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

The Association Between Time in Range With Markers of Endothelail an Dcardiovascular Function in Patients With type1 Diabetes Mellitus and Minimed 780G

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06810700

Enrollment

Registered

2025-02-05

Start date

2025-02-15

Completion date

2025-09-15

Last updated

2025-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Brief summary

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.

Detailed 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.

Interventions

DEVICEMiniMed 780G

patients aged \>12 years old with T1DM who are on MiniMed 780G

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

12 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Endothelial glycocalyx	Baseline	The association between time in range and the thickness of endothelial glycocalyx
Pulse wave velocity	Baseline	The association between time in range and pulse wave velocity
Global longitudinal strain	Baseline	The association between time in range and global longitudinal strain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026