Medtronic Diabetes announces CE Mark for new Simplera™ CGM with disposable all-in-one design

Medtronic today announced CE Mark approval for its new all-in-one, disposable Simplera continuous glucose monitor (CGM) featuring a simple, two-step insertion process. The company's newest no-fingerstick sensor does not require over tape and is seamlessly integrated with the InPen smart insulin pen, which provides real-time dosing guidance. Medtronic will begin a phased launch at the European Association for the Study of Diabetes (EASD) 59th Annual Meeting in Hamburg, Germany on Oct. 2-6, 2023. "Despite the rapid adoption of CGM over the past decade, less than 30% of individuals on MDI therapy using a CGM achieve glycemic targets — highlighting a significant unmet need. We're excited to help more people to reach their goals with our advanced algorithm in InPen™ powered by our smallest and most comfortable CGM to-date," said Que Dallara, EVP and President, Medtronic Diabetes. Simplera is indicated for ages 2+ and is not approved by the FDA. Medtronic's automated insulin delivery (AID) system integrated with this next-generation sensor is currently under review for CE Mark and is not commercially available in the U.S. or in Europe.

Hybrid Closed-Loop Therapy in Adults With Type 1 Diabetes and Above-Target HbA1c: A Real-world Observational Study

This study explored the impact of switching to hybrid closed-loop (HCL) insulin delivery systems in adults with type 1 diabetes who had elevated HbA1c levels despite using intermittently scanned continuous glucose monitoring (isCGM) and insulin pump therapy. They conducted an observational study involving 570 HCL users across 31 diabetes centers in England. This study demonstrates that HCL insulin delivery systems can lead to significant improvements in glycemic control, reduced hypoglycemia, enhanced quality of life, and high patient satisfaction among adults with type 1 diabetes, even in real-world settings. The results showed significant improvements, including: The mean adjusted HbA1c decreased by 1.7% after switching to HCL, and TIR (glucose levels between 70–180 mg/dL) increased from 34.2% to 61.9%.

Real-world Accuracy of CGM in Inpatient Critical and Noncritical Care Settings at a Safety-Net Hospital

The study aimed to assess the real-world accuracy of inpatient continuous glucose monitoring (CGM) at various levels of patient acuity in a large safety-net hospital. The research involved analyzing data from hospitalized patients who used Dexcom G6 CGM devices, comparing CGM glucose readings with both point of care (POC) and laboratory (Lab) glucose measurements. The patients were categorized as not critically ill (NCI) or critically ill (CI). The study found that CGM accuracy was acceptable in both NCI and CI patients, with the accuracy being slightly better when compared to Lab glucose readings than POC readings. The analysis also revealed that certain unique patient conditions, such as anorexia nervosa, hypoglycemia disorders, and specific medical interventions, could affect CGM accuracy. Overall, the study suggests that inpatient CGM can be a valuable tool for glucose management, especially when used in a critical care setting, but further research is needed to explore its limitations and benefits in real-world scenarios.

Dexcom Canada and RxFood Corporation Partner on AI-powered Nutrition and Glucose Monitoring Solution for Diabetes Management

Dexcom, Inc., a global leader in real-time continuous glucose monitoring (rtCGM) for people with diabetes, and RxFood Corporation, the leader in AI-driven personalized nutrition assessments, announced today their partnership in Canada to introduce an improved digital health solution for those living with diabetes. Within the RxFood app, Dexcom CGM users can capture photos of their meals, eliminating the need for manual food and nutrition tracking. As they photo-log their food, RxFood will continuously generate detailed diet quality metrics that are combined with glucose data, making it easily accessible to both patients and their dedicated clinicians. The combination of RxFood with Dexcom CGM addresses the need for unified, time-matched food and glucose data reports to effectively manage diabetes and enable personalized nutritional guidance at scale.

Kakao Healthcare, i-SENS to enhance diabetes care through CGM, digital health services

Kakao Healthcare and i-SENS said they have signed a contract to cooperate in the supply of continuous glucose monitoring (CGM) devices and data linkage-based blood glucose management services. The two companies have been discussing cooperation since July last year and had signed a memorandum of understanding for cooperation in the chronic disease management business in January this year. Under the accord, the two companies plan to provide innovative digital healthcare services by combining Kakao Healthcare's platform and artificial intelligence capabilities with i-SENS's biosensor expertise, including CGM devices. Also, i-SENS will supply its CGM device, CareSens Air, to Kakao Healthcare, which will then distribute the product through its platform.

