The Association Between Time in Range With Markers of Endothelial and Cardiovascular Function

Attikon University Hospital

Status: Not yet enrolling

Conditions: Type 1 Diabetes

Treatments: Device: MiniMed 780G

Study type: Observational

Funder types: Other

Identifiers

NCT06810700

TYPE 1DM_Time in range

Details and patient eligibility

About

In this observaltional study, 90 patients aged >12 years old with T1DM who are on MiniMed 780G system will be included.We aim to investigate the association between time in range (70-140mg/dl) and time in tight range (70-180mg/dl) with markers of endothelial and cardiovascular function.

Full description

In this observational study, 90 participants with T1D on MiniMed 780G system will be included. HbA1c, anthropometric measurements, CGM and Insulin Metrics will be assessed in all patients. Moreover, the investigators will assess:

1. the pulse wave velocity, the augmentation index and the central systolic blood pressure which are markers of arterial stiffness
2. the perfused boundary region of subglingulal vessels which is marker of endothelial function
3. the global longitudinal strain which is marker of myocardial function.

Enrollment: 90 estimated patients

Sex: All

Ages: 12 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Clinical diagnosis of type 1 diabetes >1 year prior to consent date. Diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required.
2. HbA1c < 12.5%
3. Age >7years at the initiation of the system
4. Multiple Daily Injections (Basal Bolus therapy) with Total daily insulin use of great than 8.0 units per day over a 1-week period
5. Clinically able to start the AHCL system
6. History of 3 clinic visits in the last year

Exclusion criteria

1. Diabetic Ketoacidosis in the 6 months prior to screening visits

Trial design

90 participants in 1 patient group

Type 1 Diabetes Mellitus

Description:

In this observaltional study, 90 patients aged \>12 years old with T1DM who are on MiniMed 780G system will be included.We aim to investigate the association between markers of endothelial and cardiovascular function with with CGM and insulin metrics, as well as anthropometric measurements, BM, lipid levels, blood pressure.

Treatment:

Device: MiniMed 780G