MiniMed 780G™ in 2- to 6-Year-Old Children: Safety and Clinical Outcomes After the First 12 Weeks

Abstract

Objective The safety and impact of the advanced hybrid closed-loop (AHCL) system on glycemic outcome in 2–6-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 units/day, 3) HbA1c < 10% (85 mmol/mol), and 4) capability to use insulin pump and continuous glucose monitoring (CGM). The MiniMed 780G™ AHCL in SmartGuard™ Mode was used for 12 weeks. Parental diabetes distress was evaluated with a validated PAID-PR (Problem Areas In Diabetes – Parent, revised) survey. Results No events of diabetic ketoacidosis (DKA) or severe hypoglycemia occurred. Between 0 and 12 weeks, Hba1c (mean change= -2.7 mmol/mol [SD 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 glycaemic control in 2–6-year-old children with type 1 diabetes. Additionally, AHCL is associated with a reduction in parental diabetes distress after 12-week use.