Category Archives: Glucose Monitoring

Abbott/Tandem Finalize AID Partnership; What is Tandem’s Role?

Abbott and Tandem Diabetes Care announced the finalization of an agreement for the two companies to develop and commercialize “integrated diabetes solutions.” Recall, the companies first announced their intention to work together in October 2019 (previous FENIX insight). Below, FENIX provides thoughts on the partnership, including potential insight into how Abbott may be leveraging the Tandem partnership to deal with the Libre 2 Vitamin C interference issue.

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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).

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Libre 2 AID Compatibility Issue Worse Than Expected

The Libre 2 FDA approval documents have been released, and the answer is now known as to why Libre 2 was not approved to be compatible with automated insulin delivery (AID) systems. Below, FENIX provides thoughts and insight into the issue and Abbott’s potential next steps.

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Libre 2 AID Compatibility Hypothesis

Earlier this week, Abbott announced FDA approval of Libre 2, its successor to the highly successful Libre 14 day CGM system (previous FENIX insight). Despite all of the indicated improvements that Libre 2 received, it was clearly worded that Libre 2 is not approved for use with automated insulin delivery (AID) systems. Below, FENIX hypothesizes as to the reason.

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Abbott Libre 2 Promotion Takes Shots at Dexcom G6; Libre 2 Digital DTC Initiated

Following the Libre 2 FDA approval (see previous FENIX insight), Abbott authored a blog post on its website (view here), which includes a patient DTC video (view on Youtube) as well as static images that directly counter-message Dexcom’s G6 CGM. Additionally, the Libre 2 website is now live with a “coming soon” message and webform to be notified when Libre 2 becomes available. Below, FENIX provides an analysis of Abbott’s early Libre 2 messaging/counter-messaging and potential insight into a Dexcom response.

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VERTIS-CV Questions Remain; Dexcom Partnered for COVID-19 Remote Monitoring; New Libre RWE; Nemaura Continues PR Blitz; ADA Key Press Releases (June 16)

On the final day of ADA 2020, four diabetes-related news items were observed: full results from the ertugliflozin VERTIS-CV study, Dexcom partnered with KORE for COVID-19 remote monitoring, additional Libre RWE, Nemaura continues on its ADA PR blitz. Below, FENIX provides context and analysis for the announcements.

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Dapa Reduces Progression to T2DM; Teplizumab Continues to Delay T1DM Onset; Arecor AT247 Faster than Fiasp; ADA Key Press Releases (June 15)

Today, twelve diabetes-related news items were observed: DAPA-HF delays T2DM onset, teplizumab follow-up results, Arecor uRAI Ph1 data, new Afrezza practical data, Diasome HDV Ph2 results, Hua Medicine Ph3 GKA data, ORMD-0801 in NASH, Glytec CGM POC data, Biolinq’s first-in-human CGM data, and more. Below, FENIX provides context and analysis for the announcements.

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Libre 2 US Approval Was Worth the Wait for Abbott, but Not Its Pump Partners

Abbott announced FDA approval of the Libre 2 iCGM in patients 4 years of age and older; however, the initial approval comes without closed-loop compatibility. According to FDA’s 510(k) database, Libre 2 was approved on Friday, June 12, but FDA typically doesn’t update the database until Monday. Recall, Libre 2 approval had been delayed for undisclosed reasons, but FENIX recently anticipated a near-term US approval with the closure of Bigfoot’s Series C (previous FENIX insight). Below, FENIX provides thoughts on the Libre 2 approval, a comparative analysis with the Dexcom G6, and potential implications to other CGM manufacturers including Medtronic, Senseonics, Lifescan, Waveform, and Nemaura.

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Trulicity, Ozempic, Afrezza, Libre, Control IQ, and Onduo RWE at ADA 2020; Sota T2DM CKD Data; vTv Presents TTP399 Ph2 Results; ADA 2020 Key Press Releases (June 13)

Today, nine diabetes-related news items were observed: Trulicity, Ozempic, Afrezza, Libre, Control IQ, and Onduo RWE data were presented at ADA 2020 as well as new data from Lexicon (sota T2DM Ph3 CKD), vTv (Ph2 Simplici-T1), and Zealand (V-Go patch pump). Below, FENIX provides context and analysis for the announcements.

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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.

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