Real-world glycaemic and person-reported outcomes one year after Tandem Control IQ™ initiation in children and adults with type 1 diabetes

Abstract

Background and aims: Real-world (RW) evidence complements outcomes from RCTs on the use of hybrid closed-loop systems in the management of people with type 1 diabetes (T1D). This 12-month prospective observational study evaluated the RW impact of Tandem Control IQ TM on glycemic control and person-reported outcomes (PROs) in children ≥6 years and adults with T1D. Materials and methods: Between Oct 2021 and Dec 2022, all children (n = 114) and adults (n = 473) with T1D who started Tandem Control IQ TM were recruited at 18 Belgian centers. Data were prospectively collected at start, and 4, 8 and 12 months of standard follow-up. PROs were evaluated through validated questionnaires. Data are reported as mean ± SD or least-squares mean (95% CI). Results: Most children were girls (61%), white (79%), with a mean age of 12 ± 3 years. They had T1D for 6 ± 4 years and the majority (81%) used an insulin pump before. TIR increased from start to 4 months (51.6% [47.6-55.5] to 67.0% [63.8-70.2], p<0.001) and was sustained up to 12 months (64.4% [61.2-67.5], p<0.001). After 12 months, HbA1c decreased from 7.8% (7.6-8.1) to 7.1% (6.9-7.3), time <70 mg/dL from 3.9% (3.1-4.8) to 2.7% (1.9-3.5), time >180 mg/dL from 44.1% (39.8-48.5) to 32.9% (29.2-36.5), and time >250 mg/dL from 21.7% (17.9-25.5) to 13.0% (10.7-15.3) (all p<0.001).