May 30,2023

FDA green-lights bionic pancreas studied at UT Health Science Center San Antonio, University Health

The University of Texas Health Science Center at San Antonio and its clinical partner, University Health, have received FDA clearance for the "bionic pancreas," an AI-powered system that helps manage insulin delivery for children with type 1 diabetes. The system, paired with a continuous glucose monitoring system, relieves parents and children of the constant stress of estimating insulin doses and carbohydrate intake. The device, about the size of a cell phone, uses AI algorithms to learn the patient's insulin requirements, providing a simpler and more automated approach to diabetes management.

REGULATORY FDA

#closed loop

#cgm

View Analyst & Ambassador Comments
Go to original news
May 22,2023

Beta Bionics Announces FDA Clearance and Commercialization of the iLet Bionic Pancreas

Beta Bionics, Inc. — a medical technology company focused on diabetes — announces FDA 510(k) clearance and the commercial launch of the iLet Bionic Pancreas. The iLet is the first and only automated insulin-delivery system that does not require carb counting and fully automates 100% of all user insulin doses. The only input that is required to get started is the user’s weight. The iLet is paired with the Dexcom G6 Continuous Glucose Monitoring System.

PRODUCT

#closed loop

#cgm

View Analyst & Ambassador Comments
Go to original news
May 23,2023

New App From January.ai is an AI-Powered Health Coach, Uses Generative AI to Predict Blood Sugar Response to 32MM+ Foods

Precision health tech company, January AI, releases a new generative AI-enabled app that estimates and predicts individuals’ glucose response to 32 million foods, even when members are not wearing a continuous glucose monitor (CGM). Unlike a normal CGM, January AI predicts how food will impact a person's blood sugar, beyond only reporting what’s happened. “With January AI, members enter foods they are considering eating, and the predictive AI model will tell them what it will do to their blood sugar. It helps them make better decisions about what they’re about to put into their body, kind of like having an AI nutritionist in your pocket to let you know whether you should order'' said Noosheen Hashemi, who co-founded January AI in 2016 with Stanford University’s Director of Genomics, Dr. Michael Snyder, PhD. January AI is available now at app.january.ai for $288 for the first month ($28 monthly membership fee after).

PRODUCT

#mobile app

#cgm

View Analyst & Ambassador Comments
Go to original news
May 09,2023

ASCENSIA DIABETES CARE EXPANDS PAYMENT ASSISTANCE AND SIMPLE SAVINGS PROGRAM FOR EVERSENSE E3 CGM System

Ascensia Diabetes Care, a global diabetes care company, maker of the CONTOUR® Blood Glucose Monitoring (BGM) System portfolio and exclusive distributor of Eversense® Continuous Glucose Monitoring (CGM) Systems, announces that it has significantly expanded Eversense PASS, a Payment Assistance and Simple Savings program. Eligibility for the program has now been extended to all commercially insured people with diabetes across the country, including those who do not have coverage for the Eversense E3 system from their insurance provider. Additionally, new Eversense E3 users will now only pay $99 out of pocket for their first two Eversense E3 systems* extending the $99 introductory offer that was previously available for just the initial sensor and smart transmitter. This results in an out-of-pocket cost of less than $200 for an entire year of continuous glucose monitoring with Eversense E3 for new users. For each sensor thereafter, users will pay a maximum of $100 per month, or $600 for the six-month duration of each sensor.

PRODUCT

#cgm

View Analyst & Ambassador Comments
Go to original news
May 03,2023

Dexcom rtCGM is Likely to be Cost-Saving, Study Suggests

Dexcom announced today the publication of a study "Cost-Effectiveness of a Real-Time Continuous Glucose Monitoring System Versus Self-Monitoring of Blood Glucose in People with Type 2 Diabetes on Insulin Therapy in the UK" in Diabetes Therapy. The analysis suggests that, compared to finger pricks, use of rtCGM results in significant improvements in baseline glycated haemoglobin (HbA1c), as well as reductions in long-term diabetes-related complications and emergency department visits. Based on a willingness-to-pay threshold of £20,000 per quality-adjusted life year (QALY), the research found: 70.8% probability of rtCGM being cost-effective to the NHS compared to finger-pricking to test via a blood glucose meter and; 38.7% probability of rtCGM being cost-saving to the NHS as it can help decrease the risk of developing diabetes-related complications. The estimated yearly cost of diabetes to the NHS in 2022 is £10 billion – around 10% of its budget. rtCGM was associated with An incremental cost-effectiveness ratio of £3,684 per QALY versus testing with finger pricks.

