Category Archives: Glucose Monitoring

Bigfoot Unity and Zegalogue RTU Dasiglucagon Now Available in the US; Carmot Initiates GIP/GLP Trial in Obesity and T2DM; Dexcom Launches TIR Educational Campaign; Dario Selected as Digital Health Provider for Coastal Family Health Center

Ahead of the 2021 ADA conference (June 25-29), a series of cardiometabolic-related news items have been observed: Bigfoot announced the Bigfoot Unity connected system is now available in select markets across the US; Zealand announced US commercial availability of its dasiglucagon hypoglycemia product, Zegalogue; Carmot Therapeutics announced initiation of a Ph1 trial evaluating a QW dual GLP-1/GIP RA, CT-388; Dexcom announced the launch of an awareness and educational campaign called The Global Movement for Time in Range; and Dario Health announced it was selected as a digital health provider for Coastal Family Health Center. Below, FENIX provides highlights and insights for the respective news items.

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Bigfoot Unity Video Highlights Connected System; Celon’s Next-gen GPR40 Enters Ph2 Development

Two diabetes-related items have been observed: Bigfoot recently highlighted its Bigfoot Unity system ahead of the impending launch; and Celon Pharma announced it filed for approval to begin a Ph2 trial investigating a second-generation oral QD GPR40 agonist, referred to as CPL’280, for the treatment of T2DM. Below, FENIX provides highlights from the respective items as well as thoughts on Celon’s decision to advance its GPR40 agonist despite the previous failed efforts from competitors (e.g. Lilly, Amgen, etc.).

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One Drop hires former Sanofi Head of Innovation and Diabetes portfolio

One Drop announced the hiring of Sanofi’s former Head of Innovation and Diabetes Portfolio, Carrie Siragusa, as One Drop’s new VP of commercial strategy (view LinkedIn; pictured below). According to the press release, Siragusa will be part of the team tasked with commercializing a “multi-analyte dermal sensor with continuous health sensing capabilities.” Below, FENIX provides thoughts on Siragusa’s hiring in the context of One Drop’s goal to move beyond BGM as well as insight into the potential impact on the overall CGM market.

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Lilly Debuts Connected Pen at ATTD; ATTD 2021 Key News (June 3)

On Day 2 of ATTD 2021, a series of diabetes-related press releases and presentations have been observed from Lilly, Dexcom, Senseonics, and Provention Bio. Importantly, Lilly hosted a Symposium at ATTD dedicated to its new connected pen platform in which the company (for what is believed to be the first time) displayed the Tempo Smart Button device. Below, FENIX provides highlights and insights from the respective news items.

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Medtronic CY Q1 ’21 Earnings Update; FDA Accepts IND for Lilly/Dicerna Cardiometabolic Asset; Dario Digital Therapeutics Publication

Three cardiometabolic news items have been observed: Medtronic hosted its CY Q1 ’21 (FY Q4 ’21) earnings call; Dicerna announced FDA accepted Lilly’s IND application for a novel cardiometabolic asset, LY3819469, targeting the LPA gene; and Dario announced the publication of “Digital Therapeutics for Type 2 Diabetes: Incorporating Coaching Support and Validating Digital Monitoring” in Diabetes Science and Technology. Below, FENIX provides highlights and insights for the respective news items.

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InPen and Guardian 4 Sensor Receive CE Mark; Oramed Ph3 Oral Insulin Update; Adocia Files Patents for Obesity, NASH, and T2DM

Three cardiometabolic-related news items have recently been observed: Medtronic announced it received CE Mark for expanded functionality of its InPen smart insulin pen and its Guardian 4 CGM (aka Zeus); Oramed issued a letter to shareholders in which it highlighted its Ph3 oral insulin program (press release); and Adocia announced it has filed three patent families, which include obesity, NASH, and T2DM. Below, FENIX provides highlights and insights for the respective news items.

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Roche Launches Smartphone-controlled Pump; Metronom Enters CGM JV in China; FDA Draft Guidance on T2DM Glycemic Control Devices; Dario Q1 ’21 Earnings Update; New Ascensia BGM Portal; Metacrine Ph2 NASH Trial

A series of cardiometabolic news items have been observed: Roche announced the launch of its mySugr Pump Control smartphone app; Dinova Medtech and Metronom Health have created a joint venture in China for CGM development and commercialization; FDA issued a draft guidance on medical devices intended to improve glycemic control in T2DM; Dario hosted its Q1 ’21 earnings call; Ascensia announced the launch of the new “GlucoContro.online” patient and provider portal for diabetes management and analytics; and Metacrine has enrolled the first 60 patients in its MET642 Ph2a NASH trial. Below, FENIX provides highlights and insights from the respective news items.

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Lilly Connected Pen Update; Novo Q1 ’21 Post-earnings Event; Provention Bio, BD, ICPT, and REGN Earnings Updates

A series of cardiometabolic-related news items have been observed: Lilly provided an update on its connected pen development, including the disclosure of the Tempo Smart Button (view press release); Novo Nordisk hosted its post-Q1 ’20 earnings event (see previous FENIX insight on Q1 ’21 Novo earnings from May 5); Provention Bio (press release), Becton Dickinson (press release), Intercept (press release; slides) and Regeneron (press release) hosted their respective CY Q1 ’21 earnings calls. Below, FENIX provides highlights and insights from the respective news items, including thoughts on BD’s decision to spin off its diabetes business.

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