Calibration of a Non-invasive Glucose Measurement Device and Assessment of Its Performance in the Hypoglycemic Range in Patients With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 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 and reference measurements to establish and validate a calibration model for the device during daily glycemic fluctuations and evaluate analytical performance of device in the hypoglycemic range. The study is a combined home-based and in-clinic study where subjects will attend the clinic two times.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects between 18 and 40 years of age.
- •Diagnosed with type 1 diabetes mellitus.
- •Uses an insulin pen or pump.
- •Hb1Ac > 55 mmol/mol at baseline visit.
- •Skin phototype 1-4 according to Fitzpatrick skin tone scale.
- •Willing to perform a minimum of 8 finger sticks per day during the study for the home-based study and approximately 16 finger sticks for the in-clinic study days.
- •Willing to have a peripheral venous catheter inserted.
- •Willing to provide written signed and dated informed consent.
排除标准
- •Breastfeeding, pregnant, attempting to conceive or not willing and able to practice birth control according to approved contraceptives from NCA during the study execution (applicable to female subjects only).
- •Subjects not able to understand and read Danish.
- •Inability to comply with the study procedures as described by the study protocol, according to the opinion of the investigator.
- •Subject is not able to hold hand/arm steadily (including tremors and Parkinson's Disease).
- •Reduced circulation in hand. "Allen's test" is used for assessing hand circulation to evaluate occurrence of reduced blood.
- •Extensive skin changes, tattoos or diseases on probe application site (thenar) that could interfere with the accuracy of the interstitial glucose measurements.
- •Known allergy to medical grade alcohol.
- •Having active cancer treatment and/or use tetracyclines and other medication / topical agents known to increase photosensitivity in skin.
- •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.
- •Diagnosed with cardiovascular diseases.
- •Subjects currently enrolled in another study.
- •Radiotherapy for the past six months.
结局指标
主要结局
Validation of predictive algorithms for determining blood glucose levels
时间窗: 12 months
Performance of predictive models will be evaluated using the consensus error grid.Unified Performance (ISUP), Mean Absolute Relative Difference (MARD) and Consensus Error Grid (CEG) distribution.
Generation of predictive algorithms for determining blood glucose levels
时间窗: 12 months
Collected spectral raman data will found the development of predictive algorithms for glucose determination.
次要结局
- Risk/benefit analysis(12 months)
- Number of encountered Device Deficiencies(12 months)