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

November 17, 2025 updated by: VAIA LAMBADIARI, Attikon Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 12462
        • Attikon University General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with poorly controlled type 1 diabetes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HCL group
Patients will recieve hybrid closed loop system
Device: HCLS
Hybrid Closed-Loop System treatment
SGLT-2i group
Patients will recieve SGLT-2i as add on treatment to multiple daily injections
Drug: SGLT2 inhibitor
SGLT-2 Inhibitor Treatment
MDI group
Patients will recieve intensification of MDI treatment.
Drug: MDI
Multiple Daily Injection Insulin treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulse Wave Velocity
Time Frame: Baseline, Six Months, Twelve months
The investigators will assess pulse wave velocity as a marker of arterial stiffness at baseline, at six and twelve months post-treatment
Baseline, Six Months, Twelve months
Perfused Boundary Region
Time Frame: Baseline, Six Months, Twelve months
The investigators will assess perfused boundary region as a marker of endothelial glycocalyx integrity at baseline, at six and twelve months post-treatment
Baseline, Six Months, Twelve months
Global Longitudinal Strain
Time Frame: Baseline, Six Months, Twelve months
The investigators will assess global londitudinal strain as a marker of myocardial function at baseline, at six and twelve months post-treatment
Baseline, Six Months, Twelve months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central Systolic Blood Pressure
Time Frame: Baseline, Six Months, Twelve months
The investigators will assess central systolic blood pressure as a marker of vascular function at baseline, at six and twelve months post-treatment
Baseline, Six Months, Twelve months
Central Diastolic Blood Pressure
Time Frame: Baseline, Six Months, Twelve months
The investigators will assess central diastolic blood pressure as a marker of vascular function at baseline, at six and twelve months post-treatment
Baseline, Six Months, Twelve months
Augmentation Index
Time Frame: Baseline, Six Months, Twelve months
The investigators will assess Augmentation Index as a marker of vascular function at baseline, at six and twelve months post-treatment
Baseline, Six Months, Twelve months
Flow mediated dilation
Time Frame: Baseline, Six Months, Twelve months
The investigators will assess Flow Mediated Dilation as a marker of endothelial function at baseline, at six and twelve months post-treatment
Baseline, Six Months, Twelve months
Coronary flow reserve
Time Frame: Baseline, Six Months, Twelve months
The investigators will assess Coronary flow reserve at baseline, at six and twelve months post-treatment
Baseline, Six Months, Twelve months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Attikon Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

September 1, 2022

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TYPE 1-HCLS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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