Adherence to Mediterranean Diet in Type 1 Diabetes Initiating Minimed 780G: Glucose Metrics vs Insulin Metrics, is There a Difference
Attikon Hospital
240 participants
Mar 1, 2025
OBSERVATIONAL
Conditions
Summary
In this observaltional study, 240 patients aged \>12 years old with T1DM who are on multiple daily injections or insulin pump and are scheduled to start using MiniMed 780G system will be included.We aim to compare patients' adherence to Mediterranean diet (MD) before and 12 weeks after initiation of MiniMed 780G and its association with CGM and insulin metrics, as well as anthropometric measurements, BMI, body composition, lipid levels, blood pressure and gut microbioma. Moreover, at baseline, at six and 12 months, markers of endothelial and cardiovascular function will be also assessed and associated with the use of Minimed 780G and the adherence to MD.
Eligibility
Inclusion Criteria6
- 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 Criteria2
- \. Diabetic Ketoacidosis in the 6 months prior to screening visits
- \-
Interventions
Minimed 780G HCL system (Metronic, Northridge, Ca, USA) is ConformitèEuropëenne(CE)-marked and includes additional functionality aiming to provide further protections from high glucose levels. When the system is used in Auto Mode automatically calculate the insulin dose based on information received from CGM. Signals are converted by the transmitter to sensor glucose values. Sensor values are then transmitted to the insulin pump. Sensor glucose and insulin delivery data are stored by the pump and may be uploaded. The HCL system can be programmed to automatically calculate insulin doses (both basal insulin and correction boluses) based on information received from CGM780G and the adherence to MD.
Locations(1)
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NCT06646107