Mediterranean diet adherence in people with type 1 diabetes starting the MiniMed 780G

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

We will test whether sticking to a Mediterranean diet changes CGM and insulin metrics in people with type 1 diabetes who are starting the MiniMed 780G system.

Quick facts

• Study type: Observational
• Enrollment: 240 (estimated)
• Ages: 12 Years to 80 Years
• Sex: All
• Sponsor: Attikon Hospital (Academic / other)
• Locations: 1 site (Chaïdári)
• Trial ID: NCT06646107 on ClinicalTrials.gov

What this trial studies

This observational project will enroll 240 children, adolescents and young adults with type 1 diabetes across Italy, Greece and Israel who are scheduled to begin the MiniMed 780G system. After a 7-day run-in participants complete a 7-day food diary and the PREDIMED questionnaire, receive a one-hour Mediterranean diet counseling session, then start the 780G and are followed for 12 weeks with baseline and 12-week measurements. Key outcomes include HbA1c, CGM and insulin metrics, anthropometrics, body composition, blood pressure, lipids and gut microbiome, while endothelial and cardiovascular markers will be measured at baseline, 6 and 12 months with an optional extension to one year. The analysis compares diet adherence before and after device initiation and relates adherence scores to glucose control and insulin use metrics.

Who should consider this trial

Good fit: People with type 1 diabetes who are on multiple daily injections or an insulin pump, are planning to start the MiniMed 780G system, and meet clinical entry criteria (for example HbA1c <12.5% and clinically able to start AHCL) are ideal candidates.

Not a fit: Patients who are not starting the MiniMed 780G, who had diabetic ketoacidosis within the prior six months, or who cannot attend regional in-person visits are unlikely to gain direct benefit from this project.

Why it matters

Potential benefit: If successful, the results could help patients and clinicians know whether following a Mediterranean diet improves glucose control or insulin needs after starting the MiniMed 780G.

How similar studies have performed: Previous studies show automated insulin delivery systems like the MiniMed 780G improve CGM metrics and Mediterranean-style diets are linked to better cardiometabolic markers, but combining diet adherence with AHCL outcomes is relatively novel.

Eligibility criteria

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

\-

Where this trial is running

Chaïdári

• Attikon University General Hospital — Chaïdári, Greece (Recruiting)

Study contacts

• Study coordinator: VAIA LAMBADIARI, Professor

Conditions Type1diabetes