Skin barrier and subcutaneous changes from insulin pumps and glucose monitors in children
Official title: The Skin Barrier in Users of Diabetes Devices - Showing the Path to New Way to Prevent and Cure Skin Complications
Run by Linkoeping University · NCT06856954 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 2 Years to 17 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Linkoeping University Government |
| Locations | 1 site (Linköping) |
| Status | Recruiting |
| Started | March 10, 2025 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | September 9, 2025 |
| Trial ID | NCT06856954 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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VV-14300: a gene therapy approach for adults with type 1 diabetes not well controlled on an automated insulin system
This trial tests VV-14300 in adults with type 1 diabetes who aren’t reaching their blood sugar goals despite using an automated insulin delivery system.
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New gene therapies VV-14299 and VV-14300 for adults with Type 1 Diabetes failing automated insulin delivery
This study tests VV-14299 and VV-14300, or VV-14300 alone, in adults with long-standing Type 1 Diabetes whose blood sugar remains poorly controlled despite using an automated insulin delivery system.
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Oral verapamil in newly diagnosed children and teens with type 1 diabetes
This study tests whether taking verapamil by mouth can help preserve pancreatic beta cells and reduce insulin needs in kids and teens with recently diagnosed type 1 diabetes.
-
Preventing device-related skin rashes in kids with type 1 diabetes using hydrocolloid vs silicone patches
This study tests whether silicone-based or hydrocolloid patches help prevent recurring skin irritation from insulin pumps or CGMs in children and teens with type 1 diabetes.
-
AI-assisted remote insulin pump optimization for people with type 1 diabetes
This study tests an AI-powered tool that suggests insulin pump settings for people with type 1 diabetes, with doctor-approved recommendations delivered to a mobile app.
-
Near-sensor insulin delivery with CGM in people with type 1 diabetes
A small early-feasibility study tests a dual-port insulin patch pump that includes a CGM sensor to see if delivering insulin near the sensor affects glucose readings and whether an automated control algorithm can manage glucose.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.