NCT06646107 Adherence to Mediterranean Diet in Type 1 Diabetes Initiating Minimed 780G: Glucose Metrics vs Insulin Metrics, is There a Difference
| NCT ID | NCT06646107 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Attikon Hospital |
| Condition | Type1diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 240 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2025-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 240 participants in total. It began in 2025-03-01 with a primary completion date of 2025-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06646107 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 80 Years, studying Type1diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06646107 currently recruiting?
Yes, NCT06646107 is actively recruiting participants. Contact the research team at vlambad@otenet.gr for enrollment information.
Where is the NCT06646107 trial being conducted?
This trial is being conducted at Chaïdári, Greece.
Who is sponsoring the NCT06646107 clinical trial?
NCT06646107 is sponsored by Attikon Hospital. The trial plans to enroll 240 participants.
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