Real-World Glycemic and Person-Reported Outcomes After Tandem Control-IQ Initiation in Children With Type 1 Diabetes.

Abstract

Real-world data add value to outcomes from randomized controlled trials on the use of hybrid closed-loop systems in the management of children and adolescents with type 1 diabetes. This multicenter prospective observational cohort study assessed real-world changes in glycemic and person-reported outcomes 1 year after Control-IQ initiation in children and adolescents with type 1 diabetes. Between December 2021 and December 2022, all children aged 6-18 years who started Control-IQ at 13 Belgian centers were consecutively recruited. Data were collected at start of Control-IQ and after 4, 8, and 12 months. Person-reported outcomes were evaluated through questionnaires (Diabetes Quality of Life for Youth [DQOLY], Hypoglycemia Fear Survey [HFS], HAPPI-D). Data are reported as mean ± SD or least-squares mean (95% CI). A total of 114 children were included, with a mean age of 12.0 ± 3.2 years and of whom 61.4% were girls. Time in range (3.9-10.0 mmol/L) increased from start (51.6% [47.6-55.5]) to 12 months (64.4% [61.2-67.5]) (P < 0.001). After 12 months, HbA1c decreased from 62 mmol/mol (60-65) (7.8% [7.6-8.1]) to 54 mmol/mol (52-57) (7.1% [6.9-7.3]) and time <3.9 mmol/L from 3.9% (3.1-4.8) to 2.7% (1.9-3.5) (all P < 0.001). Children scored better on DQOLY satisfaction (70.4 [67.8-73.0] vs 74.0 points [71.3-76.6]) and DQOLY impact (54.6 [50.9-58.3] vs 51.3 points [47.4-55.1]), and parents on HAPPI-D (22.5 [21.1-23.9] vs 19.6 points [18.2-21.0]) and HFS worry (25.0 [21.6-28.4] vs 20.3 points [17.0-23.5]) (all P < 0.001). Children missed fewer days of school (287 vs 30 days/100 person-years, P < 0.001) and parents missed fewer days of work (247 vs 47 days/100 person-years, P < 0.001). One-year use of Control-IQ was associated with improved glycemic management, more diabetes-related quality of life and fewer school/work absences.