The Skin Barrier in Users of Diabetes Devices - Showing the Path to New Way to Prevent and Cure Skin Complications

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: f
View:

• diagnosed with type 1 diabetes

• using diabetes device attached to the skin (insulin pump or CGM)

Locations
Other Locations
Sweden
Crown Princess Victoria Children´s Hospital
RECRUITING
Linköping
Contact Information
Primary
Jannet Svensson, PhD
jannet.svensson.01@regionh.dk
+45 25488355
Backup
Pär A White, MD, PhD
par.andersson.white@regionostergotland.se
+46 701760188
Time Frame
Start Date: 2025-03-10
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 150
Sponsors
Collaborators: Linkoeping University
Leads: Jannet Svensson

This content was sourced from clinicaltrials.gov

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