Jun 21,2024

New MiniMed 780G system data demonstrates ability to address persistent blood sugar challenges for people with type 1 diabetes

Medtronic plc presented new data at the American Diabetes Association's 84th Scientific Sessions highlighting the benefits of its MiniMed 780G system. The system, equipped with an advanced algorithm providing autocorrections every 5 minutes, showed significant improvements in managing hyperglycemia and reducing nighttime disruptions for people with type 1 diabetes. A retrospective analysis of real-world data (n=6026) demonstrated a substantial decrease in dawn phenomenon rates from 12.2% to 4.5% when users transitioned from the MiniMed 770G to the MiniMed 780G system. Time in Range also increased significantly, from 87.7% to 91.4% from midnight to 6 a.m. The next iteration of the MiniMed™ 780G system, combined with the Simplera Sync™ sensor, showed promising results in clinical outcome metrics like Time in Range and Time Above Range compared to other delivery methods.

CLINICAL STUDY

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Jun 20,2024

Insulet fully launches Omnipod 5 with Dexcom G7 in the U.S. along with iPhone app

Insulet has launched its Omnipod 5 system with Dexcom G7 CGM across the United States, marking the first FDA-cleared tubeless automated insulin delivery system that communicates with a CGM. This system proactively manages blood sugar levels by adjusting insulin doses to correct highs and prevent lows. Insulet also introduced a limited release of the Omnipod 5 App for iPhone, enhancing user control and convenience. The company expanded Omnipod 5 availability in Europe, including a launch in France with compatibility for Dexcom G6 and Abbott FreeStyle Libre 2 Plus sensors, aiming to broaden access to advanced diabetes management solutions globally.

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Jun 13,2024

GLUCOTRACK REPORTS SUCCESSFUL COMPLETION OF FIRST REPORTED LONG-TERM PRECLINICAL STUDY OF ITS EPIDURAL GLUCOSE MONITORING SENSOR

Glucotrack has announced the successful completion of a 60-day long-term preclinical study for its epidural continuous glucose monitoring sensor. The study demonstrated the sensor's ability to accurately monitor glucose levels in the epidural space, aligning closely with readings from traditional blood glucose monitors and subcutaneous CGMs. Throughout the study, no abnormal clinical signs or tissue reactions were observed, affirming the safety and reliability of the implanted sensor. Glucotrack plans to further develop this technology aimed at simplifying disease management for patients with painful diabetic neuropathy, potentially integrating it with existing treatments in the future.

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Jun 10,2024

ABBOTT RECEIVES U.S. FDA CLEARANCE FOR TWO NEW OVER-THE-COUNTER CONTINUOUS GLUCOSE MONITORING SYSTEMS

Abbott has received FDA clearance for two new over-the-counter continuous glucose monitoring (CGM) systems: Lingo and Libre Rio. Lingo is designed for consumers seeking to improve overall health and wellness, providing personalized insights and coaching based on continuous glucose data. It targets metabolic health improvement by tracking glucose levels and lifestyle factors. Libre Rio, Abbott's first OTC CGM for adults with Type 2 diabetes not using insulin, focuses on managing diabetes through lifestyle modifications. Both systems utilize FreeStyle Libre technology and aim to enhance health outcomes by empowering users with actionable glucose data.

REGULATORY FDA

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Jun 03,2024

Abbott receives FDA OK for over-the-counter glucose monitor

Abbott has received FDA approval for its over-the-counter glucose monitor, Lingo, which first launched in the U.K. last year. The device is designed for non-diabetics to track glucose spikes. With this clearance, Abbott joins the market alongside Dexcom, which received similar FDA approval for its CGM, Stelo, in March. Abbott has yet to announce the rollout details for Lingo in the U.S.  Abbott plans to market Lingo under a direct-to-consumer, cash-pay model that doesn’t need a prescription.

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Jun 05,2024

GLUCOTRACK ANNOUNCES 90-DAY PRECLINICAL STUDY RESULTS THAT DEMONSTRATE SUSTAINED ACCURACY OF ITS IMPLANTABLE CONTINUOUS BLOOD GLUCOSE MONITOR

GlucoTrack, Inc. announced successful results from a 90-day preclinical study of its Continuous Blood Glucose Monitor (CBGM), demonstrating sustained accuracy with a Mean Absolute Relative Difference (MARD) of 4.7%, indicating high precision. The CBGM offers a simplified, discreet, and less intrusive method for continuous glucose monitoring, directly measuring blood glucose in real-time, unlike subcutaneous sensors. The study, which included more subjects and a longer duration than previous studies, validated the device's performance without significant adverse effects. GlucoTrack plans to start human clinical trials later this year, aiming to enhance the quality of life for people with diabetes by providing a convenient monitoring solution.

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Jun 04,2024

Dexcom Wins Access to Dexcom One for 100,000 People Living With Type 2 Diabetes

Dexcom announced a significant advancement in access to its products for those treating Type 2 diabetes (T2D) with basal insulin injections. The company has secured access to its Dexcom ONE sensor for around 100,000 T2D users in France. The reimbursement guidance offers people aged over two years who are on non-intensified insulin therapy (less than 3 injections a day) and whose glycaemic control is insufficient (HbA1c ≥ 8%) access to Dexcom’s technology. The French government is the first in Europe to offer full national reimbursement for Dexcom CGM technology to those treating T2D with basal injections, following other countries around the world such as the USA and New Zealand.

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Jun 05,2024

Dexcom G7 Now Connects Directly to Apple Watch in the U.S.

DexCom announced that the Dexcom G7 Continuous Glucose Monitoring (CGM) System now connects directly to Apple Watch in the United States. Dexcom G7 is the first and only CGM available with Direct to Apple Watch, offering users the freedom and convenience of real-time glucose readings on their wrist even when their iPhone isn’t with them. In addition to the benefits of using Direct to Apple Watch with Dexcom G7, people with diabetes can track other key health metrics that can impact glucose levels using Apple’s Activity, Cycle Tracking, Sleep, and other health features on Apple Watch, iPhone and iPad. All of this data is stored securely in the Health app, where it can be viewed alongside Dexcom G7 data users choose to store in the Health app so all of their diabetes health information is accessible in one place.

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May 29,2024

Tandem Mobi Insulin Pump Now Compatible with Dexcom G7 CGM

Tandem Diabetes Care and Dexcom have announced that the Tandem Mobi insulin pump, which features Control-IQ technology, is now fully compatible with both the Dexcom G6 and G7 Continuous Glucose Monitoring (CGM) systems. Launched in the US earlier this year, the Tandem Mobi is the world's smallest automated insulin delivery (AID) system. This integration makes Tandem the only company offering two insulin pump options that work with both Dexcom G6 and G7, enhancing user choice in diabetes management. Current Tandem Mobi users in the US will receive a software update for this feature, available free of charge, while new customers will receive pumps with the updated software.

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Nov 29,2022

Dexcom, Abbott ask for another trial in CGM patent spat

Abbott and Dexcom are seeking a new trial in their ongoing patent dispute over continuous glucose monitors (CGMs). In March, a Delaware court found Dexcom violated one of Abbott's patents related to its FreeStyle Libre sensors but did not infringe on two others, with one patent deemed invalid. Despite the court's decision for a future trial to assess damages, both companies now seek broader judgments. Abbott claims Dexcom's failure to redesign its G6 CGM constitutes willful infringement, while Dexcom argues that Abbott's closing arguments prejudiced the jury. Both sides prefer Judge Kent A. Jordan to rule in their favor. The case includes other ongoing litigation in Europe.

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