Category Archives: Glucose Monitoring

New Nemaura H2H CGM Study; Welldoc partners with Redox to integrate BlueStar with EHRs

A series of diabetes-related news has been observed including an announcement that Nemaura plans to initiate a H2H study comparing its sugarBEAT CGM with a “highly successful major incumbent CGM sensor” (press release) as well as Welldoc’s new strategic partnership with Redox Inc., to integrate BlueStar with EHRs (press release). Below, FENIX provides additional highlights and insights on Nemaura’s H2H study, especially in the context of the comparative CGM used in the study.

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FDA Issues Final Rule on Definition of “biological product”; ATTD 2020 Key Press Releases (Feb 20)

On the second day of the ATTD 2020 conference, a series of diabetes-related press releases have been observed including Abbott Libre RWE, Tandem to file Control IQ for peds in March 2020, Roche’s new “InsulinStart” program, Companion Medical compatibility with Fiasp, and MannKind Afrezza PK and pulmonary function data. Separate from the conference, FDA announced that it has issued a final rule on the definition of a biological product ahead of the March 23, 2020 insulin reclassification from a drug to a biologic. Below, FENIX provides highlights and insights from the respective news items.

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Insulet Partners with Dexcom and Abbott; ATTD 2020 Key Press Releases (Feb 19)

With the start of the ATTD 2020 conference, a series of diabetes technology-related press releases have been observed including partnerships between Insulet/Dexcom, Insulet/Abbott, Dexcom/Dreamed, and Biocorp/iSage Rx. Additionally, Dario Health presented new data at ATTD 2020 for its connected BGM platform, and Diabeloop initiated a trial to support 510(k) clearance of its automated insulin delivery algorithm. Below, FENIX provides highlights and insights from the respective news items.

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Medtronic CY Q4 ’19 (FY Q3 ’20); Cigna Reimburses Eversense Implantable CGM; Diasome HDV-Lispro Ph2 Topline Data

Yesterday, a series of diabetes-related news were observed including Medtronic’s CY Q4 ’19 (FY Q3 ’20) earnings call, Senseonics’s positive coverage decision from Cigna for the Eversense implantable CGM, and Diasome’s topline data from its Ph2 OPTI-1 study. Below, FENIX provides highlights and insights from the respective news items.

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Dexcom Q4 ’19 Earnings Update

Dexcom hosted its Q4 ’19 and FY ’19 earnings call and provided updates to its CGM business. Of note, Dexcom has continued to show significant revenue growth, reaching total topline sales of nearly $1.5B in 2019 (+43% YOY). Below, FENIX provides highlights and insights from the earnings call including a Dexcom comment on Lilly’s smartpen launch.

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Senseonics Integrates with Companion Medical; Nemaura Medical CY Q4 ’19 Earnings Update

Senseonics announced a new partnership with Companion Medical to integrate Eversense implantable CGM data into the Companion Medical InPen platform. Additionally, Nemaura Medical issued a press release for its FY Q3 ’19 (CY Q4 ’19) earnings. Below, FENIX provides thoughts on the partnership including why it makes sense for both Senseonics and Companion Medical.

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Dexcom Non-intensive G6 CGM Updated Approval; Dexcom G5 Receiver Recall; FDA Concludes MET NDMA Impurity Investigation

A series of diabetes-related news has been observed including a new 510(k) clearance for Dexcom’s G6 iCGM in non-intensive diabetes management, Dexcom G5 Mobile Class 2 Device recall, and FDA finalized its investigation into potential metformin impurities. Below, FENIX provides highlights and insights for the respective news items.

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Thoughts on New CVS Program to Eliminate Diabetes Drug OOP Costs

CVS Health recently announced a new program called “RxZERO,” which is said to completely eliminate all out of pocket costs (OOP) for diabetes prescription drugs. According to the press release, RxZERO will provide the benefit to members “without raising costs for the plan sponsor or increasing premiums or deductibles for all plan members.” Below, FENIX provides thoughts on the RxZERO program in the context of the ongoing drug pricing debate in the US.

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i-SENS Receives FDA Clearance for Another BT BGM

Approximately 1 week after i-SENS received 510(k) clearance for the Caresens S Fit BT BGM, FDA has cleared another i-SENS Bluetooth BGM called “Caresens S Clear BT.” Below, FENIX provides brief thoughts on the new i-SENS BGM.

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New G&L Bs-Glargine Ph1 Trial to Support Approval; J&J and Abbott Q4 ’19 Earnings Updates; New Medtronic AHCL Study; Biocon Generic Dapa Tentatively Approved by FDA

A series of diabetes-related news items have been observed including Gan & Lee completed a Ph1 biosimilarity study for its glargine, earnings calls from Johnson & Johnson and Abbott, Medtronic initiated a new advanced hybrid closed-loop study, and Biocon received tentative approval for generic dapagliflozin. Below, FENIX provides diabetes-related highlights and insights from the calls including thoughts on how the G&L study appears to be in-line with FDA’s thinking on biosimilar insulins.

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