Connected insoles that track foot temperature to catch early foot problems in diabetes
Tests temperature-sensing insoles in adults with diabetes and a past healed foot wound.
Plain-language title generated from the registry record
Registry title: Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
Key facts
- Where
- Lille and Montpellier, FranceSee the 3 sites
Where in France
- CHU de LilleLille, FranceTaking people
- Hôpital Saint-Vincent de Paul [GHICL]Lille, FranceTaking people
- CHU de MontpellierMontpellier, FranceNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Solsius
- Trial code
- NCT07910721
- Record updated
- 2 November 2026
- Original description
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.Read full original descriptionShow less
Prevention of Diabetic Foot Ulcers Through Self-monitoring: a Performance Evaluation Study (DIAFOOTEM)
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
Inclusion: 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: Patient previously enrolled in another interventional clinical study,; History of major lower limb amputation,; 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 with a serious illness likely to lead to premature discontinuation before the end of the study,; Patient with a foot wound,; Patient with acute Charcot foot or active osteomyelitis,; Pregnant or breastfeeding women.