NCT04226846Unknown不适用
A Clinical Feasibility Study of the Bios Device for Continuous Glucose Monitoring in Subjects With Type 1 or Type 2 Diabetes Mellitus
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Comparison between Bios device readings and glucose values
研究概览
简要总结
The study is an open-label, prospective, within-subject comparison of the Bios device readings versus venous blood sample glucose readings, glucose readings from a Dexcom CGM and an SMBG device in subjects previously diagnosed with Type 1 or Type 2 diabetes mellitus.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is at least 18 years of age;
- •Subject has had a diagnosis of diabetes mellitus either Type I or Type II;
- •For insulin-using subjects only: subject will not inject insulin or wear an insulin pump insertion set within a 10 cm distance of any Bios device;
- •Subject able to wear multiple CGM devices simultaneously;
- •Subject is either a patient diagnosed with Type I diabetes mellitus currently wearing a Dexcom CGM device or a patient diagnosed with Type II diabetes mellitus who will agree to use a Dexcom CGM device during participation in the study. There are no restrictions on the model of the Dexcom CGM device.
- •Subject agrees to provide a log of medications (prescription and over-the-counter) and dietary supplements (e.g., vitamins) taken during the study period, including dosage;
- •Subject has a smart device that complies with the requirements listed in Attachment 1 of this protocol and is willing to download and run the GraphWear Patient application on their device;
- •Subject is able to read and understand the Informed Consent Form and has voluntarily provided written informed consent;
- •In the Principal Investigator's opinion, subject is able to be compliant with provisions laid out in this protocol.
排除标准
- •Subjects with any physical or behavioral disorder, which, in the opinion of the Principal Investigator, may interfere with the use of the device or compliance with the study protocol;
- •Subject has any of the following:
- •a skin condition that precludes wearing of the device;
- •a known allergy that precludes wearing of the device;
- •tattoos or other skin alterations that may interfere with device placement and/or operation;
- •History of substance abuse within 6 months of study start;
- •Use of any illicit drugs during the duration of the study period;
- •Marijuana use during the duration of the study period;
- •If female, subject is pregnant or nursing;
- •Subject is on active dialysis;
- •Subjects whom the Principal Investigator believes may not be an appropriate candidate for this device.
结局指标
主要结局
Comparison between Bios device readings and glucose values
时间窗: 2 weeks
The primary objective of this study is to compare the glucose measurements collected by the Bios device to glucose values measured with a blood glucose lab analyzer (e.g., YSI), glucose values obtained with a self-monitoring blood glucose device (SMBG) and readings from the Dexcom System in subjects previously diagnosed with Type 1 or Type 2 diabetes mellitus.
次要结局
未报告次要终点
研究者
研究点 (1)
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