RecruitingNCT06646107

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

Sponsor

Attikon Hospital

Enrollment

240 participants

Start Date

Mar 1, 2025

Study Type

OBSERVATIONAL

Conditions

Type1diabetes

Summary

In this observaltional study, 240 patients aged \>12 years old with T1DM who are on multiple daily injections or insulin pump and are scheduled to start using MiniMed 780G system will be included.We aim to compare patients' adherence to Mediterranean diet (MD) before and 12 weeks after initiation of MiniMed 780G and its association with CGM and insulin metrics, as well as anthropometric measurements, BMI, body composition, lipid levels, blood pressure and gut microbioma. Moreover, at baseline, at six and 12 months, markers of endothelial and cardiovascular function will be also assessed and associated with the use of Minimed 780G and the adherence to MD.

Eligibility

Min Age: 12 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether following a Mediterranean diet affects blood sugar control differently when measured by glucose monitors versus insulin use in children and adults with type 1 diabetes who are starting the MiniMed 780G automated insulin delivery system (a "closed-loop" insulin pump and sensor). **You may be eligible if...** - You have had type 1 diabetes for more than 1 year - Your HbA1c (a 3-month blood sugar average) is below 12.5% - You are older than 7 years - You are currently on a basal-bolus insulin regimen (multiple daily injections) using more than 8 units per day - You are medically ready to start the automated insulin delivery system - You have had at least 3 clinic visits in the past year **You may NOT be eligible if...** - You have had diabetic ketoacidosis (a serious diabetes complication) in the 6 months before the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMInimed 780G

Minimed 780G HCL system (Metronic, Northridge, Ca, USA) is ConformitèEuropëenne(CE)-marked and includes additional functionality aiming to provide further protections from high glucose levels. When the system is used in Auto Mode automatically calculate the insulin dose based on information received from CGM. Signals are converted by the transmitter to sensor glucose values. Sensor values are then transmitted to the insulin pump. Sensor glucose and insulin delivery data are stored by the pump and may be uploaded. The HCL system can be programmed to automatically calculate insulin doses (both basal insulin and correction boluses) based on information received from CGM780G and the adherence to MD.