EFFECT OF HYBRID CLOSED-LOOP SYSTEMS ON CARDIOVASCULAR MARKERS IN TYPE 1 DIABETES.
NCT ID: NCT07241702
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
100 participants
OBSERVATIONAL
2019-09-01
2025-12-01
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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HCL group
Patients will recieve hybrid closed loop system
HCLS
Hybrid Closed-Loop System treatment
SGLT-2i group
Patients will recieve SGLT-2i as add on treatment to multiple daily injections
SGLT2 inhibitor
SGLT-2 Inhibitor Treatment
MDI group
Patients will recieve intensification of MDI treatment.
MDI
Multiple Daily Injection Insulin treatment
Interventions
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HCLS
Hybrid Closed-Loop System treatment
SGLT2 inhibitor
SGLT-2 Inhibitor Treatment
MDI
Multiple Daily Injection Insulin treatment
Eligibility Criteria
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Inclusion Criteria
* history of type 1 diabetes with diabetes duration \> 5 years
* HbA1c ≥ 7% and ≤ 10%
* eGFR\> 60ml/min/1,73m2.
Exclusion Criteria
* severe hepatic impairment
* cardiovascular events within the recent three months
18 Years
80 Years
ALL
No
Sponsors
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Attikon Hospital
OTHER
Responsible Party
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VAIA LAMBADIARI
Professor of Internal Medicine-Endocrinology
Locations
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Attikon University General Hospital
Athens, , Greece
Countries
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Other Identifiers
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TYPE 1-HCLS
Identifier Type: -
Identifier Source: org_study_id
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