Feasibility of Non-invasive Glucose Monitoring by Using Photothermal Deflectometry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Accuracy of non-invasive glucose measurement in comparison to invasive glucose measurement
研究概览
简要总结
This study aims to evaluate the feasibility of non-invasive glucose monitoring by using photothermal deflectometry in the interstitial fluid of the skin on the wrist of subjects with diabetes mellitus type 1 and 2.
详细描述
The investigation is designed as an open, monocentric, non-randomized, single-arm, explorative study in adult subjects without diabetes and with type 1 or 2 diabetes mellitus (any therapy form).
The clinical investigation will be performed in an outpatient setting on up to three study days with up to 36 subjects. At least 6 subjects shall be included in each of the three subgroups (type 1 diabetes, type 2 diabetes, no diabetes)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Clinical diagnosis of type 1 OR type 2 diabetes OR no diabetes
- •For subjects with diabetes: glycated haemoglobin (HbA1c) <10%
- •Age ≥ 18 years
- •Male or female or diverse
- •An understanding of and willingness to follow the protocol
- •Signed informed consent
排除标准
- •Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment
- •Hypoglycemia unawareness
- •Have extensive skin changes/diseases at the proposed measurement site (wrist and upper arm for FreeStyle Libre 3) that could interfere with the accuracy of glucose measurements.
- •Female subjects: pregnancy, lactation period, lack of a negative pregnancy test (except in case of menopause, sterilization or hysterectomy)
- •Serious acute or chronic disease besides diabetes mellitus or an anamnesis which might, in the opinion of the investigator, pose a risk to the subject, e.g. seizure disorder, adrenal disorder, dialysis for renal failure, cystic fibrosis, active infection
- •Severe diabetes related complications (i.e. macro angiopathy, severe micro angiopathy, severe neuro-, retino- or nephropathy) when unstable (defined by event or increasing symptoms in the last 6 months) or with insufficient therapy
- •Known severe tape reactions or allergies
- •Any incapacity or general condition that, in the opinion of the investigator, prevents adequate compliance with the study procedures, e.g. mental or visual incapacity, tremor, language barriers, alcohol or drug misuse
- •Not able to understand, write or read German
- •Dependency from the sponsor or the clinical investigator
结局指标
主要结局
Accuracy of non-invasive glucose measurement in comparison to invasive glucose measurement
时间窗: 3-13 days per subject
The accuracy of glucose values determined by D-Base 2.0 Prototype B in comparison with Contour Next (CNXT) values (non-invasive vs invasive glucose measurement) is determined by the following specific analysis: * Number and percentage of D-Base 2.0 Prototype B results within ±15 mg/dl or ±15% as well as ±20 mg/dl or ±20% and ±30 mg/dl or ±30% of mean CNXT results for mean CNXT results \<100 mg/dl or ≥100 mg/dl, respectively
次要结局
未报告次要终点