Sally J Rogers, Aubyn Stahmer, Meagan Talbott, Gregory Young, Elizabeth Fuller, Melanie Pellecchia, Angela Barber, Elizabeth Griffith
Feasibility of delivering parent-implemented NDBI interventions in low-resource regions: a pilot randomized controlled study
Journal of neurodevelopmental disorders
advanced hybrid closed loop ahcl therapy improve glycaemic control pregnant women type 1 diabetes however data needed efficacy safety ahcl systems systems minimed 780g currently approved use pregnant women aimed investigate whether minimed 780g improve glycaemic control less hypoglycaemia pregnant women type 1 diabetes cristal doublearm parallelgroup openlabel randomised controlled trial conducted secondary tertiary care specialist endocrinology centres 12 hospitals 11 belgium one netherlands pregnant women aged 1845 years type 1 diabetes randomly assigned 11 ahcl therapy minimed 780g standard insulin therapy standard care median 101 iqr 86116 weeks gestation randomisation done centrally minimisation dependent baseline hba1c insulin administration method centre participants study teams masked group allocation primary outcome proportion time spent pregnancyspecific target glucose range 3578 mmoll measured continuous glucose monitoring cgm 1417 weeks 2023 weeks 2629 weeks 3336 weeks key secondary outcomes overnight time target range time glucose range 35 mmoll overall overnight analyses conducted intentiontotreat basis trial registered clinicaltrialsgov nct04520971 jan 15 2021 sept 30 2022 101 participants screened 95 randomly assigned ahcl therapy n46 standard insulin therapy n49 43 patients assigned ahcl therapy 46 assigned standard insulin therapy completed study baseline 91 958 participants used insulin pumps mean hba1c 65 sd 06 mean proportion time spent target range averaged four time periods 665 sd 100 ahcl therapy group compared 632 124 standard insulin therapy group adjusted mean difference 188 percentage points 95 ci 082 458 p017 overnight time target range higher adjusted mean difference 658 percentage points 95 ci 231 1085 p00026 time range overall adjusted mean difference 134 percentage points 95 ci 219 049 p00020 overnight adjusted mean difference 186 percentage points 95 ci 290 081 p00005 lower ahcl therapy standard insulin therapy participants assigned ahcl therapy reported higher treatment satisfaction unanticipated safety events occurred ahcl therapy pregnant women starting tighter glycaemic control ahcl therapy improve overall time target range improved overnight time target range reduced time range improved treatment satisfaction data suggest minimed 780g safely used pregnancy provides additional benefits compared standard insulin therapy however important refine algorithm better align pregnancy requirements diabetes liga research fund medtronic