Tag Archives: CGM

Dexcom Announces New CGM Registry and Global Business Service Site in Lithuania; Dario Appoints Former LifeScan Exec to Scientific Advisory Board

Yesterday, a series of diabetes-related news items were observed: Dexcom announced its first registry committed to tracking in-hospital real-time CGM use outcomes; Dexcom announced plans to build a global business service center in Lithuania; and DarioHealth appointed Eric Milledge as chairman of its Scientific Advisory Board. Below, FENIX provides highlights and insights on the respective news items.

This content is for Read Less members only.
Already a member? Log in here

Ascensia Takes Over WW Eversense CGM Distribution; Xeris and Senseonics Q2 ’20 Earnings Update; Precigen ActoBio Announces Positive Topline Results for T1DM Modulator

Four diabetes-related news items have been observed: Ascensia announced a strategic partnership with Senseonics for world-wide commercialization and distribution of the Eversense implantable CGM; Senseonics hosted its Q2 ’20 earnings call (press release), Xeris hosted its Q2 ’20 earnings call (press release), and Precigen ActoBio announced positive topline results from its Ph1b study of AG019 for the treatment of early-onset T1DM. Below, FENIX provides highlights of the respective news items, including thoughts on the curious partnership between Ascensia and Senseonics in the context of the existing partnerships between Senseonics/Roche and Ascensia/POCTech.

This content is for Read Less members only.
Already a member? Log in here

Libre 2 Launched in the US; Libre 2 App Not Yet Available

Abbott has officially launched its Libre 2 CGM in the US, although the website (view here) has not yet been updated at the time of this publication. Of note, Abbott disclosed the Libre 2 App remains under review by FDA, suggesting the user must purchase the dedicated reader. Below, FENIX provides an excerpt from the Libre 2 launch email as well as brief thoughts on how the lack of a Libre 2 App could impact the initial launch.

This content is for Read Less members only.
Already a member? Log in here

Dexcom Partners with Current Health for Remote Patient Monitoring; Nemaura to Integrate with Activity Trackers; Roche Q2 ’20 Earnings Update

Three diabetes-related news items have been observed: Dexcom has partnered with Current Health for remote patient monitoring, Nemaura announced it will integrate activity tracker data into its proBEAT app and Roche hosted its Q2 ’20 earnings call (press release; slides). Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.
Already a member? Log in here

New Non-Invasive CGM Player Emerges (Movano); Dexcom G6 Direct-to-Apple Watch Delayed?

Last week, Movano Inc. (view website), the developer of a novel non-invasive CGM, announced it exited “stealth mode” following the receipt of $10M in additional funding. Since its founding in 2018, the company has raised a total of $27M. Below, FENIX provides insight into the new Movano CGM in the context of other non-invasive CGM technology as well as thoughts on Dexcom’s apparent delayed launch of its direct-to-Apple Watch feature and Abbott’s potential to offer a similar feature for Libre 2.

This content is for Read Less members only.
Already a member? Log in here

First Libre 3 Clinical Study Initiated

A CT.gov record has been observed for what is believed to be the first Abbott Libre 3 clinical trial. Abbott publicly disclosed the existence of Libre 3 during its Q1 ’19 earnings call (previous FENIX insight). Recall, the Libre 2 CGM was recently approved in the US, but its use with integrated systems is limited due to Vitamin C interference (previous FENIX insight). There is no mention of Vitamin C in the Libre 3 CT.gov record. Below, FENIX provides an overview of the new Libre 3 study as well as potential insight into the timing of its initiation in the context of the Libre 2 US label restrictions.

This content is for members only.
Already a member? Log in here

Nemaura Files PMA for Non-invasive CGM; Medtronic launches Mio Advance Infusion Set

Two diabetes-related news items have been observed: Nemaura Medical announced it has filed a PMA with FDA for its sugarBEAT non-invasive CGM and Medtronic launched the Mio Advance infusion set in the US. In conjunction with the Nemaura filing announcement, the company also hosted a call with investors discussing the company’s commercial efforts (US and ex-US), partnership opportunities, and development of a new continuous temperature monitor. Below, FENIX provides highlights and insights relating to the sugarBEAT PMA submission as well as brief thoughts on the new Medtronic infusion set.

This content is for Read Less members only.
Already a member? Log in here

Menarini Launches GlucoMen CGM in Europe

Menarini announced its GlucoMen Day CGM is now broadly available in Europe through Menarini’s affiliates and partners (in territories not directly covered by Menarini). Recall, in April 2019, WaveForm (formerly AgaMatrix) partnered with Menarini to market the CGM in ex-US geographies (previous FENIX insight). WaveForm received CE Mark for the CGM in November 2019 (previous FENIX insight). Below, FENIX provides thoughts on the market potential for GlucoMen in the context of its key differentiators (e.g. needle-less insertion sensor insertion).

This content is for Read Less members only.
Already a member? Log in here

Medtronic 780G Data Impresses, but CGM Remains a Weak Point; Medtronic ADA 2020 Investor Event

Medtronic hosted its annual ADA investor event (view slides) and provided a strategic update to the company’s diabetes business. Medtronic also highlighted the 780G Advanced Hybrid Closed-loop data presented at today’s ADA conference as well as a pipeline update, including the CGM sensor roadmap. Furthermore, Medtronic announced a $337M investment from Blackstone Life Sciences (view press release) to support undisclosed diabetes development programs. Below, FENIX provides highlights from the Medtronic ADA investor event and insight into the potential market implications of 780G and Medtronic’s next-gen CGM platform.

This content is for Read Less members only.
Already a member? Log in here

Senseonics Q1 ’20 Earnings Update

Yesterday, Senseonics hosted its Q1 ’20 earnings call (press release) and provided updates to its business including the company’s new strategic priorities following the suspension of its commercial activities. Importantly, Q1 ’20 net revenue fell to $36k compared to $3.4M in Q1 ’19. Below, FENIX provides highlights and insights from the call.

This content is for Read Less members only.
Already a member? Log in here