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NCT Number: NCT06978387

The Association Between Glycemic Metrics and Cardiovascular Markers in Patients With Type 1 Diabetes.

In this cross-sectioanl study, 90 patients aged >12 years old with T1DM who are on MiniMed 780G system will be included.The investigators aim to assesse the association of patients' adherence to Mediterranean diet (MD) with CGM and insulin metrics, as well as anthropometric measurements, BMI, lipid levels and blood pressure.Moreover, markers of endothelial, cardiovascular and liver function will be also assessed and associated with the use of Minimed 780G and the adherence to MD.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Attikon University General Hospital

Chaïdári, 124 62, Greece

About this study

This cross-sectional study will include 90 participants, children adolescents and young adults (12> years old) with T1D that are on MiniMed 780G system. Participants will be evaluated for adherence to Meditteranean Diet (MD) with PREDIMED questionnaire. HbA1c, CGM and Insulin Metrics, anthropometric measurements, blood pressure and lipid leves will be aso evalutaed. Markers of endothelial cardiovascular and liver function will also be assessed.

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
  • Patients with Minimed 780G
  • History of 3 clinic visits in the last year

Exclusion criteria

Diabetic Ketoacidosis in the 6 months prior to screening visits

Treatment and study plan

Minimed 780G

Device

patients aged >12 years old with T1DM who are on MiniMed 780G

Primary outcomes

  1. Time in Range

    Time frame: Baseline

    Assessment of time in range

  2. Time below range

    Time frame: Baseline

    Assessment of time below range

  3. Time above range

    Time frame: Baseline

    Assessment of time above range

  4. Basal Insulin dose

    Time frame: Baseline

    Assessment of basal insulin doses

  5. Correction Insulin dose

    Time frame: Baseline

    Assessment of correction insulin dose

  6. Pulse wave velocity

    Time frame: Baseline

    Assessment of pulse wave velocity

  7. Endothelial glycocalyx

    Time frame: Baseline

    Assessemnet of the thickness of endothelial glycocalyx

  8. Global longitudinal strain

    Time frame: Baseline

    Assessment of global longitudinal strain.

  9. E score

    Time frame: Baseline

    Assessement of E score and CAP score.

  10. Assessment of CAP score

    Time frame: Baseline

    CAP score

  11. MED diet

    Time frame: Baseline

    Assesment of Adherence to MED diet

  12. Fat mass

    Time frame: Baseline

    Assessment of fat mass

  13. Lean Mass

    Time frame: Baseline

    Assessment of lean mass

Sponsors and collaborators

Lead sponsor

Attikon Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 18, 2025
Registry last updated
Apr 14, 2026

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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