Using the MiniMed 780G Advanced Hybrid Closed Loop System with GS4 Sensor in Children and Adolescents Aged 7 to 17 Newly Diagnosed with Type 1 Diabetes to Improve Blood Sugar Control Compared to Standard Insulin Therapy

What this Trial Is About

Researchers are evaluating the glycemic control in children and adolescents aged 7 to 17 years who have been newly diagnosed with type 1 diabetes. This observational study compares the use of the Advanced Hybrid Closed Loop AHCL system MiniMed 780G with the GS4 calibration-free glucose sensor combined with continuous glucose monitoring, against historical data of those treated with multiple daily insulin injections MDI. The study aims to assess blood sugar management and patient-reported outcomes over time. Participants will use the MiniMed 780G AHCL system starting directly after their type 1 diabetes diagnosis. This device continuously monitors glucose levels and adjusts insulin delivery automatically to help control blood sugar. The initial study period lasts 3 months, followed by a 3-month extension phase to further observe the effects of the system. Throughout the study, participants will be monitored for glucose control using continuous glucose monitoring metrics and HbA1c measurements at 3 and 6 months. Additional assessments include insulin usage, time spent above and below target glucose ranges, fear of hypoglycemia, quality of life questionnaires, and biological markers such as fasting c-peptide. Participants will also need to wear study devices, follow specific instructions, and upload their data regularly. The total study duration is 6 months including the extension phase.

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)