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Recruiting NCT06646107

Adherence to Mediterranean Diet in Type 1 Diabetes Initiating Minimed 780G: Glucose Metrics vs Insulin Metrics, is There a Difference

— Observational Type1diabetes

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: Type1diabetes. 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
Greece
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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Overview

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.

Detailed description

This observational study will include 240 participants (80 participants per country) from IGI region (Italy, Greece and Israel), children adolescents and young adults (12\> years old) with T1D that are on multiple daily injections or insulin pump and are scheduled to start using MiniMed 780G system. After a 7-day run-in period, participants will be evaluated with food intake log and adherence to Meditteranean Diet (MD) with PREDIMED questionnaire. One hour session on MD and healthy impact on Diabetes will be provided to all participants and will be assigned to initiate MiniMed 780G and followed for 12 weeks. HbA1c, CGM and Insulin Metrics, anthropometric measurements, body composition, blood pressure and lipid leves as well a gut microbioma will be performed at baseline and 12 weeks, after MiniMed 780G initiation. A 7-day food diary logbook will be collected to identify the amount and type of the food at baseline and at the end of the study. At baseline, at 6 and at 12 months, markers of endothelial and cardiovascular function will also be assessed. An extension phase will include additional 3 and 6, which concludes one year of follow-up.

Interventions

  • Device MInimed 780G
    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 an

Primary outcome measures

  • Changes in Hba1c [Time frame: Baseline, 3 months]
  • Changes in TIR [Time frame: Baseline, 3 months]
  • Changes in TBR [Time frame: Baseline, 3 months]
  • Changes in TAR [Time frame: Baseline, 3 months]
  • Changes in bolus doses [Time frame: Baseline, 3 months]
  • Changes in basal doses [Time frame: Baseline, 3 months]
  • Changes in autocorrection doses [Time frame: Baseline, 3 months]
Secondary outcome measures (8)
  • Changes in pulse wave velocity(m/s) [Time frame: Baseline, 6 months, 12 months]
  • Changes in endothelial glycocalyx thickness (μm) [Time frame: Baseline, 6 months, 12 months]
  • Changes in global longidutinal strain (%) [Time frame: Baseline, 6 months, 12 months]
  • Changes in CAP (dB/m) [Time frame: Baseline, 6 months, 12 months]
  • Changes in gut microbioma [Time frame: Baseline,3 months]
  • Changes in coronary flow reserve [Time frame: Baseline, 6 months, 12 months]
  • Changes in central aortic blood pressure (mmHg) [Time frame: Baseline, 6 months, 12 months]
  • Changes in Ε score (Kpa) [Time frame: Baseline, 6 months, 12 months]

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

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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

Greece · 1 center
  • Attikon University General Hospital — Chaïdári

Identifiers

NCT: NCT06646107 · MED_TYPE 1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