Study of Mediterranean Diet Adherence in Type 1 Diabetes Patients Starting MiniMed 780G Insulin Pump System Comparing Glucose and Insulin Metrics with 12-Week Follow-Up

What this Trial Is About

Researchers are studying patients aged over 12 years with Type 1 Diabetes Mellitus T1DM who are on multiple daily injections or insulin pumps and are about to start using the MiniMed 780G system. This observational study aims to compare patients adherence to the Mediterranean Diet before and 12 weeks after starting the MiniMed 780G, and to explore how this relates to glucose monitoring, insulin use, body measurements, blood pressure, lipid levels, and gut microbiome changes. The study also assesses markers of heart and blood vessel function at baseline, six months, and twelve months. Participants will be monitored after a 7-day run-in period where their food intake and adherence to the Mediterranean Diet are recorded using a questionnaire and food diary. Everyone will receive a one-hour session about the Mediterranean Diet and its impact on diabetes before starting the MiniMed 780G system. The study measures various health indicators like HbA1c, continuous glucose monitoring CGM and insulin metrics, body composition, blood pressure, lipid levels, and gut microbiome at baseline and after 12 weeks of using the device. Additional heart and vascular markers will be checked at baseline, six, and twelve months, with an extension phase lasting up to one year. During the study, participants will keep detailed food diaries, and researchers will collect data on glucose control, insulin doses, body measurements, and cardiovascular health. The MiniMed 780G system automatically calculates insulin doses based on glucose sensor readings. The study evaluates changes in glucose control measures, insulin dosing, and cardiovascular function over time. Participants are followed closely for one year, with evaluations at several time points to understand the effects of the device and diet adherence on their health.

Adherence to Mediterranean Diet in Type 1 Diabetes Initiating Minimed 780G: Glucose Metrics vs Insulin Metrics, is There a Difference