A second closed-loop insulin pump will soon be available for sale in European countries.
On April 9th, Diabeloop, a French medical device manufacturer, announced it has entered into a distribution deal to facilitate the sale of its DBLG1 closed-loop insulin pump system in select countries in Europe. The pump system was granted the CE Mark from European health regulators in December 2018, and has been available for sale in the Netherlands.
It will join the Medtronic 670G as one of just two closed-loop insulin pump systems capable of using artificial intelligence technology to automatically adjust basal rates based on readings from a continuous glucose monitor (CGM).
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Unlike the 670G, Diabeloop’s DBLG1 system is the first closed-loop system on the market that is made up of components from separate diabetes device companies. The pump system includes a Kaleido patch pump, a Dexcom CGM, and an Android controller. Diabeloop also has been working to make its blood glucose management algorithms compatible with Cellnovo insulin pumps.
Currently, the DBLG1 system is only available for use in Europe for adults with type 1 diabetes, but Diabeloop is putting out signals that this could soon change. During an appearance at CES 2019, a popular technology trade show in Las Vegas, Diabeloop officials touted the pump system’s potential for children with type 1 diabetes. According to a Healio report, the company is planning pivotal trials of an adapted DBLG1 system for pediatric patients in Belgium and France later this year.
So far, the company has not submitted the DBLG1 system to the FDA for approval. Since the company gained the CE mark for the pump system, however, the FDA has created a regulatory pathway for such a system to gain access to U.S. markets. U.S. health regulators have already granted approval for an iCGM and an ipump; both devices are designed to work interoperably with devices and algorithms from multiple diabetes tech companies to create closed-loop insulin pump systems.
Currently, there is no automated insulin delivery (AID) algorithm approved by the FDA under the new interoperable regulatory pathway.