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NCT Number: NCT06810700

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

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.

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Key information

About this study

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:

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

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

Treatment and study plan

Minimed 780G

Device

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

Primary outcomes

  1. Endothelial glycocalyx

    Time frame: Baseline

    The association between time in range and the thickness of endothelial glycocalyx

  2. Pulse wave velocity

    Time frame: Baseline

    The association between time in range and pulse wave velocity

  3. Global longitudinal strain

    Time frame: Baseline

    The association between time in range and global longitudinal strain

Sponsors and collaborators

Lead sponsor

Attikon Hospital

Other

Registry information

Official study title

The Association Between Time in Range With Markers of Endothelail an Dcardiovascular Function in Patients With type1 Diabetes Mellitus and Minimed 780G

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 5, 2025
Registry last updated
Feb 5, 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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