Evaluating Non-Invasive Measurement of Sweat Glucose of Patients With Diabetes - The ENGAGE Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Glucose measurements
研究概览
简要总结
This pilot clinical trial will explore the accuracy and acceptability of a non-invasive, wearable glucose sensor in patients living with DM. This study will compare needleless glucose sensor readings from sweat with glucometer measurements from patients with any type of diabetes at fasting, and after a meal.
详细描述
There is an unmet need for a non-invasive glucose monitoring device. UCSD nanoengineers developed a flexible, ultra-thin sensor adherent to the skin, similar to a temporary tattoo. Sweat glucose correlates with blood glucose. This proposed study would be the first to examine this needle-free glucose sensor to measure glucose in endogenous sweat in individuals with DM, and would serve as the basis for future development of a continuous, non-invasive sensor. The investigators hypothesize that compared with a glucometer, a tattoo sensor can accurately measure sweat glucose in patients with DM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with an existing diagnosis of diabetes mellitus, of any type, defined as having a fasting plasma glucose (FPG) > 126 mg/dL, or hemoglobin A1c (HbA1c) > 6.5%.
- •Ability to provide informed consent for participation.
排除标准
- •Individuals who do not have diabetes.
- •Those who have an allergy to pilocarpine.
- •Frequent episodes of low blood sugar (hypoglycemia), have no warning symptoms of hypoglycemia (hypoglycemia unawareness), or are at high risk of having hypoglycemia.
- •If taking any of the following medications: any beta-blockers (including atenolol, carvedilol, metoprolol, and propanolol), chlorthalidone, hydrochlorothiazide, oxybutynin, and tiotropium.
- •Individuals who have the following conditions, for which it is not safe to take pilocarpine, including:
- •Known or suspected gallstones or gallbladder disease
- •Kidney stones
- •Conditions that affect your thinking and/or memory, including Parkinson's disease and Alzheimer's disease
- •Chronic obstructive pulmonary disease (COPD)
- •Irritable Bowel Syndrome
- •Pregnancy - a pregnancy test will be obtained for each woman of child-bearing age.
研究组 & 干预措施
Patients with Diabetes
All participants will receive a minimum of 2 doses of pilocarpine 0.1 mL gel, applied to the skin via the glucose sensor to induce sweat. Glucose will be measured with both an adhesive (needle-free) glucose sensor and a glucometer, at fasting, and time points ranging from 15 to 200 minutes after consuming a standardized meal. There are no other interventions.
干预措施: Adhesive glucose sensor (Device)
Patients with Diabetes
All participants will receive a minimum of 2 doses of pilocarpine 0.1 mL gel, applied to the skin via the glucose sensor to induce sweat. Glucose will be measured with both an adhesive (needle-free) glucose sensor and a glucometer, at fasting, and time points ranging from 15 to 200 minutes after consuming a standardized meal. There are no other interventions.
干预措施: Pilocarpine (Drug)
结局指标
主要结局
Glucose measurements
时间窗: Fasting, and time points ranging from 15 to 200 minutes after consuming a standardized meal. Participants can complete this study in 1 or 2 visits. The study team anticipates to complete this clinical trial in approximately 1 year.
Comparing glucose readings from the sensor with those from a glucometer
次要结局
- Acceptability of sensor(The investigators will collect this data at the completion of the study, after the fasting and post-meal glucose readings (at time points ranging from 15 to 200 minutes) are collected.)
研究者
Edward Chao
Associate Clinical Professor
University of California, San Diego