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Not yet recruitingNCT06810700Updated Feb 5, 2025

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

An observational study in Type 1 Diabetes, sponsored by Attikon Hospital. Not yet recruiting. Open to participants aged 12 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-05.

Sponsored by Attikon Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 3 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
90
Ages
12 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

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.
02

Conditions studied

  • Type 1 Diabetes
03

In context

Diabetes Mellitus, Type 1

3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.

This study's planned enrollment of 90 is below the median of 120 across 748 observational studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Attikon Hospital is the lead sponsor of 83 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  1. Diabetic Ketoacidosis in the 6 months prior to screening visits
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceMiniMed 780G

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

06

What researchers measure

Primary outcomes

  1. Endothelial glycocalyx

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

    Time frame: Baseline

  2. Pulse wave velocity

    The association between time in range and pulse wave velocity

    Time frame: Baseline

  3. Global longitudinal strain

    The association between time in range and global longitudinal strain

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06810700
Lead sponsor
Attikon Hospital
Responsible party
VAIA LAMBADIARI (Professor of Internal Medicine-Endocrinology, Attikon Hospital) — Principal investigator
First posted
Feb 5, 2025
Start date
Feb 15, 2025 (estimated)
Primary completion
Jun 15, 2025 (estimated)
Completion
Sep 15, 2025 (estimated)
Last update
Feb 5, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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