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  • Dexcom's Stelo Cleared by FDA as Over-the-Counter

    Mar 6, 2024
    Stelo by Dexcom, the first glucose biosensor cleared by the FDA for over-the-counter use, will be available in the US for individuals aged 18 and older not using insulin therapy, making it accessible without a prescription. This small, wearable sensor, worn on the upper arm, will transmit glucose data directly to the user's smartphone. Developed by Dexcom, Stelo aims to empower people with Type 2 diabetes to manage their health effectively. Available from summer 2024 onwards, Stelo fills a crucial gap in the market, providing continuous glucose monitoring for those without insurance coverage or prescription access.
  • Modular Medical submits MODD1 insulin pump for FDA clearance

    Feb 20, 2024
    Modular Medical, Inc. has submitted its MODD1 next-generation insulin pump for FDA clearance, aiming to revolutionize the diabetes market with user-friendly and affordable technology. Chairman Paul DiPerna highlights the company's goal of encouraging wider adoption of insulin pumps by simplifying design and reducing costs.
  • New CGM Certificate, New Learning Platform

    Jan 22, 2024
    The latest version of the CGM Certificate Program was built on our new learning platform. Enhancements range from more active engagement through interactive elements to more flexibility and accessibility.
  • Dexcom Unveils Stelo CGM for People Who Do Not Take Insulin

    Jan 12, 2024
    Dexcom unveiled its new Stelo device during the J.P. Morgan Healthcare Conference. The Stelo is based on Dexcom's G7 CGM and is specifically designed for individuals who do not take insulin. This product is part of Dexcom's ongoing efforts to cater to a broader range of patients.
  • Tandem launches t:slim X2 insulin pump software with Dexcom G7 CGM integration

    Dec 7, 2023
    Tandem Diabetes Care, Inc. has announced the release of updated t:slim X2™ insulin pump software featuring integration with Dexcom G7 Continuous Glucose Monitoring (CGM) technology in the United States. The company plans to provide a complimentary remote software update to all in-warranty t:slim X2 users, allowing them to access Dexcom's latest CGM advancements. New t:slim X2 pumps with the integrated software are currently being shipped to customers, while the Dexcom G7 integration is expected to launch in additional countries outside the U.S. in early 2024.
  • Demystifying AI in Diabetes Tech: It's Already Here (and here's why you should cautiously embrace it).

    Nov 16, 2023
    AI is a tool to amplify human expertise, not replace it. Its footprint in diabetes technology is already substantial and growing rapidly. Like everyone, healthcare professionals need to stay informed and even, embrace AI's role in diabetes care for better patient outcomes.
  • Omnipod 5 App for iPhone Receives FDA 510(k) Clearance

    Nov 16, 2023
    Insulet Corporation has received FDA clearance for its Omnipod 5 App for iPhone, becoming the first company to offer a tubeless automated insulin delivery system with complete control via compatible Android and iOS smartphones. It will integrate with the Dexcom G6 Continuous Glucose Monitoring System initially, with a full market release in 2024, and is available at no cost to Omnipod 5 System users.
  • G6 discontinuation & upgrading to Dexcom G7

    Nov 16, 2023
    Dexcom is in the process of discontinuing Dexcom G6. They are working in phases to transition all of their customers to Dexcom G7 and stand-alone Dexcom G6 systems are the first phase.
  • Accu-Chek Solo micropump system received FDA approval

    Nov 16, 2023
    The tubeless Accu-Chek Solo micropump system from Roche has gained FDA approval, providing a new insulin delivery solution for individuals aged 2 years and older with type 1 diabetes.
  • Tandem announces it's technology access program

    Nov 16, 2023
    Tandem Diabetes Care announced a tech access program to give t:slim X2 customers a purchase pathway to the tandem mobi system for $199.
  • ADCES2023 has tech (& puppies, too)!

    Nov 16, 2023
    ADCES 2023 is full of amazing educational sessions, exhibitors, and opportunities for hands-on learning with a tech focus and since I don’t want to bury the lead, this year we also get puppies!
  • Tandem Mobi FDA approved

    Nov 16, 2023
    Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, today announced U.S. Food and Drug Administration (FDA) clearance for the Tandem Mobi insulin pump for people with diabetes age 6 and up, expanding the company’s portfolio of products. The Tandem Mobi is fully controllable from a mobile app and is the world’s smallest durable automated insulin delivery system.
  • 1.3 billion diabetes cases expected by 2050

    Nov 16, 2023
    A recent study published in The Lancet reveals that the global prevalence of diabetes is expected to more than double in the next 30 years, affecting over 1.3 billion people worldwide. Currently, over half a billion people are living with diabetes, with a global prevalence rate of 6.1%. Diabetes is identified as one of the top 10 leading causes of death and disability globally. The study highlights regional variations, with the highest rates found in North Africa and the Middle East. Additionally, the research emphasizes that almost all cases (96%) are type 2 diabetes (T2D), with high body mass index (BMI) being the primary risk factor. The study emphasizes the complex nature of diabetes prevention and control, involving genetic, logistical, social, and financial factors. The findings stress the need for a comprehensive understanding of diabetes impact at a granular level to address disparities and improve access to screening and treatment. The study was supported by the Bill & Melinda Gates Foundation.
  • First, Read the Instructions

