A Multicenter Prospective Evaluation of the Benefits of Two Advanced Hybrid Closed-Loop Systems in Glucose Control and Patient-Reported Outcomes in a Real-world Setting

Abstract

OBJECTIVE Advanced hybrid closed-loop systems (AHCL) have been shown to improve glycemic control and patient-reported outcomes in type 1 diabetes. The aim was to analyze the outcomes of two commercially available AHCL in real life. RESEARCH DESIGN AND METHODS A prospective study was performed, including adolescents and adults with type 1 diabetes, AHCL naïve, from 14 centers, who initiated the use of MM780G with SmartGuard or Tandem t:slimX2 with Control-IQ. Baseline and 3-month evaluations were performed, assessing HbA1c, time in different glycemic ranges, and patient-reported outcomes. The primary outcome was the between-group time in range 70–180 mg/dL difference from beginning to end of follow-up. RESULTS One hundred fifty 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). Time in range 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 hypoglycemia 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. CONCLUSIONS The two AHCL provide significant improvement in glucose control and satisfaction, with no superiority of one AHCL over the other.

Comment on Beato-Víbora et al. A Multicenter Prospective Evaluation of the Benefits of Two Advanced Hybrid Closed-Loop Systems in Glucose Control and Patient-Reported Outcomes in a Real-World Setting. Diabetes Care 2024;47:216–224

“…We have read with great interest in Diabetes Care the results from the recent multicenter real-world prospective study conducted by Beato-V ıbora et al (1), comparing glucose and patient-reported outcomes 3 months after advanced hybrid closed-loop (AHCL) insulin delivery system initiation (either Medtronic Smart-Guard 780G and Tandem T-Slim Control-IQ users). The authors concluded, based on continuous glucose monitoring from 150 participants (87% of whom are aged $25 years), that the AHCL systems provided significant and similar improvement in glucose control, partly in line with a recent publication from our group (2).…”