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临床试验/NCT06848933
NCT06848933已完成不适用

Could the Advanced Hybrid Closed-Loop System Algorithm Provide Postprandial Normoglycemia After a High-Fat, High-Protein Meal

Ege University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年1月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
time spend in time in range (70-180 mg/dl) for postprandial 5 hours after the test meal

研究概览

简要总结

AHCL Systems Could Cover Postprandial Glycemic Response After High Fat and High Protein Meals

详细描述

On the 1st, 2nd and 3rd day of the study, a pediatric endocrinologist from the research team will evaluate the continuous glucose measurement system data and optimize the carbohydrate/insulin ratios. On the 4th and 7th days of the study, participants with blood sugar levels between 70-140 mg/dl according to the continuous glucose measurement system, which is a component of the hybrid closed-loop insulin infusion pump system, will consume the test meal consisting of Dr Oetker Ristorante Pizza Mista (340 grams) (92 g carbohydrate, 33 g protein, 41 g fat) at lunch, under the supervision of a dietician from the research team, by switching the pump to manual mode and entering the carbohydrate amount of the meal into the pump. This application will be repeated on the 11th and 14th days of the study while the participant's pump is in automatic mode. Participants will not be allowed to consume food or beverages other than water or exercise for 5 hours after the meal. Blood sugar monitoring will be done with a continuous glucose measurement system. The participant will leave the hospital 5 hours after the start of the meal to return to their normal life. Dr Oetker Ristorante Pizza Mista, which was selected as the test meal, was chosen because it is a macronutrient content that is consumed by young people between the ages of 9-18 and that is similar to the test meals in the world literature and accepted research reports reporting the effect of high-fat and high-protein meals on glycemic response in individuals with diabetes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
9 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Volunteering to participate in the study
  • •Not having a disease accompanying type 1 diabetes (celiac, cystic fibrosis, etc.)

排除标准

  • •- Not volunteering to participate in the study
  • •Using psychiatric medication or any medication that may cause obesity at the time of trial
  • •Having a disease accompanying type 1 diabetes (celiac, cystic fibrosis, etc.)

研究组 & 干预措施

Adolescents with type 1 diabetes on Medtronic Minimed 780G

Experimental

Each participant will consume the test meal in Medtronic Minimed 780Gmanual mode and Medtronic Minimed 780G in auto mode. Each participant will be in control of himself/herself

干预措施: Test meal (Other)

Adolescents with type 1 diabetes on Medtronic Minimed 780G

Experimental

Each participant will consume the test meal in Medtronic Minimed 780Gmanual mode and Medtronic Minimed 780G in auto mode. Each participant will be in control of himself/herself

干预措施: Each participant will consume the test meal when on Medtronic Minimed 780G and will consume test meal on Medtronic Minimed 780G on manual mode (Device)

Adolescents with type 1 diabetes on Medtronic Minimed 780G

Experimental

Each participant will consume the test meal in Medtronic Minimed 780Gmanual mode and Medtronic Minimed 780G in auto mode. Each participant will be in control of himself/herself

干预措施: Advanced hybrid closed loop system mode (Device)

结局指标

主要结局

time spend in time in range (70-180 mg/dl) for postprandial 5 hours after the test meal

时间窗: 1 month

Percentage of time when blood sugar is at 70-180 mg/dl for pst prandial 5 hours after the test meal

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasemin Atik Altinok

Dietician, PhD, Assoc Prof

Izmir Tinaztepe University

研究点 (1)

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