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RECRUITING

NCT07910721

Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.

Sponsor: Solsius

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate the performance of a self-monitoring system (Solsius SelfCare) to detect pre-ulcerative clinical abnormalities in adults living with type 1 or 2 diabetes at high podiatric risk (grade 3 according to French HAS guidelines) and a history of healed diabetic foot wound. The main question it aims to answer is: \- Can the Solsius SelfCare system detect pre-ulcerative foot abnormalities with a sensitivity of at least 80%, defined as the proportion of temperature threshold exceedances (≥ 2.2°C difference between symmetric plantar sites over 2 consecutive days) confirmed by a clinical abnormality identified by a podiatrist? There is no comparison group. All participants will use the same device throughout the study. Participants will: * Wear the Solsius SelfCare connected insoles daily (except during sleep) for 12 months * Receive a push notification on their smartphone if a temperature difference ≥ 2.2°C is detected between symmetric sites on both feet over 2 consecutive days * Attend scheduled podiatric follow-up visits every 3 months (at M3, M6, M9, and M12) * Attend an additional unscheduled podiatric visit within 24 hours after each temperature alert, to verify the presence or absence of a pre-ulcerative clinical abnormality * Complete a self-questionnaire after each temperature alert and a usability questionnaire (System Usability Scale) at the end of the study

Official title: Prevention of Diabetic Foot Ulcers Through Self-monitoring: a Performance Evaluation Study (DIAFOOTEM)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-03-10

Completion Date

2027-04-10

Last Updated

2026-11-02

Healthy Volunteers

Conditions

Diabetic Foot Disease Diabetic Foot Infection Diabetic Foot Infections Diabete Type 1 Diabetes (DM)Foot

Interventions

DEVICE

Solsius SelfCare

Smart insoles incorporating plantar temperature sensors (bilateral measurement), worn daily whilst awake for 12 months. Push notification if the temperature difference between two symmetrical sites is ≥ 2.2°C for two consecutive days. Class I medical device, CE marked in accordance with MDR 2017/745.

Inclusion Criteria: * Patient aged 18 years or older, * Patient living with type 1 or type 2 diabetes, * Patient with a podiatric risk grade of 3 according to Haute Autorité de Santé (HAS) \[19\], * Patient with a history of a foot ulcer healed at least 2 months prior to inclusion, * Patient with an HbA1c or GMI level measured within the last 3 months and below 10%, * Patient able to walk daily, * Patient owning a smartphone equipped with Bluetooth Low Energy 4.1 technology (Android 9 and iOS 15 or later), compatible with the technical requirements of the insoles and able to connect to the internet (via a cellular plan or Wi-Fi), * Patient willing to install the Solsius SelfCare application and comply with the procedures for using the insoles and participating in the study, Patient considered autonomous by the investigator and able to follow the study protocol, * Patient affiliated with or benefiting from a Social Security system, * Patient able to understand or read French, * Patient wearing shoe sizes 36 to 45. Exclusion Criteria: * Patient with a foot wound, * History of major lower limb amputation, * Patient with acute Charcot foot or active osteomyelitis, * Patient presenting at baseline with any of the following plantar abnormalities: redness; hyperkeratotic plaques; corns, calluses, or thickened skin; blisters; foot edema; cracks or fissures; nail abnormalities (ingrown, painful, or thickened nails); discharge; interdigital fungal infection; early-stage wound or ulcer, * Patient with severe cognitive impairment significantly limiting their ability to concentrate and preventing them from following the device usage instructions, * Adult patients under legal protection measures (guardianship, judicial protection, psychiatric care, or deprived of liberty by judicial or administrative decision), * Patient previously enrolled in another interventional clinical study, * Patient with a serious illness likely to lead to premature discontinuation before the end of the study, * Pregnant or breastfeeding women.

Locations (3)

Hôpital Saint-Vincent de Paul [GHICL]

Lille, France

CHU de Lille