Clinical trial NCT06646107: Adherence to Mediterranean Diet in Type 1 Diabetes Initiating Minimed 780G: Glucose Metrics vs Insulin Metrics, is There a Difference
Official title: Adherence to Mediterranean Diet in Type 1 Diabetes Initiating Minimed 780G: Glucose Metrics vs Insulin Metrics, is There a Difference
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Type1diabetes
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 240
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

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.

Eligibility criteria: 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

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Primary outcomes:
measure: Changes in Hba1c
timeFrame: Baseline, 3 months
measure: Changes in TIR
timeFrame: Baseline, 3 months
measure: Changes in TBR
timeFrame: Baseline, 3 months
measure: Changes in TAR
timeFrame: Baseline, 3 months
measure: Changes in bolus doses
timeFrame: Baseline, 3 months
measure: Changes in basal doses
timeFrame: Baseline, 3 months
measure: Changes in autocorrection doses
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Changes in pulse wave velocity(m/s)
timeFrame: Baseline, 6 months, 12 months
measure: Changes in endothelial glycocalyx thickness (μm)
timeFrame: Baseline, 6 months, 12 months
measure: Changes in global longidutinal strain (%)
timeFrame: Baseline, 6 months, 12 months
measure: Changes in CAP (dB/m)
timeFrame: Baseline, 6 months, 12 months
measure: Changes in gut microbioma
timeFrame: Baseline,3 months
measure: Changes in coronary flow reserve
timeFrame: Baseline, 6 months, 12 months
measure: Changes in central aortic blood pressure (mmHg)
timeFrame: Baseline, 6 months, 12 months
measure: Changes in Ε score (Kpa)
timeFrame: Baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Chaidari
country: Greece
facility: Attikon University General Hospital
Study officials:
References: