Adherence to Mediterranean Diet in Type 1 Diabetes Initiating Minimed 780G: Glucose Metrics vs Insulin Metrics, is There a Difference
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Changes in Hba1c
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •1. Diabetic Ketoacidosis in the 6 months prior to screening visits
结局指标
主要结局
Changes in Hba1c
时间窗: Baseline, 3 months
Differences in HbA1c at baseline and 3 months after the initiation of MiniMed 780G
Changes in TIR
时间窗: Baseline, 3 months
Changes in TIR at baseline and 3 months after the initiation of MiniMed 780G
Changes in TBR
时间窗: Baseline, 3 months
Changes in TBR at baseline and 3 months after the initiation of MiniMed 780G
Changes in TAR
时间窗: Baseline, 3 months
Changes in TAR at baseline and 3 months after the initiaton of MiniMed 780G
Changes in bolus doses
时间窗: Baseline, 3 months
Changes in bolus dosed at baseline and 3 months after the initiation of MiniMed 780G
Changes in basal doses
时间窗: Baseline, 3 months
Changes in basal doses at baseline and 3 months after the initiation of MiniMed 780G
Changes in autocorrection doses
时间窗: Baseline, 3 months
Changes in autocorrection doses between baseline and 3 months after the initiation of MiniMed 780G:
次要结局
- Changes in pulse wave velocity(m/s)(Baseline, 6 months, 12 months)
- Changes in endothelial glycocalyx thickness (μm)(Baseline, 6 months, 12 months)
- Changes in global longidutinal strain (%)(Baseline, 6 months, 12 months)
- Changes in CAP (dB/m)(Baseline, 6 months, 12 months)
- Changes in gut microbioma(Baseline,3 months)
- Changes in coronary flow reserve(Baseline, 6 months, 12 months)
- Changes in central aortic blood pressure (mmHg)(Baseline, 6 months, 12 months)
- Changes in Ε score (Kpa)(Baseline, 6 months, 12 months)
研究者
VAIA LAMBADIARI
Professor of Internal Medicine-Endocrinology
Attikon Hospital