Clinical trial NCT06044532: SKAMo-1: Characterization of the Upper Layers of Skin
Official title: SKAMo-1: Characterization of the Upper Layers of Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Eclypia
Sponsor class: INDUSTRY
First posted: 2023-09-21
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of skin hydration on the dorsum of the forearm after two and a half hours of wearing the sham device.
timeFrame: Visit 1,Day 0, before and after two and a half hours of wearing the sham device
Secondary outcomes:
measure: Change of skin elasticity after the wearing the sham device
timeFrame: Visit 1,Day 0, before and after two and a half hours of wearing the sham device
measure: Change of transepidermal water loss after the wearing the sham device
timeFrame: Visit 1,Day 0, before and after two and a half hours of wearing the sham device
measure: Change of thickness of the stratum corneum after the wearing the sham device
timeFrame: Visit 1,Day 0, before and after two and a half hours of wearing the sham device
measure: Change of skin temperature after the wearing the sham device
timeFrame: Visit 1,Day 0, before and after two and a half hours of wearing the sham device
measure: Change of skin blood flux after the wearing the sham device
timeFrame: Visit 1,Day 0, before and after two and a half hours of wearing the sham device
measure: Change of skin hydration after skin cleaning
timeFrame: Visit 1, Day 0, in 30 minutes, measures taken before and after skin cleaning
measure: Change of skin elasticity after skin cleaning
timeFrame: Visit 1, Day 0, in 30 minutes, measures taken before and after skin cleaning
measure: Change of transepidermal water loss after skin cleaning
timeFrame: Visit 1, Day 0, in 30 minutes, measures taken before and after skin cleaning
measure: Change of thickness of the stratum corneum after skin cleaning
timeFrame: Visit 1, Day 0, in 30 minutes, measures taken before and after skin cleaning
measure: Change of skin temperature after skin cleaning
timeFrame: Visit 1, Day 0, in 30 minutes, measures taken before and after skin cleaning
measure: Change of skin blood flux after skin cleaning
timeFrame: Visit 1, Day 0, in 30 minutes, measures taken before and after skin cleaning
measure: Change of skin hydration after skin sanding
timeFrame: Visit 1, Day 0, in 30 minutes, measures taken before and after skin sanding
measure: Change of skin elasticity after skin sanding
timeFrame: Visit 1, Day 0, in 30 minutes, measures taken before and after skin sanding
measure: Change of transepidermal water loss after skin sanding
timeFrame: Visit 1, Day 0, in 30 minutes, measures taken before and after skin sanding
measure: Change of thickness of the stratum corneum after skin sanding
timeFrame: Visit 1, Day 0, in 30 minutes, measures taken before and after skin sanding
measure: Change of skin temperature after skin sanding
timeFrame: Visit 1, Day 0, in 30 minutes, measures taken before and after skin sanding
measure: Change of skin blood flux after skin sanding
timeFrame: Visit 1, Day 0, in 30 minutes, measures taken before and after skin sanding
measure: Change of skin hydration after local heating
timeFrame: Visit 2, Day 7 (+/-6 days), before and after local heating (40 minutes local thermal heating between 33 to 43°C with probes PF457)
measure: Change of skin elasticity after local heating
timeFrame: Visit 2, Day 7 (+/-6 days), before and after local heating (40 minutes local thermal heating between 33 to 43°C with probes PF457)
measure: Change of transepidermal water loss after local heating
timeFrame: Visit 2, Day 7 (+/-6 days) before and after local heating (40 minutes local thermal heating between 33 to 43°C with probes PF457)
measure: Change of thickness of the stratum corneum after local heating
timeFrame: Visit 2, Day 7 (+/-6 days) before and after local heating (40 minutes local thermal heating between 33 to 43°C with probes PF457)
measure: Change of skin temperature after local heating
timeFrame: Visit 2, Day 7 (+/-6 days) before and after local heating (40 minutes local thermal heating between 33 to 43°C with probes PF457)
measure: Change of skin blood flux after local heating
timeFrame: Visit 2, Day 7 (+/-6 days) before and after local heating (40 minutes local thermal heating between 33 to 43°C with probes PF457)
measure: Change of skin hydration induced by oral glycemia tolerance test
timeFrame: Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours)
measure: Change of skin elasticity induced by oral glycemia tolerance test
timeFrame: Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours)
measure: Change of transepidermal water loss induced by oral glycemia tolerance test
timeFrame: Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours)
measure: Change of thickness of the stratum corneum induced by oral glycemia tolerance test
timeFrame: Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours)
measure: Change of skin temperature induced by oral glycemia tolerance test
timeFrame: Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours)
measure: Change of skin blood flux induced by oral glycemia tolerance test
timeFrame: Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours)
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble Alpes
Study officials:
References: