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)

RecruitingOBSERVATIONAL
Enrollment

30

Participants

Timeline

Start Date

April 30, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

April 30, 2026

Conditions
Diabetes Mellitus, Type I
Interventions
DEVICE

Advanced Hybrid Closed Loop from onset of type 1 diabetes in children

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 Locations (1)

11527

RECRUITING

"First Department of Pediatrics, National and Kapodistrian University of Athens, Medical School, Aghia Sophia Children's Hospital", Athens

All Listed Sponsors
collaborator

Aghia Sophia Children's Hospital of Athens

OTHER

lead

National and Kapodistrian University of Athens

OTHER