Efficacy of Automated Insulin Therapy Early Initiated After Diagnosis on Blood Glucose Control in Children and Adolescents With Type 1 Diabetes - Trial NCT06283797

Timeline & Enrollment

Primary Outcome

Glycated hemoglobin (HbA1c) level

Summary

The main objective is to assess whether hybrid closed-loop (HCL) insulin delivery initiated
 early after diagnosis of Type 1 diabetes (T1D) allows a better efficacy on glucose control
 than conventional standard insulin therapy with multiple daily insulin injections (MDI) or
 insulin pumps after one year of use.
 
 The secondary objectives are to assess whether HCL initiated early after diagnosis of T1D
 allows: (1) Higher time spent with glucose level in the near-normal range, (2) Lower time
 spent in hypoglycemia and hyperglycemia, (3) Lower glucose variability, (4) Lower perceived
 burden of diabetes management, (5) Better preserved endogenous insulin secretion, all the
 above after one year of use, (6) Lower occurrence of interventions for hypoglycemia, versus
 conventional standard insulin therapy with MDI or insulin pump.
 
 An optional 1-year extension aims at assessing: (1) Sustainability of above mentioned
 parameters over a second year of HCL use in the group who started HCL early after diagnosis,
 (2) Efficacy on glucose control according to the above mentioned parameters when HCL is
 initiated early after diagnosis vs. after 1 year in the control group of the randomized
 phase.

ICD-10 Classifications