Dexcom G6 Strengthens Its Position as World’s Most Connected CGM System With a New Aid Offering in Germany

DexCom, Inc., global manufacturer of systems for real-time continuous glucose monitoring for people with diabetes, today announced the Dexcom G6 Real-Time Continuous Glucose Monitoring System (rt-CGM) is the first and only CGM to connect to the Omnipod 5 AID System in Germany, helping users to protect against high and low glucose levels. “At Dexcom we believe that diabetes technology should be built to celebrate and support the diabetes community. This launch gives Dexcom users in Germany another choice in automated insulin delivery systems, adding to the company’s existing insulin delivery collaborations with Tandem, Ypsomed and CamDiab. We are delighted to see years of close collaboration with industry partners result in giving people with diabetes unparalleled choice, peace of mind and better clinical outcomes,” said Alexander Fröhlich, Vice President for Germany, Austria, Switzerland, and Slovenia at Dexcom.

ABBOTT AND WEIGHTWATCHERS CONNECTED APP EXPERIENCE IS NOW AVAILABLE FOR PEOPLE LIVING WITH DIABETES

Abbott and WW International, Inc., known as WeightWatchers, announced today the availability of a connected app to help people living with diabetes understand how food and activity impact their glucose levels. WeightWatchers members who follow the WW Diabetes-Tailored Plan can now access their glucose data from Abbott's FreeStyle Libre 2, a continuous glucose monitoring (CGM) system, within their WW app while being guided by the WW Diabetes-Tailored Plan. From now until Dec. 31, 2023, new WW members can enjoy a free month of the WeightWatchers Diabetes-Tailored Plan and connect the WW app with the FreeStyle Libre 2 system. Any new FreeStyle Libre 2 users may be eligible to receive a voucher for a free trial of the FreeStyle Libre 2 system when they sign up for the MyFreeStyle Libre program.

ABBOTT TO ACQUIRE BIGFOOT BIOMEDICAL, FURTHERING EFFORTS TO DEVELOP PERSONALIZED, CONNECTED SOLUTIONS FOR PEOPLE WITH DIABETES

Abbott (NYSE: ABT) and Bigfoot Biomedical today announced a definitive agreement for Abbott to acquire Bigfoot, a leader in developing smart insulin management systems for people with diabetes. The transaction is subject to customary closing conditions and is expected to close in the third quarter of 2023. Financial terms were not disclosed. 

Abbott and Bigfoot have worked together on connected diabetes solutions since 2017. Bigfoot developed Bigfoot Unity®, a smart insulin management system that features the first and only FDA-cleared connected insulin pen caps that use integrated continuous glucose monitoring (iCGM) data along with healthcare provider instructions to provide insulin dosing recommendations. The dosing recommendations are displayed on the pen cap's digital screen to help people know how much insulin to take. The Bigfoot Unity system exclusively works with Abbott's world-leading FreeStyle Libre® technology and includes a customer smartphone app connected to a cloud-based online portal used by healthcare providers to support their patients, including through remote care.

Nemaura Medical Completes 100 Patient Study for sugarBEAT® 24-hour Wear and Reports Interim Results

Nemaura Medical , a medical technology company focused on developing and commercializing non-invasive wearable sensors and supporting personalized diabetes management and metabolic health programs, today announced it has recently completed a 100-patient study across 4 cohorts of 25 diabetic patients for sugarBEAT® and provided interim results. This study was designed to evaluate several factors, including the possibility of increasing the wear period to up to 24 hours, evaluating the possibility of auto-calibration, and different methods of application of the device to the skin. The study was conducted in the Middle East on 100 adult patients aged 18 to 75 comprising 20 persons with Type 1 diabetes and 80 persons with Type 2 diabetes. The Company reports interim data from a first cohort comprising 25 patients, on a single day sensor wear. The results indicate that a 24-hour sensor wear period using a single sensor is possible, which is expected to allow users to monitor their glucose fluctuations overnight.

Dexcom Unlocks Access to Real-Time CGM for a Further Half a Million People With Diabetes in France

DexCom, Inc. today announced the availability of its Dexcom ONE real-time CGM sensor via reimbursement, in France. Specifically, access is now secured to the Dexcom ONE sensor for all patients with type 1 and type 2 diabetes, two years and older, who are undergoing intensive insulin therapy (by external pump or >3 injections per day). “We believe this is truly exciting news for people living with diabetes in France,” said Gérald Zammit, Country Director of Dexcom France. "Access to Dexcom real-time CGM sensors is now available to those who live with diabetes, who aren’t necessarily seen as ‘high risk’, but who can still greatly benefit from it. The launch of Dexcom ONE in France will help to make real-time CGM accessible to as many patients as possible.”