Feb 06,2024

Dexcom Launches Dexcom One+ Bringing Powerful, New Diabetes Management Technology to More People

Dexcom announced the launch of their latest CGM system, Dexcom ONE+. The system is available now in Spain, Belgium, and Poland and launches next week in the Netherlands. Additional countries in Europe, the Middle East and Africa will be announced in the following months. In some countries Dexcom ONE+ replaces the previous generation Dexcom ONE sensor. The company also incorporated feedback from both end users and healthcare professionals when building Dexcom ONE+, ensuring an easy-to-use, highly effective, CGM experience for people treating their Type 1 or Type 2 diabetes with insulin.

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Feb 06,2024

PHC Holdings Corporation and Senseonics Announce Appointment of Brian Hansen as President of CGM at Ascensia Diabetes Care

PHC Holdings Corporation, the parent company of Ascensia Diabetes Care along with Senseonics Holdings, Inc., announced that diabetes industry veteran Brian Hansen has been appointed to the newly created role of President of CGM at Ascensia Diabetes Care, effective February 6, 2024. Ascensia is the exclusive global distributor of the Eversense® E3 CGM system developed and manufactured by Senseonics. Mr. Hansen will be responsible for the global commercialization and growth of the innovative Eversense CGM, currently available in the U.S. and select European markets.

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Feb 07,2024

Insulet Announces CE Mark Approval of Omnipod® 5 Integration with Abbott FreeStyle Libre 2 Plus Sensor

Insulet Corporation announced it has received CE mark approval under the European Medical Device Regulation for the added compatibility of the Abbott FreeStyle Libre 2 Plus sensor with Insulet’s Omnipod 5 Automated Insulin Delivery System for individuals aged two years and older with type 1 diabetes. Insulet expects Omnipod 5 integration with the Abbott FreeStyle Libre 2 Plus sensor to be available first in the United Kingdom and Netherlands in a phased launch in the first half of 2024, with additional markets to follow.

REGULATORY CE MARK

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Jan 19,2024

Modular Medical submits next-gen insulin pump for FDA clearance

Modular Medical announced that it submitted its next-generation MODD1 insulin pump to the FDA for 510(k) clearance. Modular Medical designed the 90-day MODD1 with new microfluidics technology to allow for the low-cost pumping of insulin. The pump has a reservoir size of 300 units/3mL. Users can monitor the pump activity with their cell phone and do not require an external controller. CEO Jeb Besser said the company expects initial questions from the FDA during the quarter ending June 30, 2024. While it works with the FDA, the company plans to prepare applications to garner marketing approval in the UK.

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Jan 25,2024

BIOCORP Obtains 510(k) FDA Clearance for SoloSmart®, Sanofi’s Smart Cap for Disposable Insulin Pens

BIOCORP, a Novo Nordisk company based in France and specialized in the design, development, and manufacturing of innovative medical devices, announced that they have received 510(K) clearance from the U.S. Food & Drug Administration (FDA) to market SoloSmart®, Sanofi’s smart medical device that connects SoloStar® insulin pens. Designed, developed, and manufactured exclusively for Sanofi by BIOCORP, SoloSmart is a smart sensor that is directly attached to Sanofi’s SoloStar insulin pen platform, upgrading the pens into connected devices. It offers HCPs an easy way to follow patients in the case of a multitherapy treatment, for instance when using basal and rapid insulins. In addition to SoloSmart's CE marking (Sept 2022), the FDA’s authorization reinforces BIOCORP's technological leadership in the smart pens market. Previously, BIOCORP obtained 510(k) clearance for Mallya first version in December 2022.

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Jan 30,2024

Glytec Announces Major Expansion of Executive Team to Drive Innovation and Growth

Glytec, a provider of cloud-based insulin management software as a service (SaaS) solutions across the continuum of care, proudly announces the addition of key healthcare leaders to its executive team to continue to scale the company, grow its client base, and meet the needs of the growing healthcare industry and diabetes technology market. Erik Eaker, taking on the role of Chief Operating Officer (COO), previously held international and domestic executive positions at Humana and led operations during the growth and exit of a privately held digital health company to Ireland-based LetsGetChecked where he was SVP of Business Operations. Ashley Reynolds, PhD, MSN, RN, has joined as Chief Product and Experience Officer and brings over 30 years of healthcare experience including C-suite roles where he helped grow and exit multiple healthcare technology companies. Matt McPherson, who recently joined as Chief Financial Officer (CFO) of Glytec, has more than 20 years of leadership in the healthcare and software-as-a-service (SaaS) technology sectors.

