RECRUITINGOBSERVATIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Clinical diagnosis of type 1 diabetes \>1 year prior to consent date. Diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required. 2. HbA1c \< 12.5% 3. Age \>7years at the initiation of the system 4. Multiple Daily Injections (Basal Bolus therapy) with Total daily insulin use of great than 8.0 units per day over a 1-week period 5. Clinically able to start the AHCL system 6. History of 3 clinic visits in the last year Who Should NOT Join This Trial: 1\. Diabetic Ketoacidosis in the 6 months prior to screening visits \- Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Clinical diagnosis of type 1 diabetes \>1 year prior to consent date. Diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required. 2. HbA1c \< 12.5% 3. Age \>7years at the initiation of the system 4. Multiple Daily Injections (Basal Bolus therapy) with Total daily insulin use of great than 8.0 units per day over a 1-week period 5. Clinically able to start the AHCL system 6. History of 3 clinic visits in the last year Exclusion Criteria: 1\. Diabetic Ketoacidosis in the 6 months prior to screening visits \-

Treatments Being Tested

DEVICE

MInimed 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.

Locations (1)

Attikon University General Hospital

Chaïdári, Greece