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

NCT07241702 | Active Not Recruiting

• 1 other identifier: TYPE 1-HCLS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 1.hybrid closed-loop systems (HCLS) or
2. 2.Sodium glucose co-transporter 2 inhibitors (SGLT-2i) added to MDI or
3. 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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (3)

• Pulse Wave Velocity

  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

  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

  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 Outcomes (5)

• Central Systolic Blood Pressure

  Baseline, Six Months, Twelve months

• Central Diastolic Blood Pressure

  Baseline, Six Months, Twelve months

• Augmentation Index

  Baseline, Six Months, Twelve months

• Flow mediated dilation

  Baseline, Six Months, Twelve months

• Coronary flow reserve

  Baseline, Six Months, Twelve months

Study Arms (3)

HCL group

Patients will recieve hybrid closed loop system

Device: HCLS

SGLT-2i group

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

Drug: SGLT2 inhibitor

MDI group

Patients will recieve intensification of MDI treatment.

Drug: MDI

Interventions

HCLS DEVICE

Hybrid Closed-Loop System treatment

HCL group

SGLT2 inhibitor DRUG

SGLT-2 Inhibitor Treatment

SGLT-2i group

MDI DRUG

Multiple Daily Injection Insulin treatment

MDI group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with poorly controlled type 1 diabetes

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Attikon Hospital: lead

Study Sites (1)

Attikon University General Hospital

Athens, 12462, Greece

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine-Endocrinology

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: September 1, 2019
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

GR (1)