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NCT Number: NCT06646107

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.

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Key information

Conditions

Type1diabetes

Age range

12 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Attikon University General Hospital

Chaïdári, 124 62, Greece

Location status: Recruiting

Location contact

Vaia Lambadiari, Professor

CONTACT

[email protected]

2105831148

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Diabetic Ketoacidosis in the 6 months prior to screening visits

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Treatment and study plan

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.

Primary outcomes

  1. Changes in Hba1c

    Time frame: Baseline, 3 months

    Differences in HbA1c at baseline and 3 months after the initiation of MiniMed 780G

  2. Changes in TIR

    Time frame: Baseline, 3 months

    Changes in TIR at baseline and 3 months after the initiation of MiniMed 780G

  3. Changes in TBR

    Time frame: Baseline, 3 months

    Changes in TBR at baseline and 3 months after the initiation of MiniMed 780G

  4. Changes in TAR

    Time frame: Baseline, 3 months

    Changes in TAR at baseline and 3 months after the initiaton of MiniMed 780G

  5. Changes in bolus doses

    Time frame: Baseline, 3 months

    Changes in bolus dosed at baseline and 3 months after the initiation of MiniMed 780G

  6. Changes in basal doses

    Time frame: Baseline, 3 months

    Changes in basal doses at baseline and 3 months after the initiation of MiniMed 780G

  7. Changes in autocorrection doses

    Time frame: Baseline, 3 months

    Changes in autocorrection doses between baseline and 3 months after the initiation of MiniMed 780G:

Secondary outcomes

  1. Changes in pulse wave velocity(m/s)

    Time frame: Baseline, 6 months, 12 months

    Changes in pulse wave velocity at baseline and at 6 and 12 months after the initiation of MiniMed 780G

  2. Changes in endothelial glycocalyx thickness (μm)

    Time frame: Baseline, 6 months, 12 months

    Changes in endothelial glycocalyx thickness at baseline and at 6 and 12 months after the initiation of MiniMed 780G

  3. Changes in global longidutinal strain (%)

    Time frame: Baseline, 6 months, 12 months

    Changes in global longidutinal strain at baseline and at 6 and 12 months after the initiation of MiniMed 780G

  4. Changes in CAP (dB/m)

    Time frame: Baseline, 6 months, 12 months

    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).

  5. Changes in gut microbioma

    Time frame: Baseline,3 months

    Changes in gut microbioma at baseline and at 3 months after the initiation of MiniMed 780G.

  6. Changes in coronary flow reserve

    Time frame: Baseline, 6 months, 12 months

    Changes in coronary flow reserve at baseline, at six months and at 12 months after the initiation of MiniMed 780G.

  7. Changes in central aortic blood pressure (mmHg)

    Time frame: Baseline, 6 months, 12 months

    Changes in central aortic blood pressure at baseline and at 6 and 12 months after the initiation of MiniMed 780G.

  8. Changes in Ε score (Kpa)

    Time frame: Baseline, 6 months, 12 months

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

VAIA LAMBADIARI, Professor

CONTACT

[email protected]

2105831148

Sponsors and collaborators

Lead sponsor

Attikon Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Oct 17, 2024
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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