Assessing the Effect of Advanced Hybrid Closed Loop System MiniMed 780G with GS4 Glucose Sensor in Newly Diagnosed Children and Adolescents with Type 1 Diabetes on Glycemic Control and Patient Reported Outcomes Compared to Standard Insulin Therapy Historical Data

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)