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NCT07241702
EFFECT OF HYBRID CLOSED-LOOP SYSTEMS ON CARDIOVASCULAR MARKERS IN TYPE 1 DIABETES.
Conditions: Type 1 Diabetes
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Enrollment: 100
Sponsor: Attikon Hospital
Location: Attikon University General Hospital Athens
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. 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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07241702). StuddyBuddy aggregates publicly available trial information.
