Apr 21,2023

FDA Approves Medtronic MiniMed™ 780G System - World's First Insulin Pump with Meal Detection Technology* Featuring 5-Minute Auto Corrections†§

Medtronic announced U.S. FDA approval of its MiniMed™ 780G system with the Guardian™ 4 sensor requiring no fingersticks while in SmartGuard™ technology. The system provides insulin to help account for when users occasionally forget to bolus or underestimates the number of carbs in their meal. This milestone marks the approval of the only system with meal detection technology that provides automatic adjustments and corrections to sugar levels every 5 minutes

REGULATORY FDA

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Apr 19,2023

Senseonics announces first pediatric 365-day CGM insertion

The insertion took place as part of the company’s ENHANCE clinical trial at the AMCR Institute. AMCR, a clinical research center, focuses on pre-diabetes, type 1, type 2 diabetes and obesity. The study operates under the direction of Dr. Timothy Bailey. Dr. Francine Kaufman, Senseonics CMO, said expanding to a pediatric population represents a “priority” for the company.

CLINICAL STUDY

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Apr 17,2023

ABBOTT'S FREESTYLE LIBRE® CONTINUOUS GLUCOSE MONITORING SYSTEMS OBTAIN SIGNIFICANTLY EXPANDED COVERAGE FOR MEDICARE BENEFICIARIES

The Medicare program has expanded access to continuous glucose monitoring systems like the FreeStyle Libre 2 system and the FreeStyle Libre 14 day system for insulin-using Medicare beneficiaries with diabetes, removing the prior requirement of multiple daily insulin injections. More Medicare beneficiaries than ever before who are living with diabetes and use insulin will now be eligible for reimbursement when using Abbott's FreeStyle Libre® portfolio. The U.S Food and Drug Administration (FDA) just cleared a reader for the FreeStyle Libre 3 system. With the FDA's clearance of a standalone reader, Abbott is working to get the FreeStyle Libre 3 system added to Medicare's list of covered systems as soon as possible.

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Apr 17,2023

Dexcom Commends Decision to Expand CGM Medicare Coverage to Include People With Diabetes Using All Types of Insulin

Medicare patients using all types of insulin now have coverage for Dexcom G7– giving approximately 1.5 million more Americans access. The updated Medicare policy is the biggest single expansion of CGM coverage in the U.S. to date. Results from the 2021 MOBILE study, sponsored by Dexcom and using Dexcom CGM, served as the primary piece of clinical evidence that led to this coverage expansion by demonstrating that CGM use significantly improves A1C and increases time in range for adults with Type 2 diabetes on basal insulin.

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Apr 17,2023

Tandem Diabetes Care Announces Control-IQ Technology Meta-analysis Demonstrating Positive Clinical Impact of Automatic Correction Bolusing on Glucose Control in People with Type 1 Diabetes

Tandem Diabetes Care announced publication by Diabetes Technology & Therapeutics of a meta-analysis of three randomized controlled trials of its Control-IQ advanced hybrid closed-loop technology. The analysis showed an average increase in time in range of 2.8 hours and a reduction in hemoglobin A1c compared to control groups in people ages 2 to 72 years old. People with the highest baseline blood sugar levels experienced the greatest benefit from the auto-bolus feature of the Control-IQ algorithm. Improvements in time in range for subjects using Control-IQ technology (n=256) were immediate, sustained, and observed across the spectrum of patient characteristics including age, race-ethnicity, parental education, family income, baseline glycated hemoglobin level, virtual vs. in-person training format, and pre-study insulin delivery method. The majority of the control group (n=113) used an insulin pump (91%), some with predictive low glucose suspend technology.

CLINICAL STUDY

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Apr 14,2023

FDA CLEARS READER FOR ABBOTT'S FREESTYLE LIBRE® 3 SYSTEM

Abbott today announced that the U.S. FDA has cleared a reader for its FreeStyle Libre® 3 integrated continuous glucose monitoring (iCGM) system. With the FDA's clearance of a standalone reader, Abbott is working to get the FreeStyle Libre 3 system added to Medicare's list of covered systems as soon as possible.

REGULATORY FDA

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Apr 03,2023

ABBOTT ISSUES SAFETY NOTIFICATION FOR FREESTYLE LIBRE® FAMILY OF READERS IN THE U.S.

Abbott initiated a voluntary medical device correction in February to emphasize instructions for its FreeStyle Libre®, FreeStyle Libre® 14 day and FreeStyle Libre® 2 Readers in the United States due to a limited number of reports worldwide from users over several years that their reader’s lithium-ion battery swelled, infrequently overheated or, in very rare cases, sparked or caught fire.

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Apr 02,2023

An Integrated Digital Health Care Platform for Diabetes Management With AI-Based Dietary Management: 48-Week Results From a Randomized Controlled Trial

Researchers investigated the efficacy of an integrated digital health care platform with artificial intelligence (AI)–based dietary management in adults with type 2 diabetes (T2D). In this 48-week, open-label, randomized, multicenter clinical trial, overweight or obese adults with T2D were randomly assigned to one of three groups in a 1:1:1 ratio: group A received routine diabetes care; group B used the digital integrated health care platform by themselves; and group C used the platform with feedback from medical staff and intermittently applied personal continuous glucose monitoring. The decreases in HbA1c from baseline to 24 and 48 weeks in group B and group C were significantly larger than those in group A. Among adults with T2D, use of an integrated digital health care platform with AI-driven dietary management resulted in better glycemia and more weight loss.

CLINICAL STUDY

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Mar 30,2023

Bigfoot Biomedical acquires insulin titration algorithm developed at McGill University

Bigfoot Biomedical announced today that it acquired a reinforcement learning algorithm for insulin titration from McGill University. Developers at McGill designed the algorithm to observe how well people with insulin-requiring diabetes respond to a particular dose. It provides a recommended adjustment based on the body’s response. Less than two years ago, Bigfoot Biomedical launched its Bigfoot Unity platform in some U.S. states. Last year, Brewer called it a “transformational attempt” to simplify CGMs and the data they produce to tell people how much insulin to take at a given point in time. Just last month, the company made another play to further enhance this platform. Bigfoot sold pump-based automated insulin delivery technology patents to pump maker Insulet for $25 million. This asset sale generated significant funds to expand the Bigfoot Unity diabetes management system. The company said it aims to expand access by offering Bigfoot Unity through the pharmacy channel later this year.

PRODUCT

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Mar 27,2023

Canada Diabetes Market Analysis, Size, & Forecasts Report 2023: A $1.53 Billion Market by 2028

Canada's Diabetes Market will reach US$ 1.53 Billion by 2028 with a CAGR of 3.85% during the forecast period (2023-2028). The only drawback that might affect the Canadian diabetes industry growth is the high cost of insulin pens, according to the publisher. Canadian diabetes market was valued at US$ 1.22 Billion in 2022.

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