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临床试验/NCT02338817
NCT02338817终止不适用

Clinical Evaluation of a Non-Invasive Hypoglycemia Detector in a Glycogen Storage Disease Population

University of Florida1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2015年12月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
9
试验地点
1
主要终点
Blood Glucose

研究概览

简要总结

Glycogen storage disease (GSD) patients frequently experience periods of hypoglycemia, putting them at risk for several complications, such as hepatomegaly, adenomas, and cirrhosis. As of now, glycogen storage disease patients are limited to using finger stick glucose meters to monitor their glycemia at home. Diabetes Sentry, a non-invasive hypoglycemia detector designed like a watch, has been available for diabetic patients to non-invasively alert for hypoglycemia, but has never been tested in a GSD population. The investigators propose to test the accuracy of the Diabetes Sentry on patients with GSD types 0, I, III, VI, and IX, by measuring their metabolic markers every two hours, as well as whenever the device alerts for hypoglycemia. If accurate, it could be a useful tool for GSD patients in managing hypoglycemia, both clinically and at home.

详细描述

As a participant the following will take place:

The Diabetes Sentry device, which is non-invasive and is worn on the wrist will be used while an inpatient at the University of Florida Health & Shands Hospital. Participants will be monitored for the duration of the observational period on the unit, an expected average will be 24 hours. The device is designed to alarm during periods of perspiration and drops in body temperature. When this occurs, a blood draw will be taken to test for glucose, lactate, and ketone values at those times if there is not an already scheduled clinical care blood draw for normal clinical care.

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
— 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed and clinically treated at the University of Florida with any of the glycogen storage diseases I, III, VI, IX, 0 will be asked to participate in this study.

排除标准

  • Patients not clinically treated at the University of Florida.

结局指标

主要结局

Blood Glucose

时间窗: At time of alarm (Average of 24 hours)

glucose level at time of device alarm

Blood Lactate

时间窗: At time of alarm (Average of 24 hours)

lactate level at time of device alarm

Blood Ketones

时间窗: At time of alarm (Average of 24 hours)

ketone level at time of device alarm

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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