Category Archives: Glucose Monitoring

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. 

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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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.

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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Livongo Acquires Behavioral Health Company

Livongo announced its intention to acquire myStrength, a Colorado-based behavioral health company focused on chronic conditions including depression, anxiety, stress, substance use disorder, chronic pain, opioid addiction and recovery, and insomnia. Below, FENIX provides insight into the acquisition including thoughts on how Livongo may be leveraging myStrength to expand Livongo’s core diabetes business.

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

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

Libre Reaches 1.3M Users; Abbott Q4 ’18 Earnings Update

Abbott hosted its Q4 ’18 earnings call and provided brief updates on its diabetes business. Of note, Abbott disclosed that Libre now has >1.3M global users, +300k from the previous quarter. Below, FENIX provides a summary from the call as well as thoughts on Libre’s growth potential.

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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JPM 2019 Day 1: DXCM, MDT, JNJ, MRK; New Bigfoot Deal with Lilly

The first day of the 2019 J.P. Morgan Healthcare conference kicked off with diabetes-related presentations from Dexcom, Medtronic, J&J, and Merck. Additionally, Bigfoot announced a non-exclusive license with Lilly for inclusion of Lilly RAI in Bigfoot’s connected care ecosystem and Ascensia entered into an agreement with POCTech for CGM distribution in 13 undisclosed geographies. Also of note, FENIX provides a brief discussion on an early stage CGM company called Glutalor which has David Simmons, former Vice President and Chief Medical Officer at Ascensia Diabetes Care, on the scientific board. Below, find a topline summary of key takeaways by company followed by more in-depth……

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.

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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Purchase Blast$599.00

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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.

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.

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.

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

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.

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.

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

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