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Diabeloop Receives CE Mark for Closed-Loop Insulin Pump System

By Craig Idlebrook/GluCraig

12/03/2018 – This article has been updated to include the model of Dexcom CGM that is compatible with this insulin pump system. 

A second closed-loop insulin pump has made it to market, just not to the U.S market.

French device manufacturer Diabeloop announced in November that its DBLG1 closed-loop semi-automated insulin pump system has received the European Union’s CE mark. This is the second closed-loop insulin pump to make it to market; Medtronic received FDA approval for the first, the 670G, in 2016.

Here are five things to know about this new insulin pump system:

-It consists of a Kaleido insulin patch insulin pump, Dexcom G6 continuous glucose monitor (CGM), and a locked-down cell phone for user control.

-Diabeloop’s algorithm for the pump system incorporates AI technology designed to learn about the individual user’s physiology and then use that information to adjust insulin delivery rates.

-The pump system will automatically adjust basal insulin settings based on CGM readings, but users will need to change their pump settings to account for carbs consumed at meals, much like with the 670G.

-The Kaleido patch is a hybrid patch pump that attaches to the skin, but also includes a short tube that leads to an infusion set.

-This is the first generation of the DBLG1 pump system, and changes are expected in the future. The Kaleido patch pump likely will be swapped out, as Diabeloop and Cellnovo have long been collaborating on a patch pump that works with the pump system.

The CE mark is the regulatory equivalent to FDA approval – it allows drug and device makers to market their products in all European Union member nations. There is no reciprocal agreement with the United States between CE mark approval and FDA approval, but device manufacturers often will seek EU approval before seeking FDA approval. In a Healthline interview, Diabeloop CEO Erik Huneker said the company will slowly roll out the DBLG1 pump system in 2019, but he did not give a definitive timeline for seeking FDA approval.  

To read the press release about the DBLG1 receiving CE mark approval, click here.

To read the informative Healthline interview with Diabeloop CEO Erik Huneker, click here.

To read the results of a study presented this year at the American Diabetes Association’s 78th annual Scientific Sessions of how the DBLG1 performed versus a non-closed insulin pump system in managing blood glucose levels, click here.

 

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