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

NCT06978387 | Active Not Recruiting FDA Device

• 1 other identifier: TYPE 1_CROSS-SECTIONAL
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (13)

• Time in Range

  Assessment of time in range

  Baseline

• Time below range

  Assessment of time below range

  Baseline

• Time above range

  Assessment of time above range

  Baseline

• Basal Insulin dose

  Assessment of basal insulin doses

  Baseline

• Correction Insulin dose

  Assessment of correction insulin dose

  Baseline

• Pulse wave velocity

  Assessment of pulse wave velocity

  Baseline

• Endothelial glycocalyx

  Assessemnet of the thickness of endothelial glycocalyx

  Baseline

• Global longitudinal strain

  Assessment of global longitudinal strain.

  Baseline

• E score

  Assessement of E score and CAP score.

  Baseline

• Assessment of CAP score

  CAP score

  Baseline

• MED diet

  Assesment of Adherence to MED diet

  Baseline

• Fat mass

  Assessment of fat mass

  Baseline

• Lean Mass

  Assessment of lean mass

  Baseline

Study Arms (1)

Type 1 Diabetes Mellitus

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

Device: Minimed 780G

Interventions

Minimed 780G DEVICE

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

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 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
• Patients with Minimed 780G
• 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

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Vaia Lambadiari

  Attikon General University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine-Endocrinology

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: May 18, 2025
• Study Start: January 1, 2025
• Primary Completion: June 30, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

GR (1)