Diabeloop receives FDA 510(k) clearance for DBLG2, an Automated Insulin Delivery algorithm in an App

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Diabeloop receives FDA 510(k) clearance for DBLG2, an Automated Insulin Delivery algorithm in an App: a strategic turning point. The company confirms its status as a global reference partner for automated insulin delivery, with the validation of its DBLG2 algorithm and its predetermined Change Control Plan (PCCP) by the FDA.
GRENOBLE, France - January 8th, 2026 - Diabeloop announces today that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for DBLG2, as a Class II "Interoperable Automated Glycemic Controller" (iAGC), officially opening the doors of the U.S. market for the company. The clearance was granted on December 18, 2025.

A key partner for pump manufacturers, more choice for Patients with Diabetes

This approval goes beyond a simple regulatory framework; by obtaining clearance on this interoperability status, it positions Diabeloop as a central player in the global diabetes ecosystem, and opens the door to multiple launches in the US in 2026 and 2027.

Francois Miceli, CEO of Diabeloop, highlights the strategic importance of this announcement:

"This is a crucial milestone for the company. This clearance positions us as the reference and independent AID (Automated Insulin Delivery) partner for any pump manufacturer wishing to establish themselves simultaneously in the United States and Europe. We now offer an algorithmic platform validated in the two largest AID markets in the world, with an ongoing development in Japan.

" The latest data from IDF refers to 2.7 million people with T1D in Europe and between 1.4 and 1.8 million in the USA. While AID users are increasing year after year in the countries with adapted reimbursement, this is not yet adopted by the majority of patients. We are proud to enable more patients to have access to it and provide them with a choice of the technology combination they prefer.

" More than 12,000 patients have been able to benefit from DBLG1, our first device launched in 2021. DBLG2, which is an App (Android and iOS), is built on this solid clinical foundation and brings additional features to simplify patients' lives. This is one major step in our journey, with more to come in the coming months. This agreement will accelerate our commercial roadmap considerably. "

Erik Huneker, co-founder and Director of QA, RA & CA, reflects on the journey and the company's mission:

"Behind this clearance are years of research and data collection with a willingness to continuously improve our outcomes and with one clear mission: helping those with Type 1 diabetes focus less on their disease and more on their lives. DBLG2 is built to adapt to real life: flexible meal announcements, sports, sleep, and rest.

" Making decisions easier, not harder. This step forward paves the way for us to bring DBLG2 to more people, both in the US and globally. The FDA has also Approved Diabeloop Predetermined Change Control Plan (PCCP). This mechanism allows the company to evolve its device according to a pre-established protocol for integrating new pumps or CGMs that conform to FDA requirements, without having to re-submit a 510(k) filing."

About DBLG2:

Simplicity at initialization, personalization, improved outcomes and one step closer to Full Closed Loop. DBLG2 is a next-generation algorithm, within an App (Android and iOS), designed to automate and personalize insulin delivery for patients with Type 1 Diabetes. By analyzing glucose data in real-time, it adjusts insulin delivery to maintain blood sugar levels within an optimal target range, thereby reducing the mental burden associated with the daily management of Type 1 diabetes.

The objective of DBLG2 is to be as simple as possible while allowing a personalization of the algorithm necessary to respond to the diversity of existing T1D physiologies, specific medical conditions or just personal preferences. You just need to enter your weight and total daily dose of insulin to get it started. DBLG2 has a self-learning module that applies improvements to the patient's algorithm parameters, based on estimated glycemia history and insulin delivery quantities, from the patient's history.

Since the first market launch, relentless efforts have been made in continuously improving the algorithm resulting in a gain of more than 3 points of Time in Range as published in December 2025. (Ref: J Diabetes Sci Technol. https://pubmed.ncbi.nlm.nih.gov/41414695)

DBLG2 is one step closer to full close loop: If you choose not to declare meals, DBLG2 will continue to manage your glucose automatically, but glucose control may be less optimal than when you declare your meals. Presented at EASD 2022, results on over 4,000 users reported that trust in the DBLG algorithm led to fewer meal declarations and users sometimes skipped or used Approximate carbohydrate entries.

Its interoperable status allows it to connect with various compatible insulin pumps and sensors (ACE pumps and iCGM). DBLG2 is an App for smartphones, available initially on Android and soon on iOS. A promising pipeline: From indication extension to full close loop and GLP-1 management. In the short term we are targeting indication extension for Kids age 4+, pregnancy and type 2 diabetes, either through the numerous clinical data we have already generated or clinical studies we are about to initiate.

A full closed loop system is clearly a priority on our roadmap since our inception, building up on the advanced simplified meal management we developed and our ability to tune our algorithm to reflect physiological conditions from new sensor signals.

GLP-1 management functionalities have been developed and will be included in a forthcoming clinical trial to address the challenges faced by insulin users when adopting GLP-1 therapy.The above potential indications are currently under investigation and have not been cleared by the FDA for use in the United States.

About Diabeloop

Founded in 2015, Diabeloop offers artificial intelligence-based solutions to people living with diabetes to automate and personalize their treatment management. By connecting a continuous glucose monitor (CGM) and an insulin pump via unique self-learning algorithms, Diabeloop allows patients to delegate many therapeutic decisions and live their lives without interruption.

DBLG1, the first marketed device in Europe from Diabeloop is interoperable with the following pumps: Kaleido (ViCentra), Dana-i (Sooil), MEDISaFE WITH (Terumo) and Accu-Chek Insight (Roche).

DBLG1 is connected with Dexcom G6 CGM. DBLG2 received its CE mark under MDR in August 2025 and is currently in its pre-launch phase, paired with the Dexcom G6 and ViCentra's Kaleido. The full launch is scheduled for early 2026, featuring Dexcom G7 integration and compatibility with both Kaleido and Dana-i insulin pumps.

Press Contact:

contact@diabeloop.fr
Media Contact
Company Name: Diabeloop
Contact Person: Media Relations
Email: Send Email [http://www.universalpressrelease.com/?pr=diabeloop-receives-fda-510k-clearance-for-dblg2-an-automated-insulin-delivery-algorithm-in-an-app]
Country: France
Website: http://diabeloop.fr

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This release was published on openPR.