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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

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Where it's running

• Attikon University General Hospital
  Chaïdári, Greece Recruiting

Study contacts

• Study coordinator: VAIA LAMBADIARI, Professor
• Email: vlambad@otenet.gr
• Phone: 2105831148

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.