Category Archives: Glucose Monitoring

SENS: Eversense XL US Pivotal Trial and Insulin Dosing Claim sPMA

Earlier this week, Senseonics announced that the first US study participant has been implanted with the 180-day Eversense XL sensor for the pivotal PROMISE study. Additionally, Senseonics also announced they have submitted PMA supplements for an insulin dosing claim and for the removal of an MRI contraindication for the Eversense 90-day CGM system. Below, FENIX provides additional thoughts on each of these topics. Eversense XL PROMISE study details The aim of this study is to evaluate the efficacy and safety of the Eversense XL CGM in 180 diabetes patients over a 180-day period. Of note, a brief CT.gov search for Senseonics’ PROMISE study did not show any records. Recall, Eversense XL 180-day sensor is commercially available in Europe……

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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New Medtronic IQcast Feature And Adocia RAI iLet Trial

Yesterday, Medtronic announced a hypoglycemia prediction feature called “IQcast” for the Sugar.IQ personal diabetes assistant app while Adocia announced the initiation of an AID trial evaluating BioChaperone Lispro and other RAI using the Beta Bionics’ iLet closed-loop system. Below, FENIX provides additional thoughts on each of the topics. Medtronic launches ‘IQcast’ hypo prediction feature for Sugar.IQ users According to the press release, IQcast can predict the likelihood of a hypoglycemia event anywhere between 1-4 hours in advance. This news is in-line with previous guidance from Medtronic indicating its intentions to extend the predictive alert time of Guardian Connect up to 4 hours. Of note, Medtronic denoted……

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Thoughts on 2019 ADA Standards of Care

The ADA announced the publication of their 2019 Standards of Medical Care in Diabetes Care. Of note, the ADA has aligned their CVD recommendations with the ACC’s recent T2DM ASCVD recommendations. The ADA also added a new dedicated section titled “Diabetes Technology,” which includes information previously incorporated in the “Glycemic Targets” section. The ADA also provides a cost breakdown of pharmacologic treatment options. Below, FENIX has provided highlights and insights from the updated ADA 2019 Standards of Care.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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Lilly 2019 Guidance Summary

Today, Lilly hosted its 2019 Guidance and Investment Community Meeting and discussed potential key milestones for 2019. Importantly, Lilly announced late stage development plans in obesity and NASH and provided more information on the Ph3 dose titration for its QW injectable GIP/GLP-1 dual agonist tirzepatide. Connected care was also featured, and several comments were made on guidelines updates and new PBM coverage positively affecting Trulicity and Jardiance in 2019. Below, FENIX provides a summary and thoughts on diabetes-related highlights from the event. 

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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Abbott TV DTC for Libre 14-day system

FENIX observed that Abbott is conducting a TV DTC campaign for the Freestyle Libre 14-day system, placing a strong emphasis on the ease of sensor scanning without fingersticks. Below, FENIX summarizes the key messages and imagery from the new Libre commercial and compares it to Dexcom’s TV DTC campaign from earlier in 2018 (previous FENIX insight). Currently on iSpot.tv, there are two 30-second commercials listed for FreeStyle Libre: ‘No Fingersticks: Libre 14-day system’ (30 sec) – Newly observed from November 2018 ‘No more Fingersticks’ (30 sec) – First aired on February 2018 While Abbott has a central theme on the ease of sensor scanning without fingersticks for……

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

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Lilly’s Evidation Health Collaboration Expanded To Discover Novel Digital Health Measures

Today, Lilly and Evidation Health announced the expansion of their collaboration with a multi-year agreement that will provide Lilly with global access to Evidation’s Andromeda data platform. Of note, Evidation Health also has prior partnerships with Tidepool and Sanofi. Below, FENIX provides additional thoughts on this collaboration in the context of Lilly’s connected care strategy in diabetes. According to the press release, Lilly will leverage the Andromeda data platform across different therapeutic portfolios, including diabetes, to support the clinical utility of digital medicine and improve personalized health outcomes. The press release also noted that Andromeda data platform is being used……

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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Tidepool Loop funded at $6M

Today, JDRF and Helmsley Charitable Trust announced a collaborative grant agreement by providing $6M of funding to Tidepool for the development of “Tidepool Loop”. Recall, Loop is an open-source, unregulated automated insulin delivery (AID) app for iPhone that connects to an insulin pump and CGM using BLE (see image below). Of note, Tidepool intends on further developing the app by making it an FDA-regulated, hybrid closed-loop AID app for iOS with interoperability across multiple insulin pumps and CGMs. Below, FENIX provides additional thoughts on Tidepool Loop. Source: Tidepool website This news comes as no surprise considering the recent announcement from Tidepool in October 2018, indicating the initiation of the Loop project, which aimed to develop……

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

New Sanofi and Dexcom trials: Efpeglenatide add-on to MET+/-SU and G6 vs. Libre FGM

Recently, FENIX has observed new Sanofi and Dexcom trials on CT.gov. Sanofi has posted its Ph3 efpeglenatide trial (AMPLTITUDE-S) as an add-on to metformin (MET) with or without sulfonylurea (SU). Additionally, Dexcom has an investigator-initiated trial comparing the G6 CGM with Libre FGM in T1DM (ALERT-T1). Below, FENIX provides thoughts on the respective studies, as well as a comparison of GLP-1RA trials with MET+/-SU. Sanofi Efpeglenatide Ph3 study as an add-on to MET±SU (AMPLTITUDE-S) Sanofi has initiated AMPLITUDE-S for its QW GLP-1RA, efpeglenatide, as an add-on to MET±SU. Of note, this is the last pivotal study for efpeglenatide regulatory submission, anticipated to……

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

CGM: Novel Non-invasive Platform Similar To Libre CGM Data

Today, Know Labs, a diagnostic solutions company evaluating the use of its Bio-RFID platform with non-invasive UBANDTM wearable (Fitbit like device) announced laboratory comparison test results of UBAND vs. Abbott FreeStyle Libre. Of note, the results demonstrated ~90% correlation to the Libre CGM data. The company previously announced the laboratory comparison test results of UBAND vs. Dexcom G5. Below, FENIX provides thoughts on non-invasive option for CGM.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Dexcom Analyst Day Overview

Dexcom hosted its first ever Analyst Day and provided updates across its business including the company’s strategy to expand its market opportunity to non-intensive T2DM, gestational diabetes, and CGM use in hospitals. Of note, Dexcom displayed a picture of the fully disposable second generation Verily CGM which is being positioned as the product that will allow Dexcom to enter the non-intensively managed T2DM market. Below, FENIX provides an overview of the Analyst Day as well as thoughts on Dexcom’s pipeline activities and commercial opportunity. Pipeline Roadmap Dexcom senior management provided an overview of its pipeline activities including device integrations, predictive……

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.