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

NCT ID: NCT06646107

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-01-31

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.

Detailed Description

This observational study will include 240 participants (80 participants per country) from IGI region (Italy, Greece and Israel), children adolescents and young adults (12> years old) with T1D that are on multiple daily injections or insulin pump and are scheduled to start using MiniMed 780G system. After a 7-day run-in period, participants will be evaluated with food intake log and adherence to Meditteranean Diet (MD) with PREDIMED questionnaire. One hour session on MD and healthy impact on Diabetes will be provided to all participants and will be assigned to initiate MiniMed 780G and followed for 12 weeks. HbA1c, CGM and Insulin Metrics, anthropometric measurements, body composition, blood pressure and lipid leves as well a gut microbioma will be performed at baseline and 12 weeks, after MiniMed 780G initiation. A 7-day food diary logbook will be collected to identify the amount and type of the food at baseline and at the end of the study. At baseline, at 6 and at 12 months, markers of endothelial and cardiovascular function will also be assessed. An extension phase will include additional 3 and 6, which concludes one year of follow-up.

Conditions

Type1diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Type 1 Diabetes Mellitus

patients aged \>12 years old with T1DM who are on multiple daily injections or insulin pump and are scheduled to start using MiniMed 780G

MInimed 780G

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

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• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Attikon Hospital

OTHER

Sponsor Role: lead

Responsible Party

VAIA LAMBADIARI

Professor of Internal Medicine-Endocrinology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Attikon University General Hospital

Chaïdári, , Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

VAIA LAMBADIARI, Professor

Role: CONTACT

vlambad@otenet.gr

2105831148

Facility Contacts

Vaia Lambadiari, Professor

Role: primary

vlambad@otenet.gr

2105831148

Other Identifiers

MED_TYPE 1

Identifier Type: -

Identifier Source: org_study_id