ViCentra Kaleido patch pump hits TIR targets in 3,918-patient study
ViCentra has presented a large-scale real-world analysis of its Kaleido insulin patch pump system at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Milan, reporting strong glycaemic outcomes across an unselected population of 3,918 adults with type 1 diabetes in Germany, the Netherlands and France.
The post-market analysis covered 323,814 person-days of data, representing more than 90% of the active adult user base at the time of extraction. Participants used Kaleido in combination with Diabeloop's DBLG1 automated insulin delivery algorithm and the Dexcom G6 continuous glucose monitor, spending a median of 97% of sensor-wear time in closed-loop mode.
Glycaemic outcomes
Median time in range was 72.2%, meeting the international consensus target of at least 70%. Median time below the 3.9 mmol/L threshold was 1.23%, while median time below the more severe 3.0 mmol/L threshold was 0.21%, equivalent to roughly three minutes per day. Both hypoglycaemia measures fell within international consensus recommendations.
The study's most notable finding was glycaemic stability across age groups. Median coefficient of variation was 28.7%, comfortably below both the 36% international stability threshold and the 33% level associated in published literature with reduced hypoglycaemia risk. Crucially, variability remained below those thresholds in every adult cohort, ranging from 26.8% in users aged 65 and over to 31.1% in the 18-to-24 age group.
Fred Storms, endocrinologist and first author, said the combination of outcomes was particularly encouraging: "Across a large and unselected population, users achieved recommended time in range with very little hypoglycaemia and consistently low glycaemic variability."
All five study authors have disclosed relationships with ViCentra or Diabeloop, the algorithmic partner, and the analysis was funded by both companies. Readers should weight the results accordingly, while noting that the absence of eligibility criteria beyond active system use is a meaningful design choice that reduces selection bias compared with many company-sponsored datasets.
Market context
The automated insulin delivery market is expanding rapidly across Europe and North America, driven by uptake of hybrid closed-loop systems and tightening clinical guidance around time-in-range metrics. Established competitors include Insulet's Omnipod 5, Medtronic's MiniMed 780G and Tandem Diabetes Care's t:slim X2, all of which have published substantial real-world and randomised trial datasets. A key differentiator ViCentra is pursuing is device form factor: Kaleido uses a patented valved micro-dosing mechanism rather than a syringe-driven delivery system, and the company positions the product explicitly as a lifestyle device.
ViCentra closed a $98 million Series D earlier this year and has since launched a next-generation system integrating Diabeloop's smartphone-controlled DBLG2 algorithm with Dexcom G7. The data presented at EASD relate to the prior DBLG1 and Dexcom G6 configuration, which the company says provides a validated baseline. The EASD dataset does not yet include outcomes under the current-generation system, meaning investors and clinicians will be watching for DBLG2 real-world evidence as a near-term milestone.
US market entry remains a stated ambition. Navigating FDA clearance for an automated insulin delivery system typically requires submission under the De Novo or 510(k) pathway and, for full closed-loop claims, a separate algorithm-specific software review. The timeline for that process has not been disclosed.