SKAMo-1: Characterization of the Upper Layers of Skin

NCT ID: NCT06044532

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2023-04-27

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Skin characterization

Group Type: EXPERIMENTAL

Experimental

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eclypia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Grenoble Alpes

Grenoble, , France

Countries

France

Other Identifiers

2022-A02578-35

Identifier Type: -

Identifier Source: org_study_id