NCT06044532已完成不适用
SKAMo-1: Characterization of the Upper Layers of Skin
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Eclypia
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Change of skin hydration on the dorsum of the forearm after two and a half hours of wearing the sham device.
研究概览
简要总结
Diabetes is a frequent disease characterized by chronic hyperglycemia, and its prevalence is increasing worldwide. Historically, patients with diabetes were required to monitor capillary blood glucose concentration up to several times a day through fingertip sampling.
Recently marketed devices now allow measurements of interstitial fluid blood glucose continuously, thus limiting pain associated with sampling. However, they are still invasive and have to be changed every 14 days.
Therefore, to optimize continuous glycemia monitoring while avoiding pain, discomfort, and the risk of infection, non-invasive methods are needed. Among the different strategies being developed, optical wearable sensors with specific signal processing are a promising option. The sensors detecting this optical signal will be included in a device. Yet, wearing a device may slightly modify several properties of the skin, such as its humidity and thermal regulation, and subsequently have an impact on the measured optical signal. Therefore, it is important to better understand how a device affects these characteristics to include these parameters in the future device algorithms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged ≥ 18 years and ≤ 60 years
- •Signed informed consent
- •Person who is affiliated to a social security scheme or who is beneficiary of such a scheme
排除标准
- •Body mass index (BMI) > 30 kg/m2
- •Any acute or chronic disease with vascular impact
- •Any cutaneous disease on sites implicated in the study (dorsum of the forearm)
- •Allergy to one of the material used in the sham device and during the procedure of the study
- •The persons mentioned in articles L1121-5 to L1121-8 of the public health code may not be included in this research
- •Subject who would receive more than 4500 euros in compensation due to his or her participation in other research involving the human person in the 12 months preceding this study
结局指标
主要结局
Change of skin hydration on the dorsum of the forearm after two and a half hours of wearing the sham device.
时间窗: Visit 1,Day 0, before and after two and a half hours of wearing the sham device
Hydration is measured with a capacitance method, expressed as arbitrary units (dielectric value)
次要结局
- Change of transepidermal water loss after the wearing the sham device(Visit 1,Day 0, before and after two and a half hours of wearing the sham device)
- Change of thickness of the stratum corneum after skin cleaning(Visit 1, Day 0, in 30 minutes, measures taken before and after skin cleaning)
- Change of thickness of the stratum corneum after the wearing the sham device(Visit 1,Day 0, before and after two and a half hours of wearing the sham device)
- Change of skin temperature after the wearing the sham device(Visit 1,Day 0, before and after two and a half hours of wearing the sham device)
- Change of skin blood flux after the wearing the sham device(Visit 1,Day 0, before and after two and a half hours of wearing the sham device)
- Change of skin temperature after skin cleaning(Visit 1, Day 0, in 30 minutes, measures taken before and after skin cleaning)
- Change of skin elasticity after skin sanding(Visit 1, Day 0, in 30 minutes, measures taken before and after skin sanding)
- Change of thickness of the stratum corneum after skin sanding(Visit 1, Day 0, in 30 minutes, measures taken before and after skin sanding)
- Change of skin blood flux after skin sanding(Visit 1, Day 0, in 30 minutes, measures taken before and after skin sanding)
- Change of skin hydration after skin cleaning(Visit 1, Day 0, in 30 minutes, measures taken before and after skin cleaning)
- Change of transepidermal water loss after skin sanding(Visit 1, Day 0, in 30 minutes, measures taken before and after skin sanding)
- Change of skin temperature after skin sanding(Visit 1, Day 0, in 30 minutes, measures taken before and after skin sanding)
- Change of thickness of the stratum corneum after local heating(Visit 2, Day 7 (+/-6 days) before and after local heating (40 minutes local thermal heating between 33 to 43°C with probes PF457))
- Change of skin elasticity after the wearing the sham device(Visit 1,Day 0, before and after two and a half hours of wearing the sham device)
- Change of skin blood flux after skin cleaning(Visit 1, Day 0, in 30 minutes, measures taken before and after skin cleaning)
- Change of skin elasticity after skin cleaning(Visit 1, Day 0, in 30 minutes, measures taken before and after skin cleaning)
- Change of transepidermal water loss after skin cleaning(Visit 1, Day 0, in 30 minutes, measures taken before and after skin cleaning)
- Change of skin hydration after skin sanding(Visit 1, Day 0, in 30 minutes, measures taken before and after skin sanding)
- Change of transepidermal water loss after local heating(Visit 2, Day 7 (+/-6 days) before and after local heating (40 minutes local thermal heating between 33 to 43°C with probes PF457))
- Change of skin temperature after local heating(Visit 2, Day 7 (+/-6 days) before and after local heating (40 minutes local thermal heating between 33 to 43°C with probes PF457))
- Change of skin hydration after local heating(Visit 2, Day 7 (+/-6 days), before and after local heating (40 minutes local thermal heating between 33 to 43°C with probes PF457))
- Change of skin elasticity after local heating(Visit 2, Day 7 (+/-6 days), before and after local heating (40 minutes local thermal heating between 33 to 43°C with probes PF457))
- Change of skin elasticity induced by oral glycemia tolerance test(Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours))
- Change of skin blood flux induced by oral glycemia tolerance test(Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours))
- Change of skin temperature induced by oral glycemia tolerance test(Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours))
- Change of skin hydration induced by oral glycemia tolerance test(Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours))
- Change of transepidermal water loss induced by oral glycemia tolerance test(Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours))
- Change of skin blood flux after local heating(Visit 2, Day 7 (+/-6 days) before and after local heating (40 minutes local thermal heating between 33 to 43°C with probes PF457))
- Change of thickness of the stratum corneum induced by oral glycemia tolerance test(Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours))
研究者
研究点 (2)
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