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The problem
Intervention: t:slim X2 insulin pump with Control-IQ automated insulin delivery technology
Who it was tested with: 253 children with type 1 diabetes aged 0.5-10 years (131 aged 0.5-5 years, 122 aged 6-10 years) from 32 Italian diabetes centers.
The same group is measured before the intervention and again afterwards, with a baseline and an endline and sometimes a midline. Change is visible, but other causes cannot be ruled out.
"In this longitudinal, observational study conducted from 2020 to 2023, data were collected from 32 Italian centers on children <11 years diagnosed with type 1 diabetes for at least six months and using the t:slim X2 with Control-IQ technology (CIQ). Participants were grouped into 0.5-5 years or 6-10 years at CIQ initiation. Primary endpoints were the percentage of time spent in range (TIR, 70-180 mg/dL) and in tight range (TITR, 70-140 mg/dL)...evaluated according to children's demographic, socioeconomic, and clinical characteristics using mixed-effects models for repeated measures." The study measured glycemic outcomes prospectively across multiple timepoints in two age-stratified cohorts, providing evidence of sustained improvement without a control group.
Observational design without randomized comparison group; cannot definitively separate the effect of the technology from increased parental attention and engagement; limited to Italian healthcare setting; one case of DKA occurred, suggesting potential risks require continued monitoring
Across countries and designs
2 studies · 1 country
