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

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.

Study Overview

• Status: Recruiting
• Conditions: Type1diabetes
• Intervention / Treatment: Device: MInimed 780G

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.

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Vaia Lambadiari, Professor; Phone Number: 2105831148; Email: vlambad@otenet.gr

Study Locations

• Greece
  • Chaïdári, Greece, 124 62
    • Recruiting
    • Attikon University General Hospital
    • Contact: Vaia Lambadiari, Professor; Phone Number: 2105831148; Email: vlambad@otenet.gr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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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Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Hba1c	Differences in HbA1c at baseline and 3 months after the initiation of MiniMed 780G	Baseline, 3 months
Changes in TIR	Changes in TIR at baseline and 3 months after the initiation of MiniMed 780G	Baseline, 3 months
Changes in TBR	Changes in TBR at baseline and 3 months after the initiation of MiniMed 780G	Baseline, 3 months
Changes in TAR	Changes in TAR at baseline and 3 months after the initiaton of MiniMed 780G	Baseline, 3 months
Changes in bolus doses	Changes in bolus dosed at baseline and 3 months after the initiation of MiniMed 780G	Baseline, 3 months
Changes in basal doses	Changes in basal doses at baseline and 3 months after the initiation of MiniMed 780G	Baseline, 3 months
Changes in autocorrection doses	Changes in autocorrection doses between baseline and 3 months after the initiation of MiniMed 780G:	Baseline, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in pulse wave velocity(m/s)	Changes in pulse wave velocity at baseline and at 6 and 12 months after the initiation of MiniMed 780G	Baseline, 6 months, 12 months
Changes in endothelial glycocalyx thickness (μm)	Changes in endothelial glycocalyx thickness at baseline and at 6 and 12 months after the initiation of MiniMed 780G	Baseline, 6 months, 12 months
Changes in global longidutinal strain (%)	Changes in global longidutinal strain at baseline and at 6 and 12 months after the initiation of MiniMed 780G	Baseline, 6 months, 12 months
Changes in CAP (dB/m)	Changes in liver steatosis at baseline and at 6 and 12 months after the initiation of MiniMed 780G as assessed by the measurement of CAP. CAP score will be used as an index of liver fat content, with normal values being < 238 dB/m. <237 dB/m (S0, no steatosis), 237 -259 dB/m (S1, mild steatosis), 259 -291 dB/m (S2, moderate steatosis), and 291 -400 dB/m (S3,severe steatosis). E score will be used as an index of liver fibrosis. The cut-off values for fibrosis (F) were as follows:(1) <5.5 kPa (F0, no fibrosis), (2) 5.5-8.0 kPa (F1, mild fibrosis), (3) 8.0-10.0 kPa (F2, moderate fibrosis),(4) 11.0-16.0 kPa (F3, severe fibrosis), and (5) >16.0 kPa (F4, cirrhosis).	Baseline, 6 months, 12 months
Changes in gut microbioma	Changes in gut microbioma at baseline and at 3 months after the initiation of MiniMed 780G.	Baseline,3 months
Changes in coronary flow reserve	Changes in coronary flow reserve at baseline, at six months and at 12 months after the initiation of MiniMed 780G.	Baseline, 6 months, 12 months
Changes in central aortic blood pressure (mmHg)	Changes in central aortic blood pressure at baseline and at 6 and 12 months after the initiation of MiniMed 780G.	Baseline, 6 months, 12 months
Changes in Ε score (Kpa)	Changes in liver steatosis at baseline and at 6 and 12 months after the initiation of MiniMed 780G as assessed by E score. E score will be used as an index of liver fibrosis. The cut-off values for fibrosis (F) were as follows:(1) <5.5 kPa (F0, no fibrosis), (2) 5.5-8.0 kPa (F1, mild fibrosis), (3) 8.0-10.0 kPa (F2, moderate fibrosis),(4) 11.0-16.0 kPa (F3, severe fibrosis), and (5) >16.0 kPa (F4, cirrhosis).	Baseline, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Attikon Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Actual): August 31, 2025
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: October 13, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 17, 2024

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 15, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: MED_TYPE 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes