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Efficacy and safety of hybrid closed-loop systems in children and young people

Hybrid closed-loop systems result in significant improvements in glycaemic control, hypoglycaemia, fear of hypos and sleep scores.

Hybrid closed-loop (HCL) devices provide automated basal insulin delivery with rates calculated from continuously monitored glucose levels, supplemented by manual (user-calculated) mealtime boluses. In this real-world, observational study, children and young people with type 1 diabetes were prospectively recruited into an NHS England trial to determine the efficacy and safety of HCL devices. The devices included the Tandem Control-IQ AP system, the Medtronic MiniMed 780G and the CamAPS FX.

In total, 251 participants were enrolled (mean age 12.3 years; range 2–19 years) with a mean diabetes duration of 6.6 years (range 1.0–15.7 years). After 6 months of treatment, mean HbA1c had fallen significantly from 62 mmol/mol (7.8%) to 55 mmol/mol (7.2%). Mean time in range increased from 49% to 63%.

The proportion of time spent in hypoglycaemia fell from 3.6% to 2.4% (P<0.001), and mean Hypoglycaemia Fear Survey scores decreased by 7.4 points in HCL users and 11.3 points in parents/carers. Sleep scores also improved significantly in both HCL users and parents/carers.

Users with higher HbA1c at baseline were more likely to have greater improvements in glycaemic control than those with lower HbA1c, who saw more marginal improvements. However, the authors point out that even the latter group saw benefits in terms of reduced hypoglycaemia.

The authors conclude that children and young people showed significant improvements in glycaemic control, hypoglycaemia, fear of hypos and sleep scores when using HCL systems for 6 months. There were no differences in any of the outcome measures between the three different types of HCL system used; however, the study was not designed to test superiority or non-inferiority.

Click here to read the study in full.

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