NCT07241702

EFFECT OF HYBRID CLOSED-LOOP SYSTEMS ON CARDIOVASCULAR MARKERS IN TYPE 1 DIABETES.

The Effect of Hybrid Closed-loop Systems on Markers of Endothelial, Myocardial and Vascular Function in Patients With Type 1 Diabetes.

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Attikon Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	HCLS	Hybrid Closed-Loop System treatment
DRUG	SGLT2 inhibitor	SGLT-2 Inhibitor Treatment
DRUG	MDI	Multiple Daily Injection Insulin treatment

Timeline

• Start date: 2019-09-01
• Primary completion: 2022-09-01
• Completion: 2025-12-01
• First posted: 2025-11-21
• Last updated: 2025-11-21

Locations

1 site across 1 country: Greece