Diabeloop, a pioneer in therapeutic artificial intelligence for diabetes management, today announces that DBLG2 Automated Insulin Delivery (AID) system, fully integrated with ViCentra’s Kaleido insulin patch pump and Dexcom G7 Continuous Glucose Monitoring (CGM), is now officially open for prescription in Germany (and the Netherlands later this summer).
Following its CE marking approval, this highly anticipated commercial rollout marks a major milestone in Diabeloop’s strategic transition toward a pure software, patient-centric experience. By hosting the self-learning DBLG2 algorithm directly on the user’s personal Android smartphone (with iOS coming soon), the system eliminates the need for a dedicated handset, offering discretion, convenience, and a reduced environmental footprint.
Proven Real-World Outcomes for Peace of Mind
Built upon a deeply trusted algorithmic core already used by more than 10,000 users across Europe, the system delivers outstanding clinical outcomes. Real-world data of Kaleido users with DBLG2 demonstrates a remarkable Time in Range (TIR) of >77% and an exceptionally low Time Below Range (TBR) of just 0.2%¹, showcasing the algorithm’s ability to maximize safety and glycemic control with minimal user effort².
Advanced Adaptability to Everyday Life
The self-learning DBLG2 algorithm automatically analyzes glucose data and adjusts insulin delivery every 5 minutes to fit the user’s life. Designed to alleviate the daily mental burden of diabetes management, the system features a highly flexible and comprehensive suite of tools:
- Advanced Activity Management: Users can choose from 29 predefined activity profiles to proactively adjust insulin delivery and reduce exercise-related hypoglycemia risks.
- Tailored Meal Options: Alongside automated corrections and flexible meal announcements, the app includes a dedicated “Fat Meal” mode to optimize postprandial glucose control for complex carbohydrate intakes.
- Uninterrupted Sleep: A customizable Night Mode automatically reduces and extends specific alerts at night, ensuring users and caregivers can rest without unnecessary disturbances.
A Perfectly Integrated Hardware Ecosystem
This commercial launch brings together best-in-class hardware technologies controlled seamlessly from the patient’s phone:
- The Kaleido Insulin Patch Pump: Kaleido, the smallest, lightest, and most precise insulin patch pump in its class, is designed to offer greater flexibility and personal choice. Available in a range of colour combinations, it can be worn discreetly on the body or carried comfortably in a pocket. Kaleido is waterproof for everyday activities3, including swimming, and can also be temporarily disconnected when needed.
- Dexcom G7 CGM: Dexcom G7 offers a better way to help users gain greater control of their diabetes, so that they can manage it more confidently each day. Its low-profile, all-in-one wearable warms up faster than any other CGM on the market, sending real-time glucose readings automatically to a compatible smart device or receiver, no fingerpricks or scanning required. Dexcom G7 also offers a suite of customizable alerts that can warn of high or low glucose levels and send predictive alerts to help users spend more time in range. Industry-leading remote monitoring and reporting capabilities also allow users to stay connected with their loved ones and care teams anytime, anywhere.
Launch Timeline, Prescription Details and More
Prescriptions for new users are being processed immediately through distributor networks (such as Mediq and Spezimed) in Germany (and the Netherlands later this summer). For current users of DBLG1, the transition to the new system will occur progressively over the coming months, managed in close coordination with their healthcare teams and based on current sensor availability.
For comprehensive specifications, clinical details, and to explore the system interface, please visit the official DBLG2 overview page at dbl-diabetes.com/dblg2-system.
Try the DBLG2 algorithm
Discover the interface today! DBLG2 Demo App is now available on the Google Play Store in Germany and the Netherlands. This interactive simulation allows patients and healthcare teams to virtually experience device pairing and explore the app’s features firsthand.
(DBLG2 Demo app is not a medical device and must not be used for therapeutic decisions).
Founded in 2015, Diabeloop develops AI-based solutions to help people living with diabetes automate and personalize their treatment. By connecting CGMs and insulin pumps through proprietary self-learning algorithms, Diabeloop enables users to delegate therapeutic decisions and live with fewer daily interruptions.
(1) Real-world data of Kaleido users. Data on file.
(2) Meal announcements are no longer mandatory, though announcing meals may support better glycemic outcomes.
(3) In 1.5m of water for up to 1 hour.