SKAMo-1: Characterization of the Upper Layers of Skin

Study Overview
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Brief Summary
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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.

Official Title
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SKAMo-1: Characterization of the Upper Layers of Skin

Conditions
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Diabetes

Intervention / Treatment
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* Other: Experimental


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skin characterization<br> | Other: Experimental<br>* At the first visit, effects of skin preparations (cleaning or sanding) on skin parameters and wearing a sham device will be evaluated. At the second visit the effect on skin parameters of a local heating and an OGTT will be evaluated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of skin hydration on the dorsum of the forearm after two and a half hours of wearing the sham device. | Hydration is measured with a capacitance method, expressed as arbitrary units (dielectric value) | Visit 1,Day 0, before and after two and a half hours of wearing the sham device | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of skin elasticity after the wearing the sham device | elasticity (suction method) expressed as penetration depth in mm/time | Visit 1,Day 0, before and after two and a half hours of wearing the sham device | 
| Change of transepidermal water loss after the wearing the sham device | transepidermal water loss (the density gradient of the water evaporation) expressed as the evaporation rate in g/h/m2 | 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 the wearing the sham device | thickness of the stratum corneum (LC-OCT method) expressed as mm | 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 | skin temperature (infrared thermography) expressed as Celsius, | 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 | skin blood flux (LSCI) expressed as an arbitrary unit, | Visit 1,Day 0, before and after two and a half hours of wearing the sham device | 
| Change of skin hydration after skin cleaning | expressed as previously described | Visit 1, Day 0, in 30 minutes, measures taken before and after skin cleaning | 
| Change of skin elasticity after skin cleaning | expressed as previously described | Visit 1, Day 0, in 30 minutes, measures taken before and after skin cleaning | 
| Change of transepidermal water loss after skin cleaning | expressed as previously described | Visit 1, Day 0, in 30 minutes, measures taken before and after skin cleaning | 
| Change of thickness of the stratum corneum after skin cleaning | expressed as previously described | Visit 1, Day 0, in 30 minutes, measures taken before and after skin cleaning | 
| Change of skin temperature after skin cleaning | expressed as previously described | Visit 1, Day 0, in 30 minutes, measures taken before and after skin cleaning | 
| Change of skin blood flux after skin cleaning | expressed as previously described | Visit 1, Day 0, in 30 minutes, measures taken before and after skin cleaning | 
| Change of skin hydration after skin sanding | expressed as previously described | Visit 1, Day 0, in 30 minutes, measures taken before and after skin sanding | 
| Change of skin elasticity after skin sanding | expressed as previously described | Visit 1, Day 0, in 30 minutes, measures taken before and after skin sanding | 
| Change of transepidermal water loss after skin sanding | expressed as previously described | Visit 1, Day 0, in 30 minutes, measures taken before and after skin sanding | 
| Change of thickness of the stratum corneum after skin sanding | expressed as previously described | Visit 1, Day 0, in 30 minutes, measures taken before and after skin sanding | 
| Change of skin temperature after skin sanding | expressed as previously described | Visit 1, Day 0, in 30 minutes, measures taken before and after skin sanding | 
| Change of skin blood flux after skin sanding | expressed as previously described | Visit 1, Day 0, in 30 minutes, measures taken before and after skin sanding | 
| Change of skin hydration after local heating | expressed as previously described | 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 | expressed as previously described | 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 transepidermal water loss after local heating | expressed as previously described | 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 after local heating | expressed as previously described | 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 | expressed as previously described | 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 blood flux after local heating | expressed as previously described | 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 induced by oral glycemia tolerance test | expressed as previously described | Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours) | 
| Change of skin elasticity induced by oral glycemia tolerance test | expressed as previously described | 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 | expressed as previously described | Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours) | 
| Change of thickness of the stratum corneum induced by oral glycemia tolerance test | expressed as previously described | 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 | expressed as previously described | 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 | expressed as previously described | Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours) |