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

NCT06810700 | Not Yet Recruiting FDA Device

• 1 other identifier: TYPE 1DM_Time in range
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (3)

• Endothelial glycocalyx

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

  Baseline

• Pulse wave velocity

  The association between time in range and pulse wave velocity

  Baseline

• Global longitudinal strain

  The association between time in range and global longitudinal strain

  Baseline

Study Arms (1)

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.

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

patients aged \>12 years old with T1DM who 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
• 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

You may not qualify if:

• \. Diabetic Ketoacidosis in the 6 months prior to screening visits

Sponsors & Collaborators

• Attikon Hospital: lead

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 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 31, 2025
• First Posted: February 5, 2025
• Study Start: February 15, 2025
• Primary Completion: June 15, 2025
• Study Completion: September 15, 2025
• Last Updated: February 5, 2025

Record last verified: 2025-01