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临床试验/NCT06246578
NCT06246578暂停不适用

Concordance of Hypoglycemia Measurement in People With Type 1 Diabetes, With Simultaneous Use of Two Devices for Continuous Glucose Measurement: Abbott Freestyle Libre 2 and Dexcom G7

Central Jutland Regional Hospital2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2024年1月19日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
14
试验地点
2
主要终点
Difference between paired blood glucose values and simultaneous Dexcom and Libre glucose values

研究概览

简要总结

The aim of this study is to compare two frequently used sensors for continuous glucose monitoring (CGM); Freestyle Libre and Dexcom G 7. More precisely, the investigators want to investigate if there is any difference in the hypoglycemic range for these two devices.

详细描述

The investigators are including adults with type 1 diabetes who already are using a Dexcom G 7, in their diabetes treatment. Simultaneously with their Dexcom G7, the participants will get the Libre 2 sensor attached, and are to wear this for a period of 14 days. The Libre sensor is a Freetsyle Libre 2. Glucose data are compared for paired values within a time interval of 5 min or less. In this way the investigators have access to nearly simultaneous glucose values from two different CGM's. In addition, the participants are given a Contour Next One, and are asked to measure their blood glukose with fingerprick if their Dexcom registers a glucose value < 5 mmol/l.

By this project, we hope to gain more precise information about the two most widely distributed CGMs, and their function in the hypoglycemic area. This, can have impact on healthcare professionals' future therapeutic instructions, regarding the use of insulin adjustment and carbohydrate compensation.

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

性别
All
接受健康志愿者

入选标准

  • Type 1 diabetes Using Dexcom G 7 -

排除标准

  • Do not want to participate

结局指标

主要结局

Difference between paired blood glucose values and simultaneous Dexcom and Libre glucose values

时间窗: 5 minutes or less between the glucose values compared

Difference between paired blood glucose values and simultaneous CGM values for Dexcom and Libre for Dexcom values \< 5 mmol/l

Difference between paired Dexcom and Libre glucose values

时间窗: 5 minutes or less between the glucose values compared

Difference between paired simultaneous CGM value for Dexcom and Libre for all measured glucose values.

次要结局

未报告次要终点

研究者

发起方
Central Jutland Regional Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Klavs Würgler Hansen

Professor

Central Jutland Regional Hospital

研究点 (2)

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