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

Attikon University Hospital

Status: Active, not recruiting

Conditions: Type 1 Diabetes

Treatments: Drug: MDI; Device: HCLS; Drug: SGLT2 inhibitor

Study type: Observational

Funder types: Other

Identifiers

NCT07241702

TYPE 1-HCLS

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age >18 years
• history of type 1 diabetes with diabetes duration > 5 years
• HbA1c ≥ 7% and ≤ 10%
• eGFR> 60ml/min/1,73m2.

Exclusion criteria

• history of malignancy within the last 5 years
• severe hepatic impairment
• cardiovascular events within the recent three months

Trial design

100 participants in 3 patient groups

HCL group

Description:

Patients will recieve hybrid closed loop system

Treatment:

Device: HCLS

SGLT-2i group

Description:

Patients will recieve SGLT-2i as add on treatment to multiple daily injections

Treatment:

Drug: SGLT2 inhibitor

MDI group

Description:

Patients will recieve intensification of MDI treatment.

Treatment:

Drug: MDI