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NCT06044532

SKAMo-1: Characterization of the Upper Layers of Skin

Completed NA Last updated 21 September 2023
What this trial tests

NA trial testing Experimental in Diabetes in 14 participants. Completed in 27 April 2023.

Timeline
1 March 2023
Primary endpoint
27 April 2023
27 April 2023

Quick facts

Lead sponsorEclypia
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment14
Start date1 March 2023
Primary completion27 April 2023
Estimated completion27 April 2023
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Eclypia

Who can join

Adults 18 to 60, any sex, with Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Clinical Measurement of Transepidermal Water Loss.
    Kundu D, Jayaraman A, Sen CK. · · 2026 · cited 4× · PMID 40476522 · DOI 10.1089/wound.2024.0148

Verify or expand the search:

Other trials of Experimental

Trials testing the same drug.

Other recruiting trials for Diabetes

Currently open trials in the same condition.

Other Eclypia trials

Trials by the same sponsor.

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Data sources for this page

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