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Feb 01,2024

Mesh Bio bags $3.5M to bring digital twin tech to Hong Kong, Indonesia, Philippines

Singaporean startup Mesh Bio has raised $3.5 million in a Series A funding round led by East Ventures. The round was also participated by Elev8, Seed Capitals, and its other shareholders. Mesh Bio has a targeted focus on both Indonesia and the Philippines where chronic diseases are said to be most prevalent and deadly. In a statement, the company said it will use its fresh funds to scale the deployment of its solutions, particularly its flagship digital twin offering, across Hong Kong and Southeast Asia. The latest funding raise comes three months after Mesh Bio secured a regulatory clearance from Singapore’s Health Sciences Authority for HealthVector Diabetes. The digital twin-based software-as-a-medical device can predict a 3-year onset risk of chronic kidney disease in patients with type 2 diabetes by using clinical data pulled from hospital EMRs. The digital twin solution, which is an expanded offering on Mesh Bio's DARA Health Intelligence Platform, is now being trialled at Singapore General Hospital, Tan Tock Seng Hospital, and selected polyclinics in Singapore.

FUNDING SERIES A
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Feb 05,2024

NHS Scotland plans digital diabetes prevention

NHS Scotland is planning to set up a Digital Diabetes Prevention Progamme, using digital technology in clinical interventions. Its Commons Services Agency – otherwise known as NHS National Services Scotland (NSS) – has published a prior information notice for potential suppliers on the plan, indicating that it is expected to support around 2,000 people in its first year then 1,400 annually over the next two years. “The programme will seek to provide a proven clinical intervention using digital technology that will provide support over a nine-month period, using trained lifestyle coaches to enable participants to track progress against their own goals via a digital application,” the notice says.

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Feb 01,2024

Long Term Results of a Digital Type 2 Diabetes Program from Omada Health

A new study from Omada Health aimed to examine the long-term impact of a digital diabetes self-management education and support (DSMES) program on A1C among adults with type 2 diabetes (T2DM). Data analyzed were from a retrospective cohort of commercially insured members with T2DM enrolled in the Omada for Diabetes program between January 1, 2019, and January 31, 2022 (n=1,322). The study measured changes in A1C and weight across 12?months (collected at baseline and every 3 months over 1 year) overall and stratified by A1C at baseline (8% vs <8%). The results showed a real-world evidence that members with elevated baseline A1C (8%) enrolled in a digital DSMES program experienced clinically meaningful and statistically significant reductions in A1C. Members with baseline A1C 8% demonstrated clinically and statistically significant adjusted mean reductions in A1C during follow-up, from 9.48% at baseline to 7.33%, 7.57%, 7.59%, and 7.47% at 3, 6, 9, and 12 months, respectively. Those with A1C <8% maintained glycemic stability. Collectively, members experienced a 1.17kg/m2 mean reduction in BMI over 12 months.

CLINICAL STUDY
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Feb 02,2024 TOP STORY

How Kakao Healthcare's latest AI-powered mobile diabetes app works

Kakao Healthcare has unveiled its latest AI-driven mobile diabetes management app. Called PASTA (Personalised, Accessible, Supportive, Tech-enabled, and Affordable), the app currently links to two CGM devices: CareSens Air by local manufacturer i-SENS and Dexcom's G7. The app will also pair with the Mallya smart cap for insulin pens by the second quarter. Once the CGM device is linked, the app automatically displays details about the user's blood sugar in real-time via Bluetooth. It also allows users to record their meals, exercise, insulin doses, and medication. The app features vision AI that automatically provides information about nutrition, calories, and food types of their meals. Another feature is a handy summary report of the user's blood sugar reading with indicators pointing out which ones are good and bad. These summaries are also made available for sharing with the user's family. It can also provide a guide to managing blood sugar levels and creating healthy lifestyle habits. Meanwhile, Kakao Healthcare developed Pasta Connect Pro, a dashboard for doctors where they can check their patients' blood sugar trends and lifestyle changes in near real time. It is planned to be linked with hospital EMRs to provide convenience of data input to staff and patients.

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