Jun 20,2024

mylife Loop reaches important milestone toward US approval

CamAPS FX algorithm, developed by CamDiab and partnered with Ypsomed, has received market authorization from the FDA in the United States. This milestone marks a significant step towards introducing the mylife Loop, an automated insulin delivery (AID) solution, to the US market. The mylife YpsoPump, which is part of the mylife Loop system, is currently under FDA review as an interoperable insulin pump. Sébastien Delarive, Chief Business Officer of Ypsomed Diabetes Care, highlights the importance of this approval for people with type 1 diabetes in the US, noting that mylife Loop has already demonstrated high customer satisfaction and penetration in Europe. Overall, mylife Loop combines the CamAPS FX algorithm with the mylife YpsoPump and options for continuous glucose monitoring systems from Abbott or Dexcom, providing an advanced hybrid closed-loop system for managing type 1 diabetes.

REGULATORY FDA

#closed loop

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Jun 25,2024

Welldoc Announces Collaboration to Support Cardiometabolic Health by Integrating AI-Driven Digital Coaching with Instacart’s Innovative Technology Platform to Increase Access to Nutritious Groceries

Welldoc has partnered with Instacart to improve healthcare delivery by integrating digital coaching with Instacart's grocery technology. This collaboration aims to enhance access to nutritious food and improve health outcomes for those managing cardiometabolic conditions. The partnership addresses the needs of over 100 million Americans suffering from such conditions, which are often linked to poor diet. Through this initiative, Welldoc users can seamlessly import grocery lists to Instacart, shop for recommended nutritious foods, and use programs like Instacart Health Fresh Funds.

COLLABORATION PARTNERSHIP

#product & service

#coaching

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Jun 22,2024

The American Diabetes Association Names Winners of Diabetes Innovation Challenge

The American Diabetes Association (ADA) announced the winners of its Innovation Challenge at the 84th Scientific Sessions in Orlando, Florida. The competition aimed to promote transformative solutions for diabetes care. Three winners were selected from five finalists who pitched their innovative ideas: Diatech Diabetes presented a software platform designed to enhance detection of infusion failures in insulin pump and automated insulin delivery systems ; Spotlight Communications: presented a clinical tool addressing patient-identified concerns, effectively mapping resources to meet unmet physical, mental, and social wellbeing needs; and Symbio Cell Tech introduced a biotherapy for type 1 diabetes patients that eliminates the need for encapsulation devices or anti-rejection drugs. Spect and Valendo Health were the two other finalists in the competition. The application period for next year's Innovation Challenge will open in January 2025, aiming to continue fostering innovation in the field.

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Jun 22,2024

Tandem Mobi Improves Quality of Life for People Living With Type 1 Diabetes in New Data Shared at American Diabetes Association Scientific Sessions

Tandem Diabetes Care presented findings from a survey on Tandem Mobi user satisfaction and wearability at the 84th Scientific Sessions of the American Diabetes Association in Orlando. The survey revealed that 86% of participants, regardless of their previous therapy, were satisfied or very satisfied with Tandem Mobi, underscoring its positive impact on users' quality of life. Tandem Mobi, the smallest durable automated insulin delivery system globally, launched commercially in the US in February 2024. A majority of users (77% of MDI and 80% of prior pump users) felt Tandem Mobi provided more freedom in their daily lives. Additionally, insights from an independent study highlighted improved time in range for users without increased time spent below range. The product's features, such as its small size, portability, discreteness, and compatibility with iPhones, were particularly valued among younger users with type 1 diabetes.

PRODUCT

#closed loop

#insulin pump

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Jun 18,2024

Tandem Diabetes Care to Present New Early User Insights on the Tandem Mobi System at the ADA’s 84th Scientific Sessions

Tandem Diabetes Care announced its participation in the ADA's 84th Scientific Sessions in Orlando, Florida, from June 21-24, 2024. They will host a Product Theater showcasing Tandem Mobi, the smallest durable Automated Insulin Delivery (AID) system, highlighting early user insights and its Control-IQ algorithm. Poster presentations throughout the event will cover various topics including the t:slim X2 with Control-IQ technology, user satisfaction with the t:connect Mobile Application, and wearability insights from Tandem Mobi. Tandem will also exhibit at Booth #1621, featuring demonstrations of Tandem Mobi with Dexcom G7 integration and showcasing compatibility with multiple CGM systems.

CONFERENCES
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Jun 20,2024

Tandem Diabetes Care Appoints Jean-Claude Kyrillos as Chief Operating Officer

Tandem Diabetes Care announced the appointment of Jean-Claude “JC” Kyrillos as Executive Vice President and Chief Operating Officer, effective June 21, 2024. Mr. Kyrillos comes to Tandem with more than 20 years of global executive leadership experience in medical device, digital health, and healthcare management.

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Jun 17,2024

Talisman needle-free CGM demonstrates strong correlation to blood glucose in clinical studies and moves towards large volume manufacturing

GlucoModicum has provided an update on its Talisman needle-free continuous glucose monitor (CGM), highlighting strong results from clinical studies demonstrating its correlation with blood glucose levels. The device, utilizing magnetohydrodynamic (MHD) technology, extracts interstitial fluid without needles for painless and accurate glucose monitoring. It is nearing large-volume manufacturing readiness with designs for automated production lines capable of manufacturing millions of sensors annually. GlucoModicum has secured substantial funding and is progressing towards CE marking and FDA submission, aiming for commercial launch.

CLINICAL STUDY

#cgm

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Jun 17,2024

T1D Exchange Announces 21 Real-World Data Presentations at the American Diabetes Association (ADA) 84th Scientific Sessions

T1D Exchange announced its participation in the ADA's 84th Scientific Sessions with 21 presentations showcasing real-world data on diabetes care. The presentations include findings from their Quality Improvement Collaborative and patient Registry, covering topics such as treatment outcomes, use of GLP-1 in type 1 diabetes, and the impact of continuous glucose monitors. T1D Exchange was selected for an ADA Presidents' Select Abstract focusing on pediatric diabetes management. They also introduced the ADEPT Health Equity Conference, aiming to address disparities in diabetes care, reflecting their commitment to advancing health equity in diabetes management through collaborative efforts and data-driven insights.

CONFERENCES
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Jun 11,2024

Sequel Med Tech study backs its automated insulin pump that prevents occlusions

Sequel Med Tech's twiist automated insulin delivery system powered by Tidepool, evaluated in a recent study, demonstrated superior performance in detecting occlusions faster compared to three other commercial insulin pumps in the U.S. The study highlighted twiist's ability to prevent "silent insulin non-delivery" by using an acoustic sensor to measure insulin delivery volume in real-time. FDA-cleared in March, twiist detected occlusions between five and 30 times faster than competitors, with significantly lower pressure at occlusion points, reducing the risk of insulin delivery interruptions and site leakage.

CLINICAL STUDY

#insulin pump

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Jun 21,2024

Senseonics expects a Q4 launch for 365-day CGM, offers full-year outlook

Senseonics, based in Germantown, Maryland, provided updates at the American Diabetes Association Scientific Sessions regarding its Eversense E3 implantable continuous glucose monitor (CGM). The company anticipates FDA clearance for its next-generation 365-day CGM with once-per-week calibration by the fourth quarter of 2024, following its FDA integrated CGM designation received earlier. Senseonics expects substantial year-over-year sales growth in 2024, projecting revenues between $22 million and $24 million, driven by increased patient starts and expanded global deployment of its CGM technology. The company also highlighted its partnership with Mercy Health for health system integration, aiming to enhance its market presence and operational scale.

PRODUCT

#cgm

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