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临床试验/NCT03368586
NCT03368586已完成不适用

Accuracy, Satisfaction and Usability of a Flash Glucose Monitoring System Among Children and Adolescents Attending a Diabetes Camp

University of Lausanne Hospitals0 个研究点目标入组 70 人开始时间: 2016年7月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
主要终点
FGM accuracy

研究概览

简要总结

The aim of this study was to assess accuracy, satisfaction and usability of the FGM among children and adolescents with T1DM. The primary outcome was to assess the accuracy of the FGM system. Secondary outcomes included satisfaction and usability of the device as well as assessment of sensor-related issues.

详细描述

The aim of this study was to assess the accuracy, satisfaction and usability of a Flash Glucose Monitoring system (FGM) in children and adolescents with type 1 diabetes mellitus (T1DM) and attending a 1-week diabetes summer camp, supervised by a multidisciplinary team of health care providers. The camp comprised a structured daily routine with five fixed meals: breakfast, lunch, afternoon snack, dinner and evening snack. Capillary blood glucose (BG) values were measured in parallel with unmasked Flash Glucose measurements (FGM) using the FGM reader's built-in glucometer at breakfast, lunch and dinner. Additional measurements were taken before snacks, between the meals or overnight and BG was measured only in cases of low (<4.0 mmol/L) or high (>15.0 mmol/L) FGM values or when symptoms were discordant with sensor readings. Sensor-related issues were documented and a questionnaire assessing satisfaction and usability of the FGM was completed by patients and caregivers at study completion.

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
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Type 1 diabetes mellitus, children and adolescents participating at the diabetes summer camp.

排除标准

  • •Acute health condition (infectious disease), known allergy to medical adhesives or with a skin condition (e.g. atopic dermatitis)).

结局指标

主要结局

FGM accuracy

时间窗: through study completion, 1 week

Accuracy of FGM values versus reference blood glucose values (Consensus Error Grid (CEG) analysis and calculation of the Mean Absolute Relative Difference (MARD))

次要结局

  • Participants satisfaction with the FGM system(At last camp day)
  • Sensor related-issues(Through study completion, 1 week)
  • Caregivers satisfaction with the FGM system(At last camp day)

研究者

发起方
University of Lausanne Hospitals
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Hauschild

Dr.

University of Lausanne Hospitals

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