Study of Medtronic 780G Closed-Loop System for Children and Teens With Type 1 Diabetes

What this Trial Is About

This research aims to understand how the Medtronic 780G hybrid closed-loop system affects children and youth with type 1 diabetes in Israel. The study focuses on whether this system improves blood sugar control and psychosocial aspects like quality of life and anxiety. It is a prospective, observational study involving participants aged 7 to 18 years who are using or starting the 780G system as part of their diabetes care. Participants will use the Medtronic 780G system, which combines an insulin pump with continuous glucose monitoring in an automated auto-mode. Data will be collected at six time points baseline start of 780G use, and after 1 month, 3 months, 6 months, 1 year, and 2 years. The study gathers information from medical records, insulin pump and glucose monitor downloads, questionnaires for both patients and parents, bioimpedance measures, dietary records, and sleep diaries. During the study, participants will attend regular diabetes clinic visits where data on demographics, diabetes history, insulin use, glucose levels, and physical activity are recorded. Questionnaires assess quality of life, anxiety, fear of low blood sugar, diabetes management, sleep quality, and nutrition knowledge. Researchers will track key outcomes like time spent in target blood sugar range and HbA1c levels over two years. The study also monitors psychosocial factors and dietary and sleep habits to understand the broader impacts of the 780G system.

Closed-loop Medtronic 780G System in Youth With Type 1 Diabetes