Type 1 DiabetesNCT07241702
EFFECT OF HYBRID CLOSED-LOOP SYSTEMS ON CARDIOVASCULAR MARKERS IN TYPE 1 DIABETES.
An observational study of Type 1 Diabetes, run by Attikon Hospital at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- HCLS, SGLT2 inhibitor and MDI
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 1 Sep 2019to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with poorly controlled type 1 diabetes
Who may be able to join
- age >18 years
- history of type 1 diabetes with diabetes duration > 5 years
- HbA1c ≥ 7% and ≤ 10%
- eGFR> 60ml/min/1,73m2.
Who cannot join
- history of malignancy within the last 5 years
- severe hepatic impairment
- cardiovascular events within the recent three months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- hybrid closed-loop systems (HCLS) or
- Sodium glucose co-transporter 2 inhibitors (SGLT-2i) added to MDI or
- 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.
Read the 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:
- 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).
- Conditions
- Type 1 Diabetes
- Being tested
- HCLS, SGLT2 inhibitor, MDI
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCLSDevice
Hybrid Closed-Loop System treatment
SGLT2 inhibitorDrug
SGLT-2 Inhibitor Treatment
MDIDrug
Multiple Daily Injection Insulin treatment
| Study group | Role | What they receive |
|---|---|---|
| HCL group | Patients will recieve hybrid closed loop system Receives: Device: HCLS | |
| SGLT-2i group | Patients will recieve SGLT-2i as add on treatment to multiple daily injections Receives: Drug: SGLT2 inhibitor | |
| MDI group | Patients will recieve intensification of MDI treatment. Receives: Drug: MDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Baseline, Six Months, Twelve months
Secondary outcomes (5)
Central Systolic Blood Pressure
The investigators will assess central systolic blood pressure as a marker of vascular function at baseline, at six and twelve months post-treatment
Measured: Baseline, Six Months, Twelve months
Central Diastolic Blood Pressure
The investigators will assess central diastolic blood pressure as a marker of vascular function at baseline, at six and twelve months post-treatment
Measured: Baseline, Six Months, Twelve months
Augmentation Index
The investigators will assess Augmentation Index as a marker of vascular function at baseline, at six and twelve months post-treatment
Measured: Baseline, Six Months, Twelve months
Flow mediated dilation
The investigators will assess Flow Mediated Dilation as a marker of endothelial function at baseline, at six and twelve months post-treatment
Measured: Baseline, Six Months, Twelve months
Coronary flow reserve
The investigators will assess Coronary flow reserve at baseline, at six and twelve months post-treatment
Measured: Baseline, Six Months, Twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Sep 2019
- Primary completion1 Sep 2022
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, VAIA LAMBADIARI, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241702
- Sponsor's protocol ID
- TYPE 1-HCLS
- Status last verified
- Oct 2026
- First submitted
- 17 Nov 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hybrid Closed-loop Systems on Markers of Endothelial, Myocardial and Vascular Function in Patients With Type 1 Diabetes.
- ClinicalTrials.gov ID
- NCT07241702
- Acronym / sponsor ID
- TYPE 1-HCLS
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- hybrid closed-loop systems (HCLS) or
- Sodium glucose co-transporter 2 inhibitors (SGLT-2i) added to MDI or
- 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.
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:
- 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HCL group | – | Device: HCLSPatients will recieve hybrid closed loop system |
| SGLT-2i group | – | Drug: SGLT2 inhibitorPatients will recieve SGLT-2i as add on treatment to multiple daily injections |
| MDI group | – | Drug: MDIPatients will recieve intensification of MDI treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with poorly controlled type 1 diabetes
Key inclusion criteria (4 listed)
- age >18 years
- history of type 1 diabetes with diabetes duration > 5 years
- HbA1c ≥ 7% and ≤ 10%
- eGFR> 60ml/min/1,73m2.
Key exclusion criteria (3 listed)
- history of malignancy within the last 5 years
- severe hepatic impairment
- cardiovascular events within the recent three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HCLSHybrid Closed-Loop System treatment | Device | HCL group |
| SGLT2 inhibitorSGLT-2 Inhibitor Treatment | Drug | SGLT-2i group |
| MDIMultiple Daily Injection Insulin treatment | Drug | MDI group |
Primary outcome
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
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
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
5 secondary outcomes
Central Systolic Blood Pressure
Time frame: Baseline, Six Months, Twelve months
Central Diastolic Blood Pressure
Time frame: Baseline, Six Months, Twelve months
Augmentation Index
Time frame: Baseline, Six Months, Twelve months
Flow mediated dilation
Time frame: Baseline, Six Months, Twelve months
Coronary flow reserve
Time frame: Baseline, Six Months, Twelve months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Attikon Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse Wave Velocity (time frame: Baseline, Six Months, Twelve months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.