SKAMo-1: Characterization of the Upper Layers of Skin

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Other: Experimental

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • Chu Grenoble Alpes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Skin characterization	Other: Experimental; 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Eclypia

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): April 27, 2023
• Study Completion (Actual): April 27, 2023

Study Registration Dates

• First Submitted: August 7, 2023
• First Submitted That Met QC Criteria: September 13, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2022-A02578-35

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No