NCT07910721Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 2 Nov 2026

Brief summary (registry, in English)

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

Status (registry): Recruiting
Study type: Interventional
Enrollment: 60 (estimated)
First submitted: 29 Jul 2026
Start date: 10 Mar 2026
Primary completion date: 10 Apr 2027
Lead sponsor: Solsius
Diseases: Type 1 diabetes
NCT number: NCT07910721

What you commit to

Study type: Interventional
Planned participants: 60
From 10 Mar 2026 to the primary completion date, 10 Apr 2027
3 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Patient previously enrolled in another interventional clinical study,

Other illness

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,

Other

Patient with a foot wound,
Patient with acute Charcot foot or active osteomyelitis,
Pregnant or breastfeeding women.

Who the study is looking for

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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Hôpital Saint-Vincent de Paul [GHICL] Coordinator of this site? Confirm its status	Lille	France	Recruiting
CHU de Lille Coordinator of this site? Confirm its status	Lille	France	Recruiting
CHU de Montpellier Coordinator of this site? Confirm its status	Montpellier	France	Not yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.