Type 1 Diabetes
Conditions
Brief summary
In this cross-sectioanl study, 90 patients aged \>12 years old with T1DM who are on MiniMed 780G system will be included.The investigators aim to assesse the association of patients' adherence to Mediterranean diet (MD) with CGM and insulin metrics, as well as anthropometric measurements, BMI, lipid levels and blood pressure.Moreover, markers of endothelial, cardiovascular and liver function will be also assessed and associated with the use of Minimed 780G and the adherence to MD.
Detailed description
This cross-sectional study will include 90 participants, children adolescents and young adults (12\> years old) with T1D that are on MiniMed 780G system. Participants will be evaluated for adherence to Meditteranean Diet (MD) with PREDIMED questionnaire. HbA1c, CGM and Insulin Metrics, anthropometric measurements, blood pressure and lipid leves will be aso evalutaed. Markers of endothelial cardiovascular and liver function will also be assessed.
Interventions
DEVICEMinimed 780G
patients aged \>12 years old with T1DM who are on MiniMed 780G
Sponsors
Attikon Hospital
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
12 Years to 80 Years
Healthy volunteers
No
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. Patients with Minimed 780G 5. History of 3 clinic visits in the last year
Exclusion criteria
Diabetic Ketoacidosis in the 6 months prior to screening visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in Range | Baseline | Assessment of time in range |
| Time below range | Baseline | Assessment of time below range |
| Time above range | Baseline | Assessment of time above range |
| Basal Insulin dose | Baseline | Assessment of basal insulin doses |
| Correction Insulin dose | Baseline | Assessment of correction insulin dose |
| Pulse wave velocity | Baseline | Assessment of pulse wave velocity |
| Endothelial glycocalyx | Baseline | Assessemnet of the thickness of endothelial glycocalyx |
| Global longitudinal strain | Baseline | Assessment of global longitudinal strain. |
| E score | Baseline | Assessement of E score and CAP score. |
| Assessment of CAP score | Baseline | CAP score |
| MED diet | Baseline | Assesment of Adherence to MED diet |
| Fat mass | Baseline | Assessment of fat mass |
| Lean Mass | Baseline | Assessment of lean mass |
Countries
Greece
Contacts
PRINCIPAL_INVESTIGATORVaia Lambadiari
Attikon General University Hospital
Outcome results
None listed