    Nov 16, 2023
    One educator’s “lessons learned” on working with new technology and upgrades.
  • FDA Approves iLet Bionic Pancreas

    Nov 16, 2023
    The FDA has cleared the iLet Bionic Pancreas system for patients aged 6 and older with type 1 diabetes. The pocket-sized system includes the Beta Bionics iLet ACE pump and the iLet Dosing Decision Software, along with an integrated continuous glucose monitor (CGM). The FDA's decision was based on the system's Breakthrough Device Designation and aims to provide the type 1 diabetes community with more options for diabetes management. The system is easy to initiate, as it only requires the patient's body weight for insulin dosing and does not need manual adjustments. It features a meal announcement feature that estimates carb consumption, removing the need for traditional carb counting. The system demonstrated its efficacy in a pivotal trial, showing improved HbA1c levels and increased time spent in the target glucose range.
  • AACE Releases 2023 Comprehensive T2 Diabetes Management Algorithm

    Nov 16, 2023
    American Association of Clinical Endocrinology (AACE) has released the 2023 Comprehensive Type 2 Diabetes Management Algorithm to guide healthcare professionals in clinical decision-making for the management of Type 2 diabetes. The updated algorithm emphasizes a person-centered approach to care, incorporating the latest evidence-based recommendations, associated conditions, complications, and health equity. Key elements include lifestyle modification and treatment of overweight and obesity, treatment of cardiovascular risk factors, and immunization recommendations for people with T2D.
  • Insulet Announces FDA Clearance of Omnipod GO™, Basal-Only Insulin Pod

    Nov 16, 2023
    Insulet Corporation has announced the FDA clearance of its latest innovation, Omnipod GO, an insulin delivery device cleared for use for people with type 2 diabetes age 18 or older who would typically take daily injections of long-acting insulin. Omnipod GO is a standalone, wearable, insulin delivery system that provides a fixed rate of continuous rapid-acting insulin for 72 hours. The newest addition to the Omnipod brand features a tubeless and waterproof Pod which is offered in seven different pre-programmed daily rates, ranging from 10 to 40 units per day, and operates without the need for a handheld device to control the Pod. The product was developed as an alternative to daily injections. Insulet plans to commercialize Omnipod GO in the United States in 2024.
  • Lilly to divest BAQSIMI to Amphastar

    Nov 16, 2023
    Eli Lilly and Company (NYSE: LLY) and Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) have entered into a definitive agreement for Lilly to divest BAQSIMI worldwide to Amphastar, a global pharmaceutical company focused on developing, manufacturing, and marketing injectable, intranasal, and inhalation products including experience with a glucagon product. BAQSIMI is the first and only nasally administered glucagon for the treatment of severe hypoglycemia in people with diabetes. Amphastar expects to provide dedicated commercial investment for BAQSIMI with the goal of enabling more people on insulin to be prepared with a glucagon rescue treatment for severe hypoglycemia.
  • FDA Approves Medtronic MiniMed 780G System

    Nov 16, 2023
    Medtronic has received US FDA approval for its MiniMed 780G system with the Guardian 4 sensor, a closed-loop insulin delivery system for people living with type 1 diabetes. The system, which features meal detection technology, provides automatic adjustments and corrections to sugar levels for both basal and bolus insulin needs. It is the only system on the market with a glucose target setting as low as 100 mg/dL, which more closely mirrors the average glucose of someone without diabetes. Users can wear the infusion set for up to seven days, double the wear time of similar systems. The MiniMed 780G system is approved for people aged seven and above with type 1 diabetes.
  • Aspect Biosystems and Novo Nordisk enter partnership to develop bioprinted tissue therapeutics for diabetes and obesity

    Apr 12, 2023
    Aspect Biosystems, and Novo Nordisk are collaborating to develop bioprinted tissue therapeutics for the treatment of diabetes and obesity. Novo Nordisk will have an exclusive worldwide license to use Aspect's bioprinting technology to develop up to four products to treat diabetes and/or obesity. The goal of the collaboration is to develop implantable bioprinted tissues that will replace, repair, or supplement biological functions inside the body to deliver a new class of disease-modifying treatments. The collaboration will initially focus on developing bioprinted tissue therapeutics designed to maintain normal blood glucose levels without the need for immunosuppression, which could represent a transformative treatment for people living with type 1 diabetes.

The Danatech Digest

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DISCLAIMERS:

This site and its services do not constitute the practice of medical advice, diagnosis or treatment. Always talk to your diabetes care and education specialist or health care provider for diagnosis and treatment, including your specific medical needs. If you have or suspect that you have a medical problem or condition, please contact a qualified health care professional immediately. To find a diabetes care and education specialist near you, visit the ADCES finder tool.

ADCES and danatech curate product specifics and periodically review them for accuracy and relevance. As a result, the information may or may not be the most recent. We recommend visiting the manufacturer's website for the latest details if you have any questions.


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