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ACTIVE NOT RECRUITING
NCT07241702

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

Sponsor: Attikon Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2019-09-01

Completion Date

2025-12-01

Last Updated

2025-11-21

Healthy Volunteers

No

Conditions

Interventions

DEVICE

HCLS

Hybrid Closed-Loop System treatment

DRUG

SGLT2 inhibitor

SGLT-2 Inhibitor Treatment

DRUG

MDI

Multiple Daily Injection Insulin treatment

Locations (1)

Attikon University General Hospital

Athens, Greece