A multicentre prospective evaluation of the benefits of two advanced hybrid closed-loop systems in glucose control and patient-reported outcomes in a real-world setting
Background. Advanced hybrid closed-loop systems (AHCL) have been shown to improve glycaemic control and patient-reported outcomes in type 1 diabetes (T1D). The aim was to analyse the outcomes of two commercially available AHCL in real-life. Methods. A prospective study was performed, including adolescents and adults with T1D, AHCL-naïve, from 14 centres, who initiated the use of MM780G with SmartGuardTM or Tandem t:slimX2TM with Control-IQ. Baseline and 3-month evaluations were performed, assessing HbA1c, time in different glycaemic ranges, and patient-reported outcomes. The primary outcome was the between-group time in range 70-180 mg/dl (TIR) difference from beginning to end of follow-up. Results. 150 participants were included, with 75 initiating each system (age: 39.9±11.4 years (16-72), 64% female, diabetes duration: 21.6±11.9 years). TIR increased from 61.53±14.01% to 76.17±9.48% (p<0.001), with no between-group differences (p=0.591). HbA1c decreased by 0.56% (95%CI: 0.44%,0.68%) (6 mmol/mol, 95%CI: 5,7) (p<0.001), from 7.43±1.07% to 6.88±0.60% (58±12 to 52±7 mmol/mol) in the MM780G group, and from 7.14±0.70% to 6.56±0.53% (55±8 to 48±6 mmol/mol) in the Control-IQ group (both p<0.001 to baseline, p=0.819 between groups). No superiority of one AHCL over the other regarding fear of hypoglycaemia or quality of life was found. Improvement in diabetes-related distress was higher in Control-IQ users (p=0.012). Sleep quality was improved (PSQI: from 6.94±4.06 to 6.06±4.05, p = 0.004), without differences between systems. Experience with AHCL, evaluated by the INSPIRE measures, exceeded the expectations. Conclusion. The two AHCL provide significant improvement in glucose control and satisfaction, with no superiority of one AHCL over the other. Keywords: type 1 diabetes, closed-loop system, glucose control, patient-reported outcomes. Article Highlights • Why did we undertake this study? Advanced hybrid closed-loop (AHCL) therapy should be offered to all people living with type 1 diabetes. Up to date, information about direct comparison between different AHCL options is scarce. • What did we find? Here, we describe the effect of MM780G with SmartGuardTM and the Tandem t:slimX2TM with Control-IQ over glycemic control and patient-reported outcomes among adolescents and adults with type 1 diabetes. • What are the implications of our findings? The two AHCL systems provide significant improvement in glucose control and satisfaction, with no superiority of one system over the other.