Clinical Trial

Effect of Advanced Hybrid Closed Loop System, MiniMed 780G in Newly Diagnosed Children and Adolescents With Type 1 Diabetes on Glycemic Control and Patient Reported Outcomes Compared to Standard Insulin Therapy Historical Data (AHCL in New Onset T1D Children Study)

Recruiting
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Record status
This record was last updated April 9, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
The objective of this study is to evaluate glycemic control of users of the AHCL system MiniMed 780G with GS4 calibration-free sensor in children and adolescents with newly diagnosed T1D implemented directly upon T1D diagnosis in combination with continuous glucose monitoring system (CGMS) compared with those treated with MDI retrieved from historical data- in a single- arm open-label prospective observational study, assessed at 3 months. After the initial study period there will be a 3month extension phase of the study.
Trial Details
NCT Number NCT06919029
Lead Sponsor National and Kapodistrian University of Athens
Collaborators: Aghia Sophia Children's Hospital of Athens
Conditions Diabetes Mellitus, Type I
Enrollment 30 participants
Start Date 2025-04
Primary Completion 2025-12 (estimated)
Study Completion 2026-04 (estimated)
Updated on ClinicalTrials.gov 2025-04-09