CLINICAL STUDY

#cgm

View Analyst & Ambassador Comments
Go to original news
May 04,2023

Health Canada licenses Medtronic Guardian 4 CGM sensor for use with MiniMed 780G

Medtronic (NYSE:MDT) announced that it received a license from Health Canada for use of its Guardian 4 with the MiniMed 780G. The licensing enables the use of the next-generation continuous glucose monitor sensor with the next-generation automated insulin pump. MiniMed 780G with Guardian 4, an advanced, hybrid closed-loop system, helps users manage type 1 diabetes.

PRODUCT

#cgm

#insulin pump

#closed loop

View Analyst & Ambassador Comments
Go to original news
May 05,2023

Study supports feasibility of Know Labs non-invasive CGM

Know Labs (NYSE:KNW) today announced the results of a feasibility study comparing its glucose monitoring technology to the Dexcom G6 CGM. It’s presenting results today at the American Association of Clinical Endocrinology (AACE) Annual Meeting in Seattle. The company sought to validate the technical feasibility of its Bio-RFID sensor technology for quantifying blood glucose concentration (BGC). Its studies evaluated five healthy participants using the Dexcom G6 as a reference device. Participants placed their forearms on the Bio-RFID sensor and consumed liquid D-Glucose to stimulate a glucose spike. The study monitored BGC for three hours while simultaneously logging readings from the Bio-RFID sensor and the Dexcom G6. It collected data on a continuous basis. Know Labs then used the data from the Bio-RFID sensor to train the neural network model to predict the readings. Know Labs said its study resulted in a mean absolute relative difference (MARD) of 20.6%. It performed with 46% of predictions within the FDA’s recommended limit for accuracy for new blood glucose monitors.

CLINICAL STUDY

#cgm

View Analyst & Ambassador Comments
Go to original news
Apr 28,2023

Abbott FreeStyle Libre 3 authorized for automated insulin delivery in UK

Abbott announced that its FreeStyle Libre 3 continuous glucose monitor (CGM) received UK authorization for use in automated insulin delivery. Authorization enables FreeStyle Libre 3 — Abbott’s newest sensor — to work with the Ypsomed mylife YpsoPump and CamDiab’s CamAPS FX mobile app. The company called this a “major step forward” for type 1 diabetes management in the United Kingdom.

PRODUCT

#cgm

#closed loop

View Analyst & Ambassador Comments
Go to original news
Apr 27,2023

Dexcom G6 Real-Time CGM System Now Accessible to Any Eligible Client Managing Diabetes With Insulin Through NIHB

Dexcom applauds the progressive expansion of coverage for continuous glucose monitoring systems through the Non-Insured Health Benefits (NIHB) program. Dexcom G6 is now at its most accessible point ever under the NIHB program, making the highest degree of diabetes management possible for First Nations and Inuit peoples. Having more choice to use Dexcom CGM is pivotal, and this expansion brings people in Canada one step closer to accessing the technology they need.

PRODUCT

#cgm

View Analyst & Ambassador Comments
Go to original news
Apr 24,2023

Digital Diabetes Management Market Untapped Growth Opportunities Analysis

The global digital diabetes management market is estimated to reach over USD 35.15 billion by 2030, exhibiting a CAGR of 11.16% during the forecast period, according to the publisher. The market's strong growth is primarily due to the rising incidence of diabetes and technological improvement and innovation.

#bgm

#cgm

View Analyst & Ambassador Comments
Go to original news
Subscribe to CGM