DBLG2 received authorization as a Class II interoperable automated glycemic controller (i-AGC). Clearance validates the algorithm’s interoperability and could bring more choice to people with diabetes, the company said on LinkedIn. It marks the latest milestone for the company’s next-generation algorithm, which follows DBLG1. Diabloop received CE mark approval for DBLG2 in August.
By securing i-AGC status, as well as approval for a Predetermined Change Control Plan (PCCP), the company says it can set “a new standard for agility and safety in automated diabetes management.”
Diabeloop said the clearance positions it as a possible automated insulin delivery partner for any manufacturer in the U.S. and Europe. The company previously partnered on insulin delivery with companies such as SOOIL, EOFlow and, most recently, ViCentra. In the near future, ViCentra plans to roll out its next-generation Kaleido pump with DBLG2.
Currently, Diabeloop said the algorithm is in the pre-launch phase, paired with Kaleido and the Dexcom G6 sensor. It expects a full launch in early 2026, followed by Dexcom G7 integration. The company also plans for future integration with the Dana-i pump from SOOIL.
FDA clearance covers DBLG2 for the management of type 1 diabetes in people aged 12 and older.
“Most importantly, this is a victory for the diabetes community,” Diabeloop wrote on LinkedIn. “We are one step closer to offering a new, powerful option to help patients live their lives without interruption.
