The Association Between Time in Range With Markers of Endothelial and Cardiovascular Function
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MiniMed 780G.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes. Basic parameters: 12 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Association Between Time in Range With Markers of Endothelail an Dcardiovascular Function in Patients With type1 Diabetes Mellitus and Minimed 780G
Overview
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
- Device MiniMed 780G
patients aged \>12 years old with T1DM who are on MiniMed 780G
Primary outcome measures
- Endothelial glycocalyx [Time frame: Baseline]
- Pulse wave velocity [Time frame: Baseline]
- Global longitudinal strain [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- 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.
- HbA1c < 12.5%
- Age >7years at the initiation of the system
- Multiple Daily Injections (Basal Bolus therapy) with Total daily insulin use of great than 8.0 units per day over a 1-week period
- Clinically able to start the AHCL system
- History of 3 clinic visits in the last year
Exclusion criteria
1\. Diabetic Ketoacidosis in the 6 months prior to screening visits
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06810700 · TYPE 1DM_Time in range