Skin barrier and subcutaneous changes from insulin pumps and glucose monitors in children
The Skin Barrier in Users of Diabetes Devices - Showing the Path to New Way to Prevent and Cure Skin Complications
This project will test, in children with type 1 diabetes who use insulin pumps or continuous glucose monitors, how those devices affect the skin and subcutaneous tissue and whether steps like rotation, barrier creams, or different adhesives help the skin recover.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Sponsor | Linkoeping University Government |
| Locations | 1 site (Linköping) |
| Trial ID | NCT06856954 on ClinicalTrials.gov |
What this trial studies
This is an observational study using imaging and clinical measurements to characterize how device attachment affects skin barrier function, microcirculation and subcutaneous tissue in people with type 1 diabetes. Investigators will use Tissue Viability Imaging (TiVI) to measure microcirculation and ultrasound to detect subcutaneous changes such as lipohypertrophy, and will record device type, adhesive/patch material and attachment time. The study will compare recent application sites and follow recovery over time, and will record use of preventive strategies such as steroids, liquid barrier creams or local anesthetic. Results will be used to compare materials (e.g., hydrocolloid or silicone) and care practices for their association with skin injury and recovery time.
Who should consider this trial
Good fit: Ideal candidates are people with type 1 diabetes (especially children) who currently use an insulin pump or continuous glucose monitor and can read Swedish or English.
Not a fit: Patients who do not use skin-attached diabetes devices or who cannot communicate in Swedish or English are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help reduce skin reactions and improve device comfort and glucose stability by guiding better site care and product choices.
How similar studies have performed: Previous work has documented lipohypertrophy and contact dermatitis from diabetes devices, but combining microcirculation imaging (TiVI), ultrasound and systematic comparisons of adhesives and barrier strategies is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Linköping
- Crown Princess Victoria Children´s Hospital — Linköping, Sweden (Recruiting)
Study contacts
- Principal investigator: Jannet Svensson, PhD — Steno Diabetes Center Copenhagen
- Study coordinator: Jannet Svensson, PhD
- Email: jannet.svensson.01@regionh.dk
- Phone: +45 25488355
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.