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

NCT ID: NCT06978387

Last Updated: 2025-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-15

Study Completion Date

2025-09-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type 1 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Type 1 Diabetes Mellitus

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

Minimed 780G

Intervention Type DEVICE

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

Interventions

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Minimed 780G

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

Intervention Type DEVICE

Eligibility Criteria

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

Exclusion Criteria

Diabetic Ketoacidosis in the 6 months prior to screening visits
Minimum Eligible Age

12 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Attikon Hospital

OTHER

Sponsor Role lead

Responsible Party

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VAIA LAMBADIARI

Professor of Internal Medicine-Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vaia Lambadiari

Role: PRINCIPAL_INVESTIGATOR

Attikon General University Hospital

Locations

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Attikon University General Hospital

Chaïdári, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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VAIA LAMBADIARI

Role: CONTACT

2105831148

Facility Contacts

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Vaia Lambadiari, Professor

Role: primary

2105831148

Other Identifiers

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TYPE 1_CROSS-SECTIONAL

Identifier Type: -

Identifier Source: org_study_id

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