Category Archives: Glucose Monitoring

Libre 2 With Real-Time Alerts/Alarms Approved in EU

Abbott announced it received CE Mark for the FreeStyle Libre 2, which now includes optional real-time alerts/alarms. Abbott said it will price Libre 2 at parity to the original Libre System and the company is planning an EU launch in the coming weeks. Abbott did not disclose its regulatory/commercial plans for the US; however, this remains a large market opportunity for the company and is anticipated in the coming months. Importantly, during Abbott’s EASD symposium, it was shown that the Libre 2 CE Mark approval includes the updated algorithm for overall 14-day accuracy at 9.5% MARD (US is 9.4%). Below, FENIX provides the key highlights and potential implications to the CGM market.

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 H2H Tresiba vs. “Lantus” CGM Crossover Study (SWITCH PRO)

A CT.gov record for a new Ph4 T2DM basal-only crossover study (SWITCH PRO) comparing Tresiba (U100) to “Lantus” has been observed. The study was likely named SWITCH PRO because of the crossover design and the use of Abbott’s Libre Pro blinded CGM. Below, FENIX provides thoughts on how Novo could leverage the study to augment its results from the previous SWITCH 1 and SWITCH 2 studies as well as context for the use of time-in-range as the primary endpoint to be first such trial included in the Tresiba label.

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.

One Drop Now Integrates with Apple Watch

One Drop announced its blood glucose management platform now integrates directly with the Apple Watch. Previously, One Drop’s Apple Watch app required users to manually input BG data. Below, FENIX provides thoughts on the One Drop/Apple Watch integration as a source of new patients for One Drop.

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 New Non-Invasive CGM Data

Nemaura Medical announced positive results from an interim analysis of its SugarBEAT non-invasive CGM study. According to the press release, Nemaura plans to launch SugarBEAT in the UK “in the coming months” with FDA fling scheduled for Q1 ’19. Below, FENIX provides thoughts on the potential impact of a 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.

Livongo-Abbott Integration with Libre Pro

Livongo announced a partnership with Abbott to integrate the FreeStyle Libre Pro into the Livongo for Diabetes program. The integration with a professional (retrospective) CGM makes sense given Livongo’s focus on patient education and behavior-based treatment. Below, FENIX provides a unique perspective that the Abbott partnership could signal a limitation in Livongo’s diabetes solution.

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.

Senseonics Partners with Beyond Type 1 for Patient Awareness/Education

Senseonics and Beyond Type 1 announced a collaboration to make the Eversense implantable CGM the “worldwide presenting sponsor of the Type One Run.” Beyond Type 1 is a patient advocacy organization primarily focused on providing patient education and resources through social media. Below, FENIX provides perspective on the partnership opportunity for Senseonics.

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.

Medtronic Guardian Sensor 3 CGM Now Integrated with 630G

Medtronic has started notifying HCPs that its 630G sensor augmented pump (SAP) with low glucose suspend is now available with the Guardian Sensor 3 CGM. This is the same sensor that is being used with the 670G hybrid closed-loop as well as the standalone Guardian Connect CGM system. Medtronic did not issue a press release on the new 630G/Guardian Sensor 3 integration. Below, FENIX provides observations and thoughts on the upgraded sensor integration.

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 Acquires TypeZero

Dexcom announced it has acquired TypeZero. Recall, TypeZero has developed a proprietary inControl algorithm for insulin dose adjustments. The acquisition is viewed as highly positive for both sides: Dexcom gains future revenue streams and IP while TypeZero investors are able to exit with a presumably attractive return. Below, FENIX provides insight into the acquisition.

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.

Medtronic CY Q2 ’18 (FY Q1 ’19) Earnings Update

Medtronic hosted its CY Q2 ’18 (FY Q1 ’19) earnings (press release) and provided a brief update to its diabetes business unit. Below are 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.

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.

Medtronic Launches 670G & Guardian Connect Gamification App

Medtronic announced the launch of its “Inner Circle” patient engagement program for patients on either the 670G hybrid closed-loop or the standalone Guardian Connect CGM. Recall, Medtronic initially disclosed its plans for Inner Circle during the June 2018 Investor Day.

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.