Category Archives: Insulin Delivery

Thoughts on ADA 2020 Standards of Care

ADA recently updated its Standards of Medical Care in Diabetes for 2020, which includes key additions across multiple drug classes. Of note, the standards now include a recommendation for initiating SGLT2i or GLP-1RA therapy in patients with ASCVD, HF, or CKD (SGLT2i only) who are already at their A1C goal. Interestingly, while the guidelines were updated to include discussion of the CANVAS/R, CREDENCE, DECLARE, REWIND, and CARMELINA trials, CAROLINA and DAPA-HF trials were not addressed. Below, FENIX provides thoughts and market implications for selected guideline updates.

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Medtronic Acquires Klue; New Tandem SGLT2i+Closed-loop Trial

Medtronic announced it has completed the acquisition of “Klue,” a company developing behavior tracking technology to “provide real-time insights into when a person is consuming food.” Additionally, a new CT.gov record has been observed for an investigator-initiated trial evaluating Tandem’s closed-loop systems (Basal IQ and Control IQ) in T1DM patients on an SGLT2i. Below, FENIX provides thoughts on the news items including how Klue may help to enhance Medtronic’s PCL while still leaving some potential hurdles.

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Tirzepatide CVOT vs. Trulicity; Lilly 2020 Guidance Summary

Today, Lilly hosted its 2020 Guidance and Investment Community Meeting and discussed potential key milestones for 2020. Importantly, Lilly disclosed that its tirzepatide CVOT will be conducted H2H vs. Trulicity. Below, FENIX provides highlights and insights from the call including thoughts on why a tirzepatide CVOT vs. Trulicity makes sense.

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Lilly/Dexcom Updated Partnership for CGM

Lilly announced it has entered into a new agreement with Dexcom to integrate Dexcom CGMs into Lilly’s personalized diabetes management system. Recall, Lilly and Dexcom first entered into their connected care partnership back in 2017, following Lilly’s announcement on its connected ecosystem. Below, FENIX provides potential insights into the updated Lilly/Dexcom partnership.

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Tandem Control IQ Approved as first “iAlgorithm” Device

Tandem announced it received FDA clearance for Control IQ as the first “interoperable automated glycemic controller device” (denoted as iAGC below and previously described as “iAlgorithm” by FENIX). Notably, FDA also issued a press release regarding the approval. With Control IQ’s approval, FDA has established new special controls for the final component of interoperable systems. Dexcom’s G6 CGM was the first interoperable CGM (iCGM), and Tandem’s t:slim X2 was the first alternate controller enabled pump (ACE pump). Below, FENIX provides insights on the Control IQ approval in the context of future interoperable systems in development as well as thoughts on how JDRF’s new plea to UHC could help Tandem expand access.

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Teplizumab Regulatory Update; Sanofi Partners with Biocorp; Livongo Preferred on ESI; Omnipod Horizon Pivotal Trial Initiated; Glooko Partners with Mellitus Health

A series of diabetes-related new items were observed today including an update on Provention Bio’s teplizumab, a new Sanofi/Biocorp connected pen partnership, Livongo’s preferred status on ESI, Insulet’s Omnipod Horizon pivotal study, and more. Below FENIX provides insights and context from each respective news item.

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Xeris Positive Ph2 Data in PBH; Oramed Partnership with Tianhui; Glooko Privacy Shield Certification

Three news items have been observed today across diabetes players including Xeris, Oramed, and Glooko. Xeris announced positive data from their Ph2 trial in post-bariatric hypoglycemia, Oramed has partnered with Tianhui Incubator of Technologies to launch ORMD-0801 in China in 2 years, and Glooko announced Privacy Shield certification from the US Department of Commerce. Below, FENIX provides context and insights on these news items. Xeris Reports Positive Ph2 Data in Post-Bariatric Hypoglycemia Xeris announced positive results from the in-clinic stage of the Ph2 study evaluating their ready-to-use (RTU) glucagon in patients at risk of postprandial hypoglycemia following bariatric surgery. Participants in the trial were……

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Sanofi To Move Away From Diabetes/CV; Sanofi 2019 Capital Markets Day

Sanofi hosted its 2019 Capital Markets Day and outlined its new strategy including the R&D focus, which does not include diabetes or cardiovascular projects. In a separate press release, Sanofi also announced it is restructuring the deal with Regeneron for Praluent and Kevzara. Below, FENIX provides CV/Met related highlights from the CMD presentation as well as thoughts on the new direction for Sanofi’s business.

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Beta Bionics’s iLet Breakthrough Designation; Roche Receives CE Mark for Novel BG Test; Glooko Receives ISO 13485 Certification

FENIX has observed several announcements across diabetes technology players. First, Beta Bionics has received breakthrough device designation for the iLet Bionic Pancreas System from the FDA. Note, Beta Bionics is the only manufacturer to receive this designation for 3 system configurations (insulin-only as well as dual-hormone and glucagon-only using Zealand’s dasiglucagon), as no other companies have disclosed configurations beyond insulin-only. Additionally, Roche announced it has received CE Mark for the Accu-Chek SugarView, a meter-free BG monitoring system. Further, Glooko has received ISO 13485 certification, meeting requirements for safety and quality of their system. Below, FENIX provides context and insights on these announcements.

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Novo 2019 Capital Markets Day Highlights and Analysis

Novo hosted its 2019 Capital Markets Day and provided updates on the strategic direction of the company through 2025 including commercial activities and R&D strategy. Of note, Novo provided clarity on Rybelsus positioning vs. Ozempic and competitor products as well as details on novel drug delivery technologies, including two oral peptide delivery methods being developed at MIT and the semaglutide+AM833 injection device. Below, FENIX provides details and insights from the call.

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