Hybrid closed-loop systems are increasingly gaining recognition as a gold-standard option for diabetes management, and medtech makers are jumping at the opportunity to add their own artificial pancreases to the mix.
Among the latest additions is one that combines tech from ViCentra, Diabeloop and Dexcom to help people with Type 1 diabetes better manage the condition, and which is now set to begin rolling out in Europe, ViCentra announced Tuesday.
Hybrid closed-loop systems rely on an algorithm to first analyze real-time blood sugar readings from a continuous glucose monitor, then use the results to adjust an insulin pump’s output as needed throughout the day. In this case, the algorithm was developed by Diabeloop, the CGM is a Dexcom G6 sensor, and the insulin pump comes from ViCentra.
The artificial pancreas system will begin its European launch this year in France and the Netherlands—the home countries of Diabeloop and ViCentra, respectively—and in Germany, before expanding further across the continent in 2024, to countries including the U.K. and Italy. ViCentra and Diabeloop will team up on the rollout through the European distribution partnership they formed in 2019.
ViCentra, Diabeloop and Dexcom have been studying the effects of their combined technologies for several years.
One study published in the journal Diabetes Care in 2021 followed 25 people with Type 1 diabetes who were tasked with using the artificial pancreas system for six months—all but one of whom did so for the entire study period.
After using the technology for six months, the two dozen patients saw their average HbA1c levels drop from a baseline of 7.9% to 7.1%. The amount of time they spent per day in a healthy glucose range, meanwhile, improved from an average of 53% at the start of the study to just under 70% by its end.
None of the participants experienced any serious adverse events while using the system during the study.
All three devices have had CE mark clearance in Europe since 2018.
ViCentra’s Kaleido insulin pumps are designed to be customized to each user’s tastes: Not only do they come in 10 color options, but they can also be either worn as a patch pump—when connected to a shorter infusion tubing set—or carried in a user’s pocket, with longer tubing connecting to the body.
The Kaleido system comes with two rechargeable pumps so that one is always available while the other is charging, while also eliminating the waste associated with single-use pumps. A full charge can last up to three days.
Users can monitor and alter the Kaleido device’s insulin dosages themselves, and the closed-loop system also allows Diabeloop’s algorithm to automatically make round-the-clock adjustments. The DBLG1 artificial intelligence-powered software is installed on a dedicated handset, which uses Bluetooth to pick up glucose readings from the Dexcom G6 sensor and use those, along with the user’s biological data and recent meals and exercise to tweak insulin dosing if necessary.