Performance Evaluation of a Novel Non-invasive Glucometer, Calibrated Against Validated Interstitial Glucose References
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Generation and validation of prediction models - MARD
研究概览
简要总结
This clinical study has been launched to collect spectral Raman data on the Investigational Medical Device (IMD) compared with reference methods in terms of interstitial fluid samples and capillary and venous references.
详细描述
Subjects will visit the clinic for a baseline visit and two in-clinic visits. On in-clinic days, subjects will attend the clinic in a fasting state. They will have inserted a Dexcom and Freestyle Libre and a microdialysis catheter. At time = 0, subjects will be administered a glucose rich drink and every 6. minut measurements will be performed. These include a measurement on the IMD, microdialysate, FreeStyle Libre and Dexcom readings. Every 18. minut a venous blood sample will be included and every 36. minut a capillary blood sample will be collected. This continues until time = 180 minutes.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects 18-70 years old
- •Patients diagnosed with type 1 or type 2 diabetes (T1D or T2D) (insulin requiring T2D patients)
- •Diabetes management strategy: lifestyle regimen + insulin ± oral hypoglycemic agents
- •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
- •> 10 cigarettes pr. day
- •Participants not able to understand and read Swedish
- •In investigator's opinion, participant 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
- •Rejection by screening optical measurements
- •Known allergy to medical grade alcohol
- •Known allergy to adhesives
- •Systemic or topical administration of glucocorticoids for the past 7 days
- •Participants undergoing dialysis treatment
- •Anti-coagulation or anti-platelet therapy
- •Use of beta-blockers
- •Medical conditions causing bleeding tendency
- •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. Such conditions include but are not limited to HIV and Hepatitis B or C.
- •Participants currently enrolled in another study
研究组 & 干预措施
RSP-08
All subjects undergo the same procedures. Subjects will be subjected to measurements on the IMD (Working Model 3.4NR), FreeStyle Libre, Dexcom, microdialysis, venous and capillary blood collection.
干预措施: Working Model 3.4NR (Device)
结局指标
主要结局
Generation and validation of prediction models - MARD
时间窗: One year
Two in-clinic visits each of a duration of 5-6 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected. Optical glucose readings will be masked to the subjects. Collected data will be used to generate individual calibration models capable of predicting tissue glucose. Models will be validated on independent data sets using Mean Absolute Relative Difference (MARD) endpoint measure.
Generation and validation of prediction models - ISUP
时间窗: One year
Two in-clinic visits each of a duration of 5-6 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected. Optical glucose readings will be masked to the subjects. Collected data will be used to generate individual calibration models capable of predicting tissue glucose. Models will be validated on independent data sets using Inter Subject Unified Performance (ISUP) measure.
Generation and validation of prediction models - Consensus Error Grid
时间窗: One year
Two in-clinic visits each of a duration of 5-6 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected. Optical glucose readings will be masked to the subjects. Collected data will be used to generate individual calibration models capable of predicting tissue glucose. Models will be validated on independent data sets using Consensus Error Grid Analysis
次要结局
- Safety evaluation: paucity of adverse events(One year)
- Evaluation of dynamics between arterial and venous glucose profiles in relation to interstitial glucose levels(One year)