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Objective: The safety and impact of the advanced hybrid closed-loop (AHCL) system on glycemic outcome in 2- to 6-year-old children with type 1 diabetes and the diabetes distress of caregivers were evaluated. Research Design and Methods: This was an open-label prospective study ( n = 35) with historical controls matched by treatment unit, diabetes duration, age, gender, and baseline treatment modality. The inclusion criteria were (1) type 1 diabetes diagnosis >6 months, (2) total daily dose of insulin ≥8 U/day, (3) HbA1c <10% (85 mmol/mol), and (4) capability to use insulin pump and continuous glucose monitoring. The MiniMed 780G™ AHCL in SmartGuard™ Mode was used for 12 weeks. Parental diabetes distress was evaluated with a validated Problem Areas In Diabetes—Parent, revised (PAID-PR) survey. Results: No events of diabetic ketoacidosis or severe hypoglycemia occurred. Between 0 and 12 weeks, HbA1c (mean change = −2.7 mmol/mol standard deviation 5.7, P = 0.010), mean sensor glucose value (SG) (−0.8 mmol/L 1.0, P < 0.001), and time above range (TAR) (−8.6% 9.5, P < 0.001) decreased and time in range (TIR) (8.3% 9.3, P < 0.001) increased significantly, whereas no significant change in time below range (TBR) was observed. At the same time, PAID-PR score decreased from 37.5 (18.2) to 27.5 (14.8) ( P = 0.006). Conclusions: MiniMed 780G™ AHCL is a safe system and 12-week use was associated with improvements in glycemic control in 2- to 6-year-old children with type 1 diabetes. In addition, AHCL is associated with a reduction in parental diabetes distress after 12-week use. ClinicalTrials.gov registration number: NCT04949022
Pulkkinen et al. (Tue,) studied this question.