Charles Sternberg, Associate Editor11.21.23
ViCentra B.V., the company behind Kaleido, one of the world’s smallest, lightest insulin patch pump systems for managing type 1 diabetes, has launched a Hybrid Closed Loop system for automated insulin delivery. This system delivers insulin by using the DBLG1 algorithm, which receives input from the Dexcom G6 Continuous Glucose Monitoring (CGM) sensor.
It combines the convenience of the Kaleido insulin pump with two market-leading innovations designed by Diabeloop and Dexcom to create a Hybrid Closed Loop system for managing type 1 diabetes which is flexible, self-learning and easy to use.
Frans Cromme, Chief Executive Officer of ViCentra, said: “We aim to deliver the best user experience as well as excellent clinical results with our Kaleido insulin pump and our partners. Kaleido with DBLG1 and Dexcom G6 improves users’ Time in Range by 16.7%1, an achievement that should bring real benefits to people with type 1 diabetes. We are proud to deliver this game changing technology via a beautiful and small device, as we feel people deserve this when they need to rely on a medical device 24/7.”
Kaleido users can wear their pump as a patch or place it in their pocket at their own discretion. The system comes with two durable pumps that are rechargeable, eliminating the need to dispose of the pump every 3 days as other patch pumps do. It is available in 10 bright colors and provides the ability to pause or take the pump off for intermittent breaks.
Diabeloop’s DBLG1 is a system deploying a well-known algorithm that is used by 10,000+ users2 in Europe already. The system draws on real-time glucose data, reducing hypoglycaemia by more than 50%3 and using personalized parameters and self-learning to adjust Kaleido’s insulin delivery for an optimized management of type 1 diabetes. DBLG1 algorithm considers the user’s glucose levels provided by the Dexcom G6 Continuous Glucose Monitor (CGM) alongside inputs on meals and activities to determine the insulin delivery. Users and healthcare professionals have real-time access to their data insights via automated transfer to the cloud platform YourLoops.
ViCentra is launching the Hybrid Closed Loop system in Germany, the Netherlands and France with its commercial partner Diabeloop. Roll-out to additional countries which include the UK and Italy is planned for 2024.
References:
1 Amadou, Coralie, Sylvia Franc, Pierre-Yves Benhamou, Sandrine Lablanche, Erik Huneker, Guillaume Charpentier, and Alfred Penfornis. 2021. “Diabeloop DBLG1 Closed-Loop System Enables Patients With Type 1 Diabetes to Significantly Improve Their Glycemic Control in Real-Life Situations Without Serious Adverse Events: 6-Month Follow-Up.” Diabetes Care 44(3):844–46. doi: 10.2337/dc20-1809.
2 English Portal - Diabeloop: interoperable self-learning diabetes management solutions (cea.fr)
3 Benhamou, Pierre-Yves, Alice Adenis, Yousra Tourki, Sylvie Pou, Stéphanie Madrolle, Sylvia Franc, Dulanjalee Kariyawasam, Jacques Beltrand, David C. Klonoff, and Guillaume Charpentier. 2022. “Efficacy of a Hybrid Closed-Loop Solution in Patients With Excessive Time in Hypoglycaemia: A Post Hoc Analysis of Trials With DBLG1 System.” Journal of Diabetes Science and Technology 193229682211285. doi: 10.1177/19322968221128565.
It combines the convenience of the Kaleido insulin pump with two market-leading innovations designed by Diabeloop and Dexcom to create a Hybrid Closed Loop system for managing type 1 diabetes which is flexible, self-learning and easy to use.
Frans Cromme, Chief Executive Officer of ViCentra, said: “We aim to deliver the best user experience as well as excellent clinical results with our Kaleido insulin pump and our partners. Kaleido with DBLG1 and Dexcom G6 improves users’ Time in Range by 16.7%1, an achievement that should bring real benefits to people with type 1 diabetes. We are proud to deliver this game changing technology via a beautiful and small device, as we feel people deserve this when they need to rely on a medical device 24/7.”
Kaleido users can wear their pump as a patch or place it in their pocket at their own discretion. The system comes with two durable pumps that are rechargeable, eliminating the need to dispose of the pump every 3 days as other patch pumps do. It is available in 10 bright colors and provides the ability to pause or take the pump off for intermittent breaks.
Diabeloop’s DBLG1 is a system deploying a well-known algorithm that is used by 10,000+ users2 in Europe already. The system draws on real-time glucose data, reducing hypoglycaemia by more than 50%3 and using personalized parameters and self-learning to adjust Kaleido’s insulin delivery for an optimized management of type 1 diabetes. DBLG1 algorithm considers the user’s glucose levels provided by the Dexcom G6 Continuous Glucose Monitor (CGM) alongside inputs on meals and activities to determine the insulin delivery. Users and healthcare professionals have real-time access to their data insights via automated transfer to the cloud platform YourLoops.
ViCentra is launching the Hybrid Closed Loop system in Germany, the Netherlands and France with its commercial partner Diabeloop. Roll-out to additional countries which include the UK and Italy is planned for 2024.
References:
1 Amadou, Coralie, Sylvia Franc, Pierre-Yves Benhamou, Sandrine Lablanche, Erik Huneker, Guillaume Charpentier, and Alfred Penfornis. 2021. “Diabeloop DBLG1 Closed-Loop System Enables Patients With Type 1 Diabetes to Significantly Improve Their Glycemic Control in Real-Life Situations Without Serious Adverse Events: 6-Month Follow-Up.” Diabetes Care 44(3):844–46. doi: 10.2337/dc20-1809.
2 English Portal - Diabeloop: interoperable self-learning diabetes management solutions (cea.fr)
3 Benhamou, Pierre-Yves, Alice Adenis, Yousra Tourki, Sylvie Pou, Stéphanie Madrolle, Sylvia Franc, Dulanjalee Kariyawasam, Jacques Beltrand, David C. Klonoff, and Guillaume Charpentier. 2022. “Efficacy of a Hybrid Closed-Loop Solution in Patients With Excessive Time in Hypoglycaemia: A Post Hoc Analysis of Trials With DBLG1 System.” Journal of Diabetes Science and Technology 193229682211285. doi: 10.1177/19322968221128565.