Performance Characteristics of Non-invasive Glucose Monitoring Device Prototypes
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Validation of predictive algorithms for determining blood glucose levels
研究概览
简要总结
This clinical study has been launched to collect spectral raman data paired with validated glucose reference values in private homes of subjects
详细描述
Subjects will collect either 8 or 44 daily optical raman readings paired with either 8 capillary Blood Glucose comparator or 8 capillary Blood Glucose comparator plus 44 readings using a flash glucose monitoring system in own home with maintaining usual routines. Subjects will either collect data for 5 days during a 10 days period or collect data for 90 days during a 40 days period or collect data for 90 days during 6 months period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- 否
入选标准
- •Male and female subjects 18 years of age or older
- •Diabetic patients (all types)
- •Skin phototype 1-4
排除标准
- •For female participants: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration
- •For female participants: Breastfeeding
- •Subjects not able to understand and read Danish
- •In Investigator's opinion, subject is not able to follow instructions as specified in the protocol
- •Participants not able to hold hand/arm steadily (including tremors and Parkinson's Disease)
- •Diagnosed with reduced circulation
- •Extensive skin changes, tattoos or diseases on probe application site
- •Known allergy to medical grade alcohol
- •Known allergy to adhesives, applicable to subjects in RSP-16-01
- •Systemic or topical administration of glucocorticoids for the past 7 days and under investigation
- •Participants undergoing dialysis treatment
- •Medical history or any condition that may, in the opinion of the Investigator, compromise the subject's ability to participate
- •Concomitant medical condition which could present a risk to the safety or welfare of the subject or study staff.
- •Participants currently enrolled in another study
结局指标
主要结局
Validation of predictive algorithms for determining blood glucose levels
时间窗: 3 years
Performance of predictive models will be evaluated using the consensus error grid.
Generation of predictive algorithms for determining blood glucose levels
时间窗: 3 years
Collected spectral raman data will found the development of predictive algorithms for glucose determination.
次要结局
未报告次要终点