First-Ever Artificial Pancreas Software Receives European Approval
By Adam Brown
Twitter summary: The GlucoSitter artificial pancreas algorithm is approved in the EU. When and how will it actually reach ppl w/ #diabetes?
At the ATTD Conference in Paris, we learned from listening to Dr. Moshe Phillip that the GlucoSitter software received a CE Mark in Europe, making it the first-ever artificial pancreas algorithm to receive regulatory approval in the world. The approval is an important step for the entire artificial pancreas field, and now the question is when and how this software algorithm will reach patients – to date, it has to run on a laptop, meaning it will need to be built into a pump or onto a more convenient handheld device that patients can use. A newly established company, DreaMed Diabetes, is tasked with the commercialization of this algorithm into a full closed-loop system (software algorithm + pump + CGM).
The GlucoSitter software is based on the MD-Logic closed-loop algorithm and is the product of the Diabetes wiREless Artificial Pancreas ConsortiuM (DREAM). The group – composed of diabetes centers in Germany, Israel, and Slovenia – has been testing GlucoSitter in a slew of trials over the past few years. Use of the MD-Logic algorithm has significantly decreased patients’ time spent in hypoglycemia and increased their time spent in-range in overnight and 24-hours/day use. In the team’s study published in the New England Journal of Medicine, diabetes campers on the system had 68% fewer hypoglycemia episodes and spent nearly double the time in the range of 70-140 mg/dl overnight. In studies to date, the GlucoSitter software has run on a laptop that communicates with a Medtronic pump and Medtronic Enlite CGM. It is currently unclear which pump and CGM the DREAM group will use in the future when launching the product.
In the US, DREAM is planning to submit an entire closed-loop system using this algorithm software for FDA approval, though the timing and specifics of this plan are unclear at this point. To stay updated on the latest, please see our resource pages on upcoming artificial pancreas research. –AJW/AB