Evaluation of SCOUT DS Device in the Diagnosis of Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 409
- 试验地点
- 1
- 主要终点
- Comparison of SCOUT DS to Random Capillary Glucose
研究概览
简要总结
The primary objective is to identify compare SCOUT DS to random capillary glucose for identification of at-risk subjects with dysglycemia defined by hemoglobin A1C ≥ 6.0%.
详细描述
The study will complete up to 400 subjects at the clinical site to evaluate the precision and accuracy of SCOUT DS and random capillary glucose for detecting pre-diabetes and undiagnosed type 2 diabetes in subjects at risk but not having a pre-existing diagnosis of type 2 diabetes. A point of care A1c measurement will serve as the reference method for defining pre-diabetes (6.0% ≤ A1c ≤ 6.4%) and diabetes (A1c ≥ 6.5%).
The study will require one visit by each subject to the clinical site. The visit does not require fasting and can be done any time of day. The study (not including the IRB process and recruiting) is expected to last 6 months.
The target cohort for comprises persons at risk for pre-diabetes and/or type 2 diabetes.
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
- 是
入选标准
- •Age greater than or equal to 45 years
- •Age 18 to 44 years and with one or more of the following risk factors:
- •BMI > 25 kg/m²
- •Elevated waist circumference, > 35 inches for women and >40 inches for men
- •Habitually physically inactive (does not exercise regularly)
- •Has a first-degree relative with diabetes
- •Ethnicity with elevated risk for type 2 diabetes
- •Has delivered a baby weighing > 9 lb or diagnosed with gestational diabetes
- •Hypertension (≥130/≥ 85 mmHg) or being treated for hypertension
- •HDL cholesterol level < 35 mg/dL and/or a fasting triglyceride level ≥ 250 mg/dL or being treated for dyslipidemia with medication
- •Has been previously diagnosed with Polycystic Ovary Syndrome (PCOS)
- •Had impaired glucose tolerance or impaired fasting glucose on previous testing within the last 3 yrs
- •Conditions associated with insulin resistance such as acanthosis nigricans
- •History of vascular disease including heart attack, stroke, angina, coronary heart disease, atherosclerosis, congestive heart failure or peripheral arterial disease
排除标准
- •• Under 18 years of age
- •Receiving investigational treatments in the past 14 days
- •Psychosocial issues that interfere with an ability to follow study procedures
- •Conditions that cause secondary diabetes including Cushing's syndrome, acromegaly, hemochromatosis, pancreatitis, or cystic fibrosis
- •Diagnosed with any type of diabetes, including type 1 or 2
- •Taking glucose lowering medications with the exception of metformin
- •Known to be pregnant
- •Receiving dialysis or having known renal compromise
- •Scars, tattoos, rashes or other disruption/discoloration on the left volar forearm.
- •Recent (within past month) or current oral steroid therapy or topical steroids applied to the left forearm; inhaled steroid therapy is not excluded
- •Current chemotherapy, or chemotherapy within the past 12 months
- •Receiving medications that fluoresce*
- •Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)
结局指标
主要结局
Comparison of SCOUT DS to Random Capillary Glucose
时间窗: Up to 6 months
A point of care A1c measurement will serve as the reference method for defining pre-diabetes (6.0% ≤ A1c ≤ 6.4%) and diabetes (A1c ≥ 6.5%). The study will require one visit by each subject to the clinical site. The visit does not require fasting and can be done any time of day. The study (not including the IRB process and recruiting) is expected to last 6 months. The target cohort for comprises persons at risk for pre-diabetes and/or type 2 diabetes.
次要结局
未报告次要终点