A new insulin patch pump system could reduce hypoglycaemia
Research finds people with type 1 diabetes using system report improved blood glucose control.
A recent study has shown promising results for a new insulin patch pump system that keeps blood glucose levels remain at a stable level.
The manufacturers of a new insulin patch pump system have announced results of recent studies showing strong glycaemic outcomes in 3,918 adults with type 1 diabetes.
European medical device company ViCentra studied 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 recently presented at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Milan showed that Kaleido users met international consensus targets for time-in-range while experiencing very low glycaemic variability and minimal hypoglycaemia (low blood glucose results).
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 the study. No eligibility criteria were applied beyond active system use.
Participants contributed a combined 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 hypoglycaemia were well within international consensus recommendations.
Researchers said the most notable finding was the consistency of glucose control. Median glycaemic 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 hypoglycaemia risk.
In practical terms, researchers said users were not simply achieving recommended time in range; they were doing so with remarkably stable glucose levels and very little hypoglycaemia.
Fred Storms, MD, PhD, Endocrinologist and lead study author said: “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 hypoglycaemia and consistently low glycaemic variability. That combination of strong glucose control and stability is particularly encouraging,”
Professor Dr Lutz Heinemann, International diabetes technology specialist, said: “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 hypoglycaemia and consistently low glycaemic variability across a broad population. Looking at variability alongside traditional measures such as time in range provides a more complete picture of glucose control.”
Tom Arnold, Chief Executive Officer of ViCentra, said: “These results across nearly 4,000 people are compelling because they show strong time in range, very little hypoglycaemia 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.
“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.
“People with diabetes should not have to choose between strong clinical performance and the experience of wearing their device.”
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