After disclosing last quarter that coronavirus-driven delays of at least six months will affect pivotal studies of its G7 device, CEO Kevin Sayer told investors Tuesday it will forgo an end of 2020 soft launch and wait to roll it out until the company has the capacity to fully transition G6 users to the … Abbott has applied for iCGM classification for its Libre 2 CGM , but the agency has yet to render a decision on that device. 7 Not based on head-to-head study. Once you receive your new DASH™ PDM, visit the App Store, download the apps and get started! September 9, 2019 08:00 AM PDT Dexcom G6® CGM System Now Available In Canada It was also reported that the more someone engaged with Dexcom G6 features, the better their Time in Range, including 38% less time spent with low BGs. Sayer said design of G7 is complete and access to clinics has reopened, but was tightlipped on other fronts. Tandem will be rolling it out starting in mid-January 2020, along with a new mobile app that will enable auto-uploads of diabetes device data to its t:connect web platform. In an earnings call in August 2019, BD announced it had withdrawn its FDA application for this product, but then-CEO Victor Forlenza (who was replaced in Sept. 2019) still emphasized that BD was working on it with a third-party R&D partner and “remained committed” to the patch pump. We’re told that new features for that mobile app will be gradually unveiled starting in mid-2020, including data display and integration of other health data; eventually, they will offer full mobile phone control of the t:slim X2 insulin pump via the app! ... Shares of Intel have fallen more than 21% year to date, making it one of the worst-performing stocks in the Dow. Hello, BluHale! The recently approved Dexcom G6 Continuous Glucose Monitor is expected to launch into the Australian market in June, once stock hits our shores. Beta Bionics iLet: Many are excited about the “FDA breakthrough device designation” received by this closed loop tech company in December 2019, but we’re still at least a year or two away from seeing this product ready for launch. Note: If no date is supplied, the release date will be set to 45 calendar days past the date of grant. At our recent DiabetesMine University event in November, CEO Jeffrey Brewer put a 2021 timeline on the first-gen Unity product with a next-gen version the following year. And so, we’re going to make sure everyone has access at launch. Ultra-Rapid Lispro Insulin (uRLi): This is a new even-faster acting mealtime insulin. While we don’t expect to see this launched in 2020, we do expect to hear updates on development and early trials. “I am not going to provide you a specific clinical trial, filing and launch dates today,” Sayer told analysts, adding, “we have no interest in sharing our playbook with the entire industry.”. Type NA. Eventually, this will work with the Dexcom CGM (continuous glucose monitor), as the two companies just signed an agreement to that end. Though more recently, we’re hearing Bigfoot plans to file the Unity pen-version in late 2020 with a possible launch slated for end of the year, so we shall see. That Type 2 penetration is still low compared to Dexcom's primary CGM rival Abbott, where Type 2 users account for about half of all business, as cited in a note from analysts at Stifel late Tuesday. Medtronic says they’ve already submitted the BLE-connected component of that device to the FDA. We’ve heard the holdup has been the FDA considering whether to grant this device the new “iCGM” designation, that would deem it officially interoperable with other such devices, like the Tandem t:slim X2. The much-anticipated auto-injector version contains a 6mm needle, but you’ll never see the needle, as the pen is self-contained for quick one-time use and disposal. Notably, it would be the first patch pump style option beyond Omnipod and includes a side-button for a quick insulin dose from the device itself. The t:sport will have a stick-to-your-body adhesive part on the back, but would detach and also the t:slim’s trademark pigtail insulin tubing that attaches to the infusion set for insulin delivery. The Keys are automatically updated daily. “I am not going to provide you a specific clinical trial, filing and launch dates today,” Sayer told analysts, adding, “we have no interest in sharing our playbook with the entire industry.”