Continuous temperature monitoring of the feet with connected insoles and a smartphone app in adults with diabetes at high risk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates a self-monitoring system (Solsius SelfCare) that uses connected insoles and a mobile app to detect pre-ulcerative foot abnormalities in adults with type 1 or type 2 diabetes at high podiatric risk. Participants wear the insoles daily for 12 months, receiving a push notification when a bilateral plantar temperature difference of 2.2°C or more is observed on two consecutive days. The primary question is whether the system can achieve at least 80% sensitivity in identifying clinically confirmed abnormalities, with no separate control group. Enrollment targets adults with a history of a healed foot ulcer and HAS grade 3 risk, meeting other medical and technical eligibility criteria, across three French sites. The study aligns with IWDF 2023 guidance on daily foot temperature monitoring for high-risk individuals.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hôpital Saint-Vincent de Paul [GHICL]
  Lille, France Recruiting
• CHU de Lille
  Lille, France Recruiting
• CHU de Montpellier
  Montpellier, France Not yet recruiting

Study contacts

• Principal investigator: Ariane Sultan
• Study coordinator: Rodolphe Renault
• Email: a-sultan@chu-montpellier.fr
• Phone: +33 6 60 78 21 12

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.