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

NCT06646107 | Recruiting FDA Device

• 1 other identifier: MED_TYPE 1
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Type1diabetes

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (8)

• Changes in pulse wave velocity(m/s)

  Baseline, 6 months, 12 months

• Changes in endothelial glycocalyx thickness (μm)

  Baseline, 6 months, 12 months

• Changes in global longidutinal strain (%)

  Baseline, 6 months, 12 months

• Changes in CAP (dB/m)

  Baseline, 6 months, 12 months

• Changes in gut microbioma

  Baseline,3 months

Study Arms (1)

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

Interventions

MInimed 780G 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.

Type 1 Diabetes Mellitus

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• HbA1c \< 12.5%
• Age \>7years at the initiation of the system
• Multiple Daily Injections (Basal Bolus therapy) with Total daily insulin use of great than 8.0 units per day over a 1-week period
• Clinically able to start the AHCL system
• History of 3 clinic visits in the last year

You may not qualify if:

• \. Diabetic Ketoacidosis in the 6 months prior to screening visits

Sponsors & Collaborators

• Attikon Hospital: lead

Study Sites (1)

Attikon University General Hospital

Chaïdári, 124 62, Greece

RECRUITING

Central Study Contacts

VAIA LAMBADIARI, Professor

CONTACT

2105831148; vlambad@otenet.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine-Endocrinology

Study Record Dates

• First Submitted: October 13, 2024
• First Posted: October 17, 2024
• Study Start: March 1, 2025
• Primary Completion: August 31, 2025
• Study Completion: January 31, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

GR (1)