Category Archives: Glucose Monitoring

New Glooko Business Model; Glooko Mobile App to be Given Away for Free

Glooko announced it is removing the subscription fee for its data management platform. Previously, users who did not have coverage through their insurance or employers were required to pay a fee to access the platform. Additionally, the Glooko/Senseonics data integration appears to be complete. Now, users can directly sync Eversense data to the Glooko platform via the Senseonics Cloud. Below, FENIX provides thoughts on Glooko’s new business model as well as insight into how the integration with Eversense likely benefits Senseonics more than Glooko.

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Dexcom Expands Customer Support; Q4 ’18 Earnings Update

Dexcom hosted its Q4 ’18 earnings call and provided updates to its diabetes business including an announcement that the company is expanding its customer and technical support capabilities through ex-US resources. As such, Dexcom is downsizing an undisclosed portion of its US workforce. Below, FENIX provides highlights and insights from the earnings call.

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Biocorp/DreaMed Partnership; Abbott Libre and Valeritas V-Go RWE

Three diabetes device-related press releases were observed today including a new Biocorp/DreaMed partnership, as well as Abbott Libre and Valeritas V-Go patch pump RWE, presented at ATTD 2019. Below, FENIX provides an overview of the news as well as thoughts on how the Biocorp/DreaMed partnership appears to favor DreaMed.

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Connected Pens: New Novo and Abbott Partnership for Data Integration

Today, Abbott and Novo Nordisk announced a non-exclusive partnership to integrate insulin dosing data from Novo’s connected insulin pens into Abbott’s digital health tools compatible with the FreeStyle Libre system. Below, FENIX provides insights into the Novo/Abbott partnership.

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Connected Pens: Novo Expanded Capability with Glooko; Biocorp/AgaMatrix Partnership

Prior to the start of the 2019 ATTD conference, two diabetes technology-related press releases have been observed. First, Glooko announced that its cloud-storage platform will integrate with Novo Nordisk’s connected pens and Dexcom’s G6 CGM. Second, Biocorp and AgaMatrix entered into a partnership for the distribution of Biocorp’s wraparound connected pen device now called “Mallya” (formerly Easylog). Below, FENIX provides insight into the respective news including thoughts on why the remote upload feature is critical for Novo.

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Medtronic Receives Breakthrough Device Designation; CY Q4 ’18 (FY Q3 ’19) Earnings Update

Medtronic hosted its CY Q4 ’18 (FY Q3 ’19) earnings call and provided brief updates to its diabetes device pipeline and commercial activities. Of note, Medtronic also announced that FDA granted Breakthrough Device Designation for its Personalized Closed Loop (PCL) insulin pump system (Breakthrough Devices Program Guidance was finalized in December 2018). Below, FENIX provides highlights from the earnings call as well as perspective why Medtronic chose to pursue Breakthrough Device Designation.

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Thoughts on iPump Special Controls

Yesterday, FDA approved the first interoperable pump through the de novo pathway and created a new pump category called “alternate controller enabled” (ACE) infusion pump. With the approval of the new class, FDA established “special controls” that must be met in order to qualify as an ACE pump, similar to Dexcom’s G6 iCGM approval in March 2018. Below, FENIX provides analysis and summary of these controls as well as thoughts on how achievable the ACE special controls are compared to the iCGM special controls.

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Senseonics/Roche Renew Distribution Agreement; Acquisition Unlikely

Senseonics announced it has come to an agreement with Roche to extend the existing distribution agreement for the Eversense implantable CGM. Additionally, Senseonics held an investor webcast to discuss the updated agreement. Below, FENIX provides a summary of the webcast as well as thoughts on why it may have made more sense for Roche to extend the partnership than to outright buy Senseonics.

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New Roche Smartphone BGM; Q4 ’18 Earnings Update

Roche hosted its Q4 ’18 earnings call and briefly discussed its diabetes device portfolio. For the first time, Roche disclosed it is developing a smartphone-based BGM called Accu-Chek SugarView 2.0 with an anticipated European launch in 2019. It is unclear if SugarView 1.0 was ever launched. According to Roche’s investor presentation, Accu-Chek SugarView 2.0 is “for non-insulin dependent T2 PwDs, allowing for meter-free blood glucose monitoring using Accu-Chek Active test strips and a smartphone camera.” Below, FENIX provides thoughts on the Accu-Chek SugarView 2.0, including product details, and other diabetes-related highlights from the call. 

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Senseonics Receives MRI Approval for Eversense Implantable CGM

Senseonics announced that its Eversense implantable CGM has been approved for MRI-compatibility (i.e. patients can receive an MRI without the sensor having to be extracted). Of note, patients must still remove the external transmitter prior to the MRI procedure. Below, FENIX provides thoughts on how this label update could impact Eversense uptake.

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