Contact DermatitisStenoAD1NCT07767461
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
A study testing hydrocolloid patch as patch used in the Sandwich method and Silicone-based patch as patch used in the Sandwitch method in people with Contact Dermatitis and Type 1 Diabetes Mellitus, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Contact Dermatitis, Type 1 Diabetes Mellitus
- What is being tested?
- hydrocolloid patch as patch used in the Sandwich method and Silicone-based patch as patch used in the Sandwitch method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Sep 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- An type of contact dermatitis caused by an insulin pump or a continuous glucose monitor (CGM)
- Age between 2-18 years prior to inclusion
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Fiona Marie W Sorensen, MD contact
Denmark1 site, 1 recruiting
- Recruiting
Steno Diabetes Center Copenhagen
Copenhagen
About this study
Official title: Steno Adhesive Study 1
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:
Read more
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
- Conditions
- Contact Dermatitis, Type 1 Diabetes Mellitus
- Being tested
- hydrocolloid patch as patch used in the Sandwich method, Silicone-based patch as patch used in the Sandwitch method
- Keywords
- skin barrier, contact dermatitis, T1D, Type 1 Diabetes Mellitus, Hydrocolloid patch, silicone-based patch, pediatric, device-related contact dermatitis, adhesive, children and adolescents
- Medical subject headings
- Dermatitis, Contact, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrocolloid patch as patch used in the Sandwich methodOther
We are testing the hydrocolloid patch called Weloa Sensipatch
Silicone-based patch as patch used in the Sandwitch methodOther
Hypafix skin-sensitive patch as patch used in the Sandwitch method
| Study group | Role | What they receive |
|---|---|---|
| Hydrocolloid patch as patch used in the Sandwitch method | Experimental | Not described Receives: Other: hydrocolloid patch as patch used in the Sandwich method |
| Hypafix skin-sensitive patch as patch used in the Sandwitch method | Active comparator | Not described Receives: Other: Silicone-based patch as patch used in the Sandwitch method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of contact dermatitis
the binary outcome recurrence of contact dermatitis
Measured: Assessments will be performed at baseline, 3 months, and 6 months.
Secondary outcomes (1)
Time in days to recurrence of contact dermatitis
Measured: Baseline to 6 months after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start4 Sep 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective study consisting of three in-person visits and two remote visits. Each participant will be enrolled in the study for a total of 6 months.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Korsgaard Berg, Steno Diabetes Center Copenhagen
- Investigators
- Jannet Svensson, Professor, Study chair, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767461
- Sponsor's protocol ID
- StenoAD1
- Other IDs
- 16-0302-112
- Acronym
- StenoAD1
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are still investigating the possibilities under Danish ethical and data processing laws.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steno Adhesive Study 1
- ClinicalTrials.gov ID
- NCT07767461
- Acronym / sponsor ID
- StenoAD1 / StenoAD1
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Study start
- 4 Sep 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective study consisting of three in-person visits and two remote visits. Each participant will be enrolled in the study for a total of 6 months.
| Arm | Type | Receives |
|---|---|---|
| Hydrocolloid patch as patch used in the Sandwitch method | Experimental | Other: hydrocolloid patch as patch used in the Sandwich method |
| Hypafix skin-sensitive patch as patch used in the Sandwitch method | Active comparator | Other: Silicone-based patch as patch used in the Sandwitch method |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- An type of contact dermatitis caused by an insulin pump or a continuous glucose monitor (CGM)
- Age between 2-18 years prior to inclusion
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydrocolloid patch as patch used in the Sandwich methodWe are testing the hydrocolloid patch called Weloa Sensipatch | Other | Hydrocolloid patch as patch used in the Sandwitch method |
| Silicone-based patch as patch used in the Sandwitch methodHypafix skin-sensitive patch as patch used in the Sandwitch method | Other | Hypafix skin-sensitive patch as patch used in the Sandwitch method |
Primary outcome
Recurrence of contact dermatitis
Time frame: Assessments will be performed at baseline, 3 months, and 6 months.
the binary outcome recurrence of contact dermatitis
1 secondary outcome
Time in days to recurrence of contact dermatitis
Time frame: Baseline to 6 months after.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: Undecided. We are still investigating the possibilities under Danish ethical and data processing laws.
Related trials for Contact Dermatitis
Enrolling by invitation
Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Prevention and Treatment With Airtime
Diaper Dermatitis
Not yet recruiting
Use of Silk Fibroin Dressings in Primary Total Hip Arthroplasty
Allergic Contact Dermatitis (ACD)
Recruiting
Glycyrrhetinic Acid and Acute Irritant Dermatitis
Irritant Contact Dermatitis
Not yet recruitingPhase 4
Reliability of Expired Allergens in Patch Testing: A Comparative Study With Non-Expired Series
Allergic Contact Dermatitis
Recruiting
Helichrysum Italicum Extract in Irritant Contact Dermatitis
Skin Barrier