Evaluation of a Percutaneous Optical Fibre Glucose Sensor (FiberSense) Across the Glycemic Range With Rapid Glucose Excursions Using the Glucose Clamp
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Overall performance of the FiberSense device as compared with YSI
研究概览
简要总结
This is a single center prospective study. The purpose of this study is to assess the performance of FiberSense system across the glucose measurement ranges (from hypoglycemia to hyperglycemia) as compared with a gold standard reference laboratory method (YSI glucose) in healthy volunteers.
详细描述
The FiberSense system is intended to be used by diabetic patients in a home use setting as a CGM system using the interstitial fluid (ISF) glucose as an indicator of blood glucose levels.The purpose of this study is to assess the performance of FiberSense system across the glucose measurement ranges (from hypoglycemia to hyperglycemia) as compared with a gold standard reference laboratory method (YSI glucose) in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female age ≥ 18 years old.
- •Nondiabetic subjects with normal fasting plasma glucose and HbA1c (≤5.6%)
- •Women who are not pregnant, lactating or planning a pregnancy during their participation in the clinical study.
- •Willingness, ability and commitment to comply with the testing, procedure and follow-up outlined in this protocol including (but not limited to) frequency of clinic visits and use of pre-specified glucose monitoring devices.
- •Willingness to abstain from bathing and swimming during their participation in the measurement phase.
- •In the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude the patient from being a good study candidate.
- •Written informed consent to participate in the study provided by the patient.
排除标准
- •Currently pregnant, as demonstrated by a positive pregnancy test at screening and on day of first sensor insertion
- •Impaired hepatic function measured as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ three times the upper reference limit.
- •Impaired renal function measured as serum creatinine > 1.2 times above the upper limit of normal.
- •Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
- •Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
- •Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device.
- •Extensive skin changes/diseases that preclude wearing the required number of devices on normal skin at the proposed application sites (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis).
- •Have a known allergy to medical-grade adhesives, or known hypersensitivity to any of the products used in the study.
- •Known current or recent alcohol or drug abuse
- •Blood donation of more than 500 ml within the last three months
- •Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection.
- •History of epilepsy
- •History of cardiac arrhythmias
- •Clinically significant abnormality on ECG at screening
- •An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).
研究组 & 干预措施
Device: FiberSense system
10 subjects will wear 2 FiberSense system in abdomen and upper arm respectively and Dexcom G4 Platinum CGM sensor for 1 day.
干预措施: FiberSense system (Device)
Extension Phase
2 subjects will extend the wearing of the sensors up to 14 days (2 FiberSense systems to Day 14 and Dexcom sensor to Day 7±1) after the glucose clamp study.
干预措施: FiberSense system (Device)
结局指标
主要结局
Overall performance of the FiberSense device as compared with YSI
时间窗: 1 day
Proportion of FiberSense readings within ≤15% of the reference (YSI) reading for blood glucose levels \>100 mg/dl (5.55 mmol/l), and the proportion of FiberSense readings within ≤15 mg/dl (0.83 mmol/l) of the YSI reading for blood glucose levels ≤100 mg/dl.
次要结局
- Precision of FiberSense system readings: Precision Absolute Relative Differences with comparison of FiberSense system locations (inter and intra)(1 day)
- Percentage of readings that are within 15% of the YSI values(1 day)
- Percentage of readings that are within 40% of the YSI values(1 day)
- Median Absolute Relative Differences in FiberSense measured glucose from the reference laboratory method (YSI)(1 day)
- Accuracy of glucose rate of change measured by FiberSense sensor compared to glucose rate of change measured using the reference laboratory method (YSI)(1 day)
- Percentage of readings that are greater than 40% of the YSI values(1 day)
- Mean Absolute Relative Differences in FiberSense measured glucose from the reference laboratory method (YSI)(1 day)
- Mean relative differences in FiberSense measured glucose from the reference laboratory standard (YSI)(1 day)
- Lag time between FiberSense readings and reference laboratory method (YSI) results during induced glucose excursions(1 day)
- Median relative differences in FiberSense measured glucose from the reference laboratory standard (YSI)(1 day)
- Percentage of readings that are within 30% of the YSI values(1 day)
- Percentage of readings that are within 20% of the YSI values(1 day)
- Adverse Event Reporting(14 days)