NCT06856954 The Skin Barrier in Users of Diabetes Devices
| NCT ID | NCT06856954 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jannet Svensson |
| Condition | Type 1 Diabetes Mellitus |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-03-10 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2025-03-10 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Diabetes technology (insulin pumps and continuous glucose monitoring) have become standard of care in children with type 1 diabetes. Unfortunately, the attachment of the devices to the skin can provoke injury, irritative or allergic eczema of the skin. Additionally, the continuous insulin infusion often causes sub-cutaneous lipohypertrophy. These occurrences are likely to increase blood glucose fluctuation and impact burden of diabetes. In collaboration with dermatologists, the propose is to investigate the skin microcirculation and skin barrier as well as the subcutaneous tissue when exposed to insulin, occlusion, irritative and allergenic features of the part of device in close contact with the skin. Secondly, investigate the skin barrier and recovery time as a function of time since exposure, type of patches/device and use of preventive strategies like steroids, liquid barrier crème or local anesthetic. To study microcirculation the investgators use Tissue Viability Imaging (TiVI) a non-invasive method using polarization light spectroscopy to count red blood cells thereby saying something about the microcirculation. To investigate skin barrier, the investigators use electric impedance spectroscopy (EIS) which is a non-invasive method sending small electric current of different frequencies through the skin surface. The different frequencies have different properties regarding penetration of cells making it possible to measure the resistance towards each frequency. In this way give a measure of the skin barrier. The last methods investigators are using is ultrasound a non-invasive method that uses sound to show different structures in the subcutaneous tissue, it has been demonstrated to be better than visual inspection to detect lipohypertrophy in the subcutaneous tissue. Lipohypertrophy is often seen in places with repeated infusion/injection of insulin. These investigations are necessary to motivate and guide the development of new materials for diabetes devices and provide clinical guidelines regarding device position and site rotation in order to prevent skin complications from interfering with optimal treatment. This could lead to improved short and long-term outcome in the care of persons with diabetes.
Eligibility Criteria
Inclusion Criteria: * diagnosed with type 1 diabetes * using diabetes device attached to the skin (insulin pump or CGM) Exclusion Criteria: * Do not use diabetes device attached to the skin. * Those unable to read and understand Swedish or English * impaired cognitive development that may interfere with the ability to answer questionnaires in Swedish/English and/or be reached by phone.
Contact & Investigator
Jannet Svensson, PhD
PRINCIPAL INVESTIGATOR
Steno Diabetes Center Copenhagen
Frequently Asked Questions
Who can join the NCT06856954 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 17 Years, studying Type 1 Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06856954 currently recruiting?
Yes, NCT06856954 is actively recruiting participants. Contact the research team at jannet.svensson.01@regionh.dk for enrollment information.
Where is the NCT06856954 trial being conducted?
This trial is being conducted at Linköping, Sweden.
Who is sponsoring the NCT06856954 clinical trial?
NCT06856954 is sponsored by Jannet Svensson. The principal investigator is Jannet Svensson, PhD at Steno Diabetes Center Copenhagen. The trial plans to enroll 150 participants.
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