. But due out 2021. JDRF has launched T1Detect, the first-ever home screening kit for risk of type 1 diabetes. Lilly submitted URLi to regulators in the US as well as Europe and Japan during 2019, and the Pharma giant is expecting regulatory approval in all three markets in 2020. Blackford told analysts spending will rise significantly in the second half of the year, about $100 million more, not just from advertising costs but from resources toward G7 studies, for which the company is currently finalizing locations and timing both in the U.S. and internationally. While details are still scant, Dexcom’s hinted at some big revisions to what the G7 will offer: Extended Wear of 14-15 days: This adds four to five additional days compared to the current 10-day wear of the Dexcom G6. Now that Control-IQ is approved and being launched, Tandem is pushing forward on filing the t:sport for FDA review in mid-2020. The California company has been increasing its production capacity for the past year with G6, and says it’s paving the way for a smooth launch of its next-gen product. It also aims to achieve 80% user Time in Range compared to the existing 71% TIR shown in data on the 670G. This means users only need to have it implanted and replaced every six months, compared to every three months as is currently the case. Differences between the Dexcom G6 and G7. Diabetes Tech Updates: May 2020. DiabetesMine has the back story on artificial pancreas technology development -- everything you need to know. Here’s a roundup of what we expect to see materialize in diabetes technology in 2020, with some of our own insights and observations sprinkled in: Control-IQ: FDA approval of this new tech from Tandem was the big end-of-year story for 2019. Plus, a look ahead to the smaller G7. Dexcom G6 CGM User Guide. U.S. clinical studies and overseas launch are expected in 2020, and WaveForm tells us they’re planning for a 2021 launch here in the States. Our team at the ‘Mine has been listening to industry earnings calls, talking with company insiders, and generally “reading the tea leaves” about what’s on the horizon. Back; Setting up Xdrip onto a Android Watch; Getting Started with Xdrip; Xdrip Compatible Watches ; Xdrip Compatible … It will provide automatic correction bolusing, will automatically adjust for missed meals, and allow an adjustable glucose target down to 100 mg/dL (compared to the 670G’s set target at 120 mg/dL). Eventually, you should say a type 1 version, a type 2 version, and a hospital version, says … Insulet says it expects to file mid-year, with a hopeful approval and limited launch by end of 2020 and a full commercial launch in 2021. We’re expecting an insulin-only version to be available before we eventually get to the dual-hormone version with both insulin and glucagon inside the pump. Second quarter sales approached $452 million, or around $35 million ahead of analyst expectations. Longer Wear: We’re waiting on word about U.S. availability of a longer-wear 180-day sensor (available outside the USA as Eversense XL). The company says it’s working closely with the FDA to determine regulatory requirements for additional components of the platform, including the attachment that will transmit insulin dosing data from the pen to a mobile app. The company is targeting its next generation transmitter, the G6, for a Q3 2017 FDA submission and a 2018 launch. See the 2019 DiabetesMine University preview of Beta Bionics system here. How do you stay positive and confident? As with the G6, no fingerstick calibrations will be required. FreeStyle Libre 2 system will be list priced the same rate as FreeStyle Libre … CFO Quentin Blackford described near-term plans on that front as “turning on the DTC spigot for the first time in a significant way. 8 FreeStyle Libre 2 system user manual. Dexcom hasn’t yet filed the G7 with FDA, but as of its Q3 earnings call in November 2019, they say they’re planning for a limited launch in late 2020 followed by a more broad commercial launch in 2021. Among the most exciting news, I recently had a chat with my local AMSL rep. According to Sayer, the upcoming G6 will have a variety of incremental improvements: The G6 will be incrementally more accurate than the current generation. The system consists of the Personal Diabetes Manager (PDM) and the Pod, which is worn on body and delivers non-stop insulin for three days. This will provide even quicker access for up-to-date information in the user’s corresponding Insulet Provided Glooko account. However, management noted slight weakness again this month amid worsening regional outbreaks. Abbott received FDA clearance last month for its FreeStyle Libre 2 device as an iCGM, FDA's designation meant for CGMs interoperable with other medical devices used to help manage diabetes that previously put Dexcom's G6 in a category of its own. 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