The Association Between Time in Range With Markers of Endothelial and Cardiovascular Function

NCT ID: NCT06810700

Last Updated: 2025-02-05

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

NOT_YET_RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-15

Study Completion Date

2025-09-15

Brief Summary

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In this observaltional study, 90 patients aged \>12 years old with T1DM who are on MiniMed 780G system will be included.We aim to investigate the association between time in range (70-140mg/dl) and time in tight range (70-180mg/dl) with markers of endothelial and cardiovascular function.

Detailed Description

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In this observational study, 90 participants with T1D on MiniMed 780G system will be included. HbA1c, anthropometric measurements, CGM and Insulin Metrics will be assessed in all patients. Moreover, the investigators will assess:

1. the pulse wave velocity, the augmentation index and the central systolic blood pressure which are markers of arterial stiffness
2. the perfused boundary region of subglingulal vessels which is marker of endothelial function
3. the global longitudinal strain which is marker of myocardial function.

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

In this observaltional study, 90 patients aged \>12 years old with T1DM who are on MiniMed 780G system will be included.We aim to investigate the association between markers of endothelial and cardiovascular function with with CGM and insulin metrics, as well as anthropometric measurements, BM, lipid levels, blood pressure.

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. Multiple Daily Injections (Basal Bolus therapy) with Total daily insulin use of great than 8.0 units per day over a 1-week period
5. Clinically able to start the AHCL system
6. History of 3 clinic visits in the last year

Exclusion Criteria

1\. 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

Other Identifiers

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TYPE 1DM_Time in range

Identifier Type: -

Identifier Source: org_study_id

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