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: 1. hybrid closed-loop systems (HCLS) or 2. Sodium glucose co-transporter 2 inhibitors (SGLT-2i) added to MDI or 3. intensification of MDI treatment. Markers of endothelial and cardiovascular function will be assessed at baseline, at 6 and 12 months post-treatment. The primary objactive of the study is to evaluate the effect of HCLS on cardiovacular and endothelial function compared to MDI or SGLT-2i in T1D.
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: 1. HCLS or 2. SGLT-2i as an add-on treatment to MDI or 3. intensification of MDI treatment. 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).
Study Type
OBSERVATIONAL
Enrollment
100
Hybrid Closed-Loop System treatment
SGLT-2 Inhibitor Treatment
Multiple Daily Injection Insulin treatment
Attikon University General Hospital
Athens, Greece
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
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