Sep 05,2024 TOP STORY

ABBOTT'S LINGO™ CONTINUOUS GLUCOSE MONITOR FOR HEALTH AND WELLNESS NOW AVAILABLE IN THE U.S.

Abbott announced U.S. availability of Lingo™, the company's first continuous glucose monitoring system available without a prescription. The Lingo system includes a biosensor and a mobile app designed for consumers who want to improve their overall health and wellness. Lingo is based on Abbott's FreeStyle Libre continuous glucose monitoring technology, now used by more than 6 million people with diabetes globally. Abbott's consumer biowearable, Lingo, is available for consumers 18 years and older not on insulin. Lingo tracks glucose in real-time and provides personal insights and coaching to help people build healthy habits, retrain their metabolism and improve their overall well-being. The biosensor can be worn on the back of the arm for up to 14 days.

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Aug 07,2024

Medtronic announces FDA approval of Simplera CGM

Medtronic announced FDA approval for its Simplera continuous glucose monitor (CGM), its first disposable, all-in-one CGM that's half the size of previous models, designed for easier insertion and wear without overtape. The Simplera™ platform includes the Simplera CGM and the Simplera Sync™ sensor, which integrates with Medtronic's MiniMed 780G system and will eventually work with the InPen™ smart insulin pen.

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Jun 24,2024

Trinity Biotech to Begin European Pre-Pivotal Trial to Optimize its CGM Sensor

Trinity Biotech has announced progress on its next-generation continuous glucose monitoring (CGM) solution, following its acquisition of CGM technology earlier this year. The company has received regulatory approval to start a European pre-pivotal trial, which will assess the enhanced performance of the CGM device. This trial, expected to finish by the end of July, will provide data to optimize the device before a larger pivotal trial planned for 2025.

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Jul 08,2024

A Glycemic Status Classification Model Using a Radiofrequency Noninvasive Blood Glucose Monitor

A new peer-reviewed study published by Know Labs in Diabetes Technology and Therapeutics Journal aimed to assess Know Labs' noninvasive blood glucose measurement method for classifying glycemic status using a novel radiofrequency (RF) glucose sensor combined with machine learning. Data were collected from 31 participants with prediabetes or type 2 diabetes using both the RF sensor and traditional glucose meters. The results showed that the machine learning model achieved an overall accuracy of 93.37% in classifying glycemic status. Specifically, the model demonstrated sensitivities of 85.51% for hyperglycemic, 96.63% for normoglycemic, and 50.00% for hypoglycemic statuses. The specificities were 96.92% for hyperglycemic, 84.51% for normoglycemic, and 99.81% for hypoglycemic statuses. These findings suggest that the RF sensor, in conjunction with machine learning, can effectively classify glycemic status, indicating its potential for noninvasive diabetes screening.

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Jul 09,2024 TOP STORY

Roche receives CE Mark for its AI-enabled continuous glucose monitoring solution

Roche announced today that it has received the CE Mark for its Accu-Chek SmartGuide continuous glucose monitoring (CGM) solution with 14-day wear time. This significant milestone paves the way for the solution to be made available to people living with type 1 and type 2 diabetes over the age of 18 on flexible insulin therapy. Every five minutes, the Accu-Chek SmartGuide CGM sensor sends glucose values measured in real time to the Accu-Chek SmartGuide app. The Accu-Chek SmartGuide Predict app then utilises those glucose values and other available information to detect glucose patterns and predict future glucose levels. Its integrated AI-enabled predictive algorithms indicate hypoglycaemia risk within the next 30 minutes, continuously forecast how glucose levels will develop within the next two hours, and estimate the risk of nocturnal hypoglycaemia. The Accu-Chek SmartGuide solution seamlessly integrates with the Accu-Chek Care platform, offering healthcare professionals access to comprehensive therapy-relevant data provided by the CGM solution.

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Jul 06,2024

Over-the-counter continuous glucose monitors empower diabetes patients and refine clinical insights | Viewpoint

Lucienne Ide, CEO of Rimidi, discusses the transformative impact of FDA-approved over-the-counter (OTC) continuous glucose monitors (CGMs) like Dexcom's Stelo Glucose Biosensor. This approval marks a significant advancement in diabetes management, allowing broader access to detailed glucose monitoring without the need for prescriptions or insurance, thus empowering patients. Ide highlights the shift from sporadic glucose level checks to continuous monitoring, providing comprehensive data for better disease management. Widespread adoption hinges on educational efforts to help patients and providers understand the value of CGMs. The ultimate goal is not just data collection but enhancing health management and outcomes, striving for national health equity.

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Jun 04,2021

Carbon Health Acquires CGM-Enabled Virtual Diabetes Platform Steady Health

Carbon Health has acquired Steady Health, a diabetes platform utilizing continuous glucose monitoring (CGM) data for personalized care by top endocrinologists. This acquisition enhances Carbon Health's primary care model by integrating its clinic network with virtual and hardware-enabled services for a comprehensive healthcare experience. Financial terms were not disclosed. Additionally, Carbon Health appointed Myoung Cha, former Apple Health head, as Chief Strategy Officer (CSO) and President of Home-Based Care, and Nita Sommers, former Honor president, as Chief Growth Officer (CGO). Cha will expand device-enabled home care operations, including virtual care, remote monitoring, and home diagnostics, while also advancing the company's omnichannel care model. Sommers will grow Carbon Health’s services in mental health, pediatrics, and value-based offerings for employers and payers.

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Jun 21,2024

Dexcom's G6 CGM System Combines With AID in Netherlands

Dexcom recently announced the integration of its Dexcom G6 Continuous Glucose Monitor (CGM) system with Insulet’s Omnipod 5 Automated Insulin Delivery (AID) System for Type 1 diabetes patients in the Netherlands for an easier diabetes management experience. The combination system is intended to improve patient's quality of life by providing greater mobility without the concern of dislodging tubes. It is the first Hybrid Closed Loop (HCL) system without tubes to be authorized for use in children in the Netherlands.

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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.

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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.

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