Real-world prospective observational single-centre study: Hybrid closed loop improves HbA1c, time-in-range and quality of life for children, young people and their carers

Hybrid closed-loop (HCL) systems are characterised by integrating continuous glucose monitoring (CGM) with insulin pumps which automate insulin delivery via specific algorithms and user-initiated insulin delivery. The aim of the study was to evaluate the effectiveness of HCLs on Hba1c, time-in-range (TIR), time in hypoglycaemia, fear of hypoglycaemia, sleep and quality of life measure in children and young people (CYP) with T1D and their carers. Data on HbA1c, TIR and hypoglycaemia frequency were reviewed at baseline prior to starting HCL and 3 months after commencement. As part of clinical care, all patients and carers were provided with key education on the use of the HCL system by trained diabetes healthcare professionals. CYP aged 12 years and above independently completed the validated Hypoglycaemia Fear Survey (HFS). Parents of patients <12 were asked to complete a modified version of the HFS-Parent (HFS-P) survey. There were 39 CYP (22 men) with T1D included with a mean age of 11.8 ± 4.4 at commencement of HCL. Median duration of diabetes was 3.8 years (interquartile range 1.3-6.0). There were 55% of patients who were prepubertal at the time of HCL commencement. 91% were on the Control-IQ system and 9% on the CamAPS FX system. HCL use demonstrated significant improvements at 3 months in the following: HbA1c in mmol/mol (63.0 vs. 56.6, p = 0.03), TIR (50.5 vs. 67.0, p = 0.001) and time in hypoglycaemia (4.3% vs. 2.8%, p = 0.004). HFS scores showed improved behaviour (34.0 vs. 27.5.9, p = 0.02) and worry (40.2 vs. 31.6, p = 0.03), and HFS-P scores also showed improved behaviour (p < 0.001) and worry (p = 0.01). Our study shows that HCL at 3 months improves glucose control, diabetes management and quality of life measures such as fear and worry of hypoglycaemia for CYP and carers