SKAMo-1: Characterization of the Upper Layers of Skin

September 13, 2023 updated by: Eclypia

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • CHU Grenoble Alpes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: 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)
Visit 1,Day 0, before and after two and a half hours of wearing the sham device

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of skin elasticity after the wearing the sham device
Time Frame: Visit 1,Day 0, before and after two and a half hours of 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
Time Frame: Visit 1,Day 0, before and after two and a half hours of 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
Time Frame: Visit 1,Day 0, before and after two and a half hours of 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
Time Frame: Visit 1,Day 0, before and after two and a half hours of 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
Time Frame: Visit 1,Day 0, before and after two and a half hours of 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
Time Frame: Visit 1, Day 0, in 30 minutes, measures taken before and 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
Time Frame: Visit 1, Day 0, in 30 minutes, measures taken before and 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
Time Frame: Visit 1, Day 0, in 30 minutes, measures taken before and 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
Time Frame: Visit 1, Day 0, in 30 minutes, measures taken before and 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
Time Frame: Visit 1, Day 0, in 30 minutes, measures taken before and 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
Time Frame: Visit 1, Day 0, in 30 minutes, measures taken before and 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
Time Frame: Visit 1, Day 0, in 30 minutes, measures taken before and 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
Time Frame: Visit 1, Day 0, in 30 minutes, measures taken before and 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
Time Frame: Visit 1, Day 0, in 30 minutes, measures taken before and 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
Time Frame: Visit 1, Day 0, in 30 minutes, measures taken before and 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
Time Frame: Visit 1, Day 0, in 30 minutes, measures taken before and 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
Time Frame: Visit 1, Day 0, in 30 minutes, measures taken before and 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
Time Frame: Visit 2, Day 7 (+/-6 days), before and after local heating (40 minutes local thermal heating between 33 to 43°C with probes PF457)
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
Time Frame: Visit 2, Day 7 (+/-6 days), before and after local heating (40 minutes local thermal heating between 33 to 43°C with probes PF457)
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
Time Frame: Visit 2, Day 7 (+/-6 days) before and after local heating (40 minutes local thermal heating between 33 to 43°C with probes PF457)
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
Time Frame: Visit 2, Day 7 (+/-6 days) before and after local heating (40 minutes local thermal heating between 33 to 43°C with probes PF457)
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
Time Frame: Visit 2, Day 7 (+/-6 days) before and after local heating (40 minutes local thermal heating between 33 to 43°C with probes PF457)
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
Time Frame: Visit 2, Day 7 (+/-6 days) before and after local heating (40 minutes local thermal heating between 33 to 43°C with probes PF457)
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
Time Frame: Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours)
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
Time Frame: Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours)
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
Time Frame: Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours)
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
Time Frame: Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours)
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
Time Frame: Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours)
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
Time Frame: Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eclypia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 27, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 27, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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