Идёт набор NCT06646107

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

— Наблюдательное Type1diabetes

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: MInimed 780G.
Кому может быть актуально: Состояния в реестре: Type1diabetes. Базовые параметры: 12 лет — 80 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Греция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

Устройство 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

Первичные конечные точки

Changes in Hba1c [Срок оценки: Baseline, 3 months]
Changes in TIR [Срок оценки: Baseline, 3 months]
Changes in TBR [Срок оценки: Baseline, 3 months]
Changes in TAR [Срок оценки: Baseline, 3 months]
Changes in bolus doses [Срок оценки: Baseline, 3 months]
Changes in basal doses [Срок оценки: Baseline, 3 months]
Changes in autocorrection doses [Срок оценки: Baseline, 3 months]

Вторичные конечные точки (8)

Changes in pulse wave velocity(m/s) [Срок оценки: Baseline, 6 months, 12 months]
Changes in endothelial glycocalyx thickness (μm) [Срок оценки: Baseline, 6 months, 12 months]
Changes in global longidutinal strain (%) [Срок оценки: Baseline, 6 months, 12 months]
Changes in CAP (dB/m) [Срок оценки: Baseline, 6 months, 12 months]
Changes in gut microbioma [Срок оценки: Baseline,3 months]
Changes in coronary flow reserve [Срок оценки: Baseline, 6 months, 12 months]
Changes in central aortic blood pressure (mmHg) [Срок оценки: Baseline, 6 months, 12 months]
Changes in Ε score (Kpa) [Срок оценки: Baseline, 6 months, 12 months]

Критерии участия

Критерии включения

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