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NCT Number: NCT07241702

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Attikon University General Hospital

Athens, 12462, Greece

About this study

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:

  • HCLS or
  • SGLT-2i as an add-on treatment to MDI or
  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HCLS

Device

Hybrid Closed-Loop System treatment

SGLT2 inhibitor

Drug

SGLT-2 Inhibitor Treatment

MDI

Drug

Multiple Daily Injection Insulin treatment

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Attikon Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2025
First posted
Nov 21, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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