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RecruitingNCT07767461StenoAD1Updated Aug 25, 2026

Exploring Skin Barrier Function, Recurrence of Diabetes Device-Related Contact Dermatitis, and Evaluation of Hydrocolloid and Silicone-Based Patches for Its Prevention in Children and Adolescents With Type 1 Diabetes

An interventional study of hydrocolloid patch as patch used in the Sandwich method and Silicone-based patch as patch used in the Sandwitch method in Contact Dermatitis and Type 1 Diabetes Mellitus, sponsored by Steno Diabetes Center Copenhagen. Recruiting at 1 site in Denmark. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by Steno Diabetes Center Copenhagen · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
2 Years to 18 Years
Sex
All
01

Study summary

The goal of this clinical trial is to ensure that contact dermatitis does not prevent any person with diabetes from accessing optimal diabetes treatment.

The main questions this study aims to answer are:

How many pediatric patients with diabetes device-related contact dermatitis experience recurrence of contact dermatitis depending on the type of patch used underneath their device? Is one type of patch (silicone-based or hydrocolloid) more effective than the other at preventing contact dermatitis?

The study population consists of children and adolescents aged 2-18 years with contact dermatitis (CD) caused by either an insulin pump or a continuous glucose monitor (CGM).

Participants will be asked to complete questionnaires about their well-being and attend three in-person study visits. During these visits, the following assessments will be performed:

Clinical skin examination Skin photographs of the most recently used insulin pump site, CGM site, and any reported skin reactions Measurement of height and weight Blood sample for measurement of long-term blood glucose (HbA1c) and filaggrin gene mutations Interview about skin reactions and related symptoms Skin ultrasound Tape stripping of the skin Electrical impedance spectroscopy (EIS), a non-invasive technique that transmits a harmless electrical signal through the skin

02

Conditions studied

  • Contact Dermatitis
  • Type 1 Diabetes Mellitus

Keywords

  • skin barrier
  • contact dermatitis
  • T1D
  • Type 1 Diabetes Mellitus
  • Hydrocolloid patch
  • silicone-based patch
  • pediatric
  • device-related contact dermatitis
  • adhesive
  • children and adolescents
03

In context

Dermatitis, Contact

61 studies on the registry are indexed under Dermatitis, Contact; 8 are open to participants now.

This study's planned enrollment of 30 is below the median of 47 across 49 interventional studies indexed under Dermatitis, Contact.

Browse Dermatitis, Contact studies →

Lead sponsor

Steno Diabetes Center Copenhagen is the lead sponsor of 113 studies on the registry; 22 are open to participants now.

Browse Steno Diabetes Center Copenhagen studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • An type of contact dermatitis caused by an insulin pump or a continuous glucose monitor (CGM)
  • Age between 2-18 years prior to inclusion

Exclusion criteria

Exclusion Criteria:

  • Inability to read and understand Danish
  • Cognitive impairment that may interfere with the ability to complete questionnaires in Danish or to participate in telephone or video follow-up visits
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Hydrocolloid patch as patch used in the Sandwitch method

    Other: hydrocolloid patch as patch used in the Sandwich method

  • Active comparator
    Hypafix skin-sensitive patch as patch used in the Sandwitch method

    Other: Silicone-based patch as patch used in the Sandwitch method

Interventions

  • Otherhydrocolloid patch as patch used in the Sandwich method

    We are testing the hydrocolloid patch called Weloa Sensipatch

  • OtherSilicone-based patch as patch used in the Sandwitch method

    Hypafix skin-sensitive patch as patch used in the Sandwitch method

06

What researchers measure

Primary outcomes

  1. Recurrence of contact dermatitis

    the binary outcome recurrence of contact dermatitis

    Time frame: Assessments will be performed at baseline, 3 months, and 6 months.

Secondary outcomes

  1. Time in days to recurrence of contact dermatitis

    Time frame: Baseline to 6 months after.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — We are still investigating the possibilities under Danish ethical and data processing laws.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for May 2027, 8 months later.

Of 21 interventional studies with no phase under Dermatitis, Contact, half reached primary completion within 3 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 21. This study's planned 8 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2026
First posted
Aug 17, 2026
StartEst.
Sep 4, 2026
Primary completionEst.
May 2027
CompletionEst.
May 2027
Last update
Aug 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07767461
Lead sponsor
Steno Diabetes Center Copenhagen
Responsible party
Anna Korsgaard Berg (Researcher, Principal Investigator, Steno Diabetes Center Copenhagen) — Principal investigator
First posted
Aug 17, 2026
Start date
Sep 4, 2026 (estimated)
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Aug 25, 2026

Study contacts

Anna K Berg, MD, PhD
Contact
anna.korsgaard.berg@regionh.dk
+45 22 39 35 90
Fiona Marie W Sorensen, MD
Contact
+45 50 11 01 31
Jannet Svensson, Professor
study chair · Steno Diabetes Center Copenhagen

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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