An observational study in Type 1 Diabetes, sponsored by Attikon Hospital. Active, not recruiting at 1 site in Greece. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by Attikon Hospital · Observational
This is a prospective, non-randomized, observational cohort study conducted in adult patients with type 1 diabetes.Participants with poorly controlled T1D under multiple daily injection (MDI) treatment will be assigned to one of three treatment groups:
Patients with type 1 diabetes mellitus (T1DM) present subclinical signs of vascular and endothelial dysfunction earlier compared to healthy individuals. Hybrid closed loop systems (HCLS) are currently the gold standard method for glycemic management, however, the data regarding its superiority in terms of the prevention of subclinical vascular and endothelial dysfunction are scarce. The aim of this study is to determine whether treatment with HCLS improves vascular and endothelial function compared to multiple daily injections (MDI) or Sodium glucose co-transporter 2 inhibitors (SGLT-2i) in patients with T1DM. Partcipants with poorly controlled T1DM under MDI treatment, will be assigned to receive either:
We will assess at baseline and 6 and 12 months post-treatment:
(i) glycemic parameters derived via continuous glucose monitoring (GGM) (ii) pulse wave velocity (PWV) (iii)central systolic and diastolic blood pressure (cSBP, cDBP) (iv) the perfused boundary region (PBR) of the sublingual arterial microvessels, as a marker of endothelial glycocalyx integrity.
(v) global longitudinal strain(GLS).
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 576 are open to participants now.
This study's planned enrollment of 100 is below the median of 120 across 748 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →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.
Patients with poorly controlled type 1 diabetes
Exclusion Criteria:
Patients will recieve hybrid closed loop system
Device: HCLS
Patients will recieve SGLT-2i as add on treatment to multiple daily injections
Drug: SGLT2 inhibitor
Patients will recieve intensification of MDI treatment.
Drug: MDI
Hybrid Closed-Loop System treatment
SGLT-2 Inhibitor Treatment
Multiple Daily Injection Insulin treatment
Pulse Wave Velocity
The investigators will assess pulse wave velocity as a marker of arterial stiffness at baseline, at six and twelve months post-treatment
Time frame: Baseline, Six Months, Twelve months
Perfused Boundary Region
The investigators will assess perfused boundary region as a marker of endothelial glycocalyx integrity at baseline, at six and twelve months post-treatment
Time frame: Baseline, Six Months, Twelve months
Global Longitudinal Strain
The investigators will assess global londitudinal strain as a marker of myocardial function at baseline, at six and twelve months post-treatment
Time frame: Baseline, Six Months, Twelve months
Central Systolic Blood Pressure
The investigators will assess central systolic blood pressure as a marker of vascular function at baseline, at six and twelve months post-treatment
Time frame: Baseline, Six Months, Twelve months
Central Diastolic Blood Pressure
The investigators will assess central diastolic blood pressure as a marker of vascular function at baseline, at six and twelve months post-treatment
Time frame: Baseline, Six Months, Twelve months
Augmentation Index
The investigators will assess Augmentation Index as a marker of vascular function at baseline, at six and twelve months post-treatment
Time frame: Baseline, Six Months, Twelve months
Flow mediated dilation
The investigators will assess Flow Mediated Dilation as a marker of endothelial function at baseline, at six and twelve months post-treatment
Time frame: Baseline, Six Months, Twelve months
Coronary flow reserve
The investigators will assess Coronary flow reserve at baseline, at six and twelve months post-treatment
Time frame: Baseline, Six Months, Twelve months
This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Attikon Hospital