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临床试验/NCT03725657
NCT03725657已完成不适用

Using a Wrist-worn Accelerometer to Find a Correlation Between Exercise, Glycaemia and Insulin Dose in Type 1 Pediatric Patients, During a Camp: inCamp Study

University of Campania "Luigi Vanvitelli"1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年10月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Measure of steps through wrist accelerometer

研究概览

简要总结

Intense exercise is a major challenge to the management of type 1 diabetes. The management is even more difficult, during a camp, probably due to increased hypoglycemia maybe from increase of intensity of physical activity.

The investigators want to evaluate steps, energy expenditure, sleep time and glycemic control and insulin dosage, through use of a wrist accelerometer, in pediatric type 1 patients attending a camp. Finding a correlation between these parameters could be useful not only for educational purposes but also in the development of algorithms for artificial pancreas.

详细描述

Background and Aims Intense exercise is a major challenge to the management of type 1 diabetes. The management is even more difficult, during a camp, probably due to increased hypoglycemia maybe from increase of intensity of physical activity. Few studies confirm this hypothesis but none evaluated the correlation between steps, energy expenditure, sleep time and glycemic control and insulin dosage.

Methods and Materials 60 patients with type 1 diabetes, aged 10 to 12 years, in multiinjection insulin therapy observed for 21 days (one week of camp, one week before and one after it). Food program was the same both at home and during the camp. They checked glycemia almost 5 times a day. A wrist accelerometer was used to evaluate sleep, steps and energy expenditure.

All data were recorded in a daily diary.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
10 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • diabetes onset > 1 year, multiple injection insulin therapy

排除标准

  • Physical impossibility to movement, food allergy

结局指标

主要结局

Measure of steps through wrist accelerometer

时间窗: three weeks

number of steps

Measure of sleep expenditure through wrist accelerometer

时间窗: three weeks

hours of sleep

Measure of energy expenditure through wrist accelerometer

时间窗: three weeks

kcal

次要结局

  • Measure of glycemic control through glucometer(three weeks)
  • Measure of insulin dosage(three weeks)

研究者

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

Angela Zanfardino

Principal Investigator

University of Campania "Luigi Vanvitelli"

研究点 (1)

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