- Analysis of 3,918 adults across Germany, the Netherlands and France, with no eligibility criteria beyond active system use, covering 323,814 person-days of real-world experience
- Users achieved median time in range of 72.2%, while median time below 54 mg/dL (3.0 mmol/L) was 0.21% – equivalent to approximately three minutes per day
- Median coefficient of variation of 28.7%, well below the 36% stability threshold and consistent across every adult age group
UTRECHT, The Netherlands, Oct. 01, 2026 (GLOBE NEWSWIRE) — ViCentra, a European medical device company commercializing the Kaleido insulin patch pump system, today announced new real-world data showing strong glycemic outcomes in 3,918 adults with type 1 diabetes using the Kaleido insulin patch pump with Diabeloop’s DBLG1 automated insulin delivery algorithm and the Dexcom G6 continuous glucose monitoring system.
Results presented at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Milan show that Kaleido users met international consensus targets for time-in-range while experiencing very low glycemic variability and minimal hypoglycemia.
The analysis included adults actively using Kaleido with DBLG1 across Germany, the Netherlands and France, representing more than 90% of the active adult user base at the time of data extraction. No eligibility criteria were applied beyond active system use. Participants contributed 323,814 person-days of real-world experience, drawn from up to 90 days of use each.
Median time in range was 72.2%, meeting the international consensus target of at least 70%. Median time below 70 mg/dL (3.9 mmol/L) was 1.23%, and median time below 54 mg/dL (3.0 mmol/L) was just 0.21%, equivalent to approximately three minutes per day. Both measures of hypoglycemia were well within international consensus recommendations.
The most notable finding was the consistency of glucose control. Median glycemic variability, measured by coefficient of variation, was 28.7%. This figure is well below the 36% international stability threshold and below the 33% level linked in published literature to lower hypoglycemia risk. Variability remained below both thresholds in every adult age group, from 26.8% in users aged 65 and over to 31.1% in users aged 18 to 24. In practical terms, users were not simply achieving recommended time in range; they were doing so with remarkably stable glucose levels and very little hypoglycemia.
“These results provide an important view of how Kaleido performs outside the controlled setting of a clinical trial. Across a large and unselected population, users achieved recommended time in range with very little hypoglycemia and consistently low glycemic variability. That combination of strong glucose control and stability is particularly encouraging,” said Fred Storms, MD, PhD, Endocrinologist and first author of the analysis.
“Large-scale real-world evidence provides an important view of how diabetes technologies perform outside controlled clinical trials. What stands out in this analysis is the combination of time in range, very low hypoglycemia and consistently low glycemic variability across a broad population. Looking at variability alongside traditional measures such as time in range provides a more complete picture of glucose control,” said Prof. Dr. Lutz Heinemann, International diabetes technology specialist.
The findings build on previous clinical evidence for Kaleido and its DBLG1 combination and show that these outcomes translate into routine use across a broad real-world population. System engagement was high, with median sensor wear of 98% and users spending 97% of that time in closed-loop mode.
Kaleido delivers advanced automated insulin therapy through a fundamentally different approach to insulin delivery. At its heart is a patented valved micro-dosing system that uses two one-way valves rather than the syringe-driven mechanism used in most insulin pumps. The system is designed to deliver the small, frequent doses used in automated therapy with high precision and consistency.
This approach reflects a core principle behind Kaleido’s design: effective automated insulin delivery requires making the right dosing decision and then delivering the intended dose accurately and consistently.
“These results across nearly 4,000 people are compelling because they show strong time in range, very little hypoglycemia and remarkably stable glucose control in everyday life. They reinforce our belief that intelligent automation, combined with highly precise and consistent insulin delivery at the smallest doses, can make an important difference,” said Tom Arnold, Chief Executive Officer of ViCentra. “Our goal has always been to combine that clinical performance with a pump that is small, discreet, flexible and designed around how people actually want to live,” Arnold continued. “People with diabetes shouldn’t have to choose between strong clinical performance and the experience of wearing their device.”
Kaleido is the smallest, lightest, and most precise insulin patch pump in its class, uniquely designed as a lifestyle product that is discreet, intuitive, and personalized. Designed to feel more like personal technology than a traditional medical device, Kaleido is made with premium materials and features customizable aluminum shells in ten color options, enabling self-expression, not just glycemic control.
The system evaluated in the EASD analysis combines Kaleido with Diabeloop’s DBLG1 algorithm and Dexcom G6. Kaleido’s current-generation system builds on the same insulin delivery platform, now integrating Diabeloop’s smartphone-controlled DBLG2 algorithm with Dexcom G7 to deliver a simpler, more connected experience for people living with diabetes.
The findings come during a year of significant progress for ViCentra, including a $98 million Series D financing, the commercial launch of the smartphone-controlled Kaleido system with DBLG2 and Dexcom G7, and the expansion of manufacturing capacity to support continued growth. Together, these advances position ViCentra to bring Kaleido to significantly more people across Europe while continuing preparations for US market entry.
Abstract and Presentation Details
Session: LBA Short Oral Event F
Title: Glycaemic variability and real-world glycaemic control with the Kaleido insulin patch pump and DBLG1 automated insulin delivery algorithm: a post-market analysis of 3918 adults with type 1 diabetes
Presented by: Dr. A. A. Puiu
Authors: G. Storms, R. McDonagh, A. Vesin, B. Chatel, A. A. Puiu
Date and time: Thursday, October 1, 2026, 14:00 to 15:00 CEST
Funding: Funded by ViCentra B.V. and Diabeloop SA
Disclosures: G. Storms, Medical Advisor, ViCentra B.V.; A. A. Puiu and R. McDonagh, employees of ViCentra B.V.; A. Vesin and B. Chatel, employees of Diabeloop SA. Full disclosures per EASD requirements
For more information, please contact:
Optimum Strategic Communications
Zoe Bolt, Katie Flint, Nellie Stephens
+44 (0) 203 882 9621
Email: vicentra@optimumcomms.com
About ViCentra
ViCentra is on a mission to improve life with diabetes through empathetic innovation, simplicity, and design excellence. The company develops and manufactures the Kaleido insulin patch pump system, a flexible, discreet, and beautifully crafted alternative to traditional insulin pumps. Headquartered in Utrecht, the Netherlands, ViCentra is expanding across Europe and preparing for U.S. market entry. Its investors include Innovation Industries, Partners in Equity, Invest-NL, EQT Life Sciences, ROM Utrecht Region, Venturing Tech, Health Innovations and INKEF. More information about ViCentra can be found at www.hellokaleido.com
About Kaleido
Kaleido is redefining the category of wearable insulin delivery as the first insulin patch pump designed with the form, function, and simplicity of a lifestyle product. Compact, featherlight, and discreet, Kaleido is designed with a focus on personal technology rather than a traditional medical device. It is made from premium materials and features customizable aluminum shells in ten color options, enabling self-expression, not just glycemic control. It offers users flexibility in how and where they wear their pump, allowing people with diabetes to manage their therapy in a way that fits seamlessly into their daily lives.
It is the smallest, lightest, most precise insulin patch pump in its class, delivering advanced, automated insulin therapy through seamless integration with Diabeloop’s clinically validated hybrid closed loop algorithms, DBLG1 and DBLG2.
About EASD
The European Association for the Study of Diabetes e.V. (EASD) is a membership-based academic non-profit organization founded in 1965 and based in Düsseldorf, Germany. It aims are to encourage and support research in diabetes, facilitate the dissemination of scientific knowledge and promote its application in clinical practice.
