For patients with type 1 diabetes mellitus (T1DM), maintaining glycaemic control can be challenging. Artificial pancreata, which are closed-loop insulin delivery systems, monitor and detect changes in blood concentrations of glucose and deliver insulin when needed. Now, in the largest randomized study of closed-loop delivery systems so far, an artificial pancreas has shown wide-ranging benefits, including reduced mean glucose levels and reduced time spent in hypoglycaemia, in a cohort of individuals with sub-optimally controlled T1DM.

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“Our [overarching] aim is to make the closed-loop technology widely available and the present study was designed to provide information to support [closed-loop insulin delivery systems] for individuals with sub-optimally [controlled] T1DM,” explains corresponding author Roman Hovorka. “We applied the standard randomized controlled trial design, included sites in two countries (UK and US) and enrolled children, adolescents and adults to increase the generalizability of the findings.”

…the closed-loop system resulted in a reduction in HbA1c … and a reduction in glucose variability

Hovorka and colleagues randomly assigned 86 individuals aged 6 years and older to receive hybrid closed-loop therapy (n = 46) or sensor-augmented pump therapy (n = 40; control group) and followed them up for 12 weeks. The primary end point was the difference between the control group and treatment group in the amount of time participants spent in the target glucose range of 3.9–10.0 mmol/l (70–180 mg/dl), which was based on sensor-measured glucose concentrations during the 12-week free-living phase.

The authors report that the closed-loop system resulted in reductions in HbA1c, mean glucose levels, time spent in hypoglycaemia and glucose variability. These benefits were observed irrespective of age.

“Several studies are ongoing or are planned, including testing a closed-loop insulin delivery system in newly diagnosed adolescents with T1DM, as well as young children aged 1–7 years and older adults aged >60 years with T1DM,” concludes Hovorka. “Our ultimate aim is to commercialize our closed-loop algorithm and make it widely available.”