n On the heels of G5 approval, we should expect to see submissions from Asante and Insulet, both of whom announced intentions<\/a> in 2014 for partnership with Dexcom<\/a> for G5-integrated products, showcasing prototypes<\/a> at AADE 2014 (Asante) and expected to showcase<\/a> at ADA 2015 (Insulet). We could potentially see two new integrated pumps on the market in early 2016, bringing the total to FIVE!<\/p>\n 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.<\/p>\n 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\u2019s 3mL Humalog pen cartridges and the two insulin cartridges are differently shaped.<\/p>\n For insulin pumpers in Europe, you may see Medtronic Minimed\u2019s 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 <\/em>LGS capabilities (called SmartGuard) and be able to suspend and resume basal delivery based on predicted hypos, performing as a semi-automatic closed loop.<\/p>\n Sneak peaks of 640G reveal that the Medtronic<\/a> design is in for a long-awaited facelift with a color screen, portrait orientation, new buttons, and a whole new user interface.<\/p>\n The big product buzz in 2014 had to be the FDA hearing<\/a> and subsequent approval<\/a> of Mannkind\u2019s inhalable insulin Afrezza. We ruminated on<\/a> its timeline this time last year, but with approval and announced partnership<\/a> with Sanofi, they are anticipating a US launch in early 2015.<\/p>\n 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.<\/p>\n 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<\/a> (New Drug Application) in July 2014. Once approved, it will be the first U300 insulin on the market anywhere in the world.<\/p>\n Why should we follow the development of this insulin? According to the results<\/a> 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.<\/p>\n No, not that one. This<\/em> one.<\/a> 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 \u201csteady stream of product innovations\u201d to which CEO Terry Gregg alluded to in their Q3 earnings call<\/a>, wherein he referred to the newly launched Dexcom Share<\/a> as \u201ca pressure test for all the infrastructure we\u2019ve been building for a long time to manage this data remotely.\u201d<\/p>\n 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\u2026 or a lesson learned in who really owns our data. Let\u2019s hope for the former.<\/p>\nTandem t:slim G4 Insulin Pump<\/strong><\/h2>\n
![\"Tandem](\"https:\/\/asweetlife.org\/wp-content\/uploads\/2014\/12\/tslim-G4-.png\")
<\/a><\/p>\nDexcom G5 Continuous Glucose Monitoring System<\/strong><\/h2>\n
![\"Dexcom_One_Step_Ahead\"](\"https:\/\/asweetlife.org\/wp-content\/uploads\/2014\/12\/Dexcom_One_Step_Ahead-300x95.jpg\")
<\/a><\/p>\nAsante Snap Insulin Pump \u2013 Novolog Compatibility and Pediatric Indication<\/strong><\/h2>\n
![\"Asante's](\"https:\/\/asweetlife.org\/wp-content\/uploads\/2014\/12\/Asantes-New-Snap-Insulin-Pump.jpg\")
<\/a><\/p>\nMedtronic 640G with SmartGuard<\/strong><\/h2>\n
![\"Medtronic](\"https:\/\/asweetlife.org\/wp-content\/uploads\/2014\/12\/Medtronic-640G.jpg\")
<\/a><\/p>\nAfrezza Inhalable Short-acting Insulin<\/strong><\/h2>\n
![\"Afrezza](\"https:\/\/asweetlife.org\/wp-content\/uploads\/2014\/12\/AFREZZA1.jpg\")
<\/a><\/p>\nToujeo Basal Insulin<\/strong><\/h2>\n
Dexcom G4 Platinum with Share?<\/strong><\/h2>\n
![\"Dexcom](\"https:\/\/asweetlife.org\/wp-content\/uploads\/2014\/12\/Dexcom-Share.png\")
<\/a><\/p>\n