SKAMo-1: Characterization of the Upper Layers of Skin

NCT06044532 | Completed

• 1 other identifier: 2022-A02578-35
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (29)

• 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 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 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

Study Arms (1)

Skin characterization

EXPERIMENTAL

Other: Experimental

Interventions

Experimental OTHER

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.

Skin characterization

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eclypia: lead

Study Sites (1)

CHU Grenoble Alpes

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: September 21, 2023
• Study Start: March 1, 2023
• Primary Completion: April 27, 2023
• Study Completion: April 27, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

FR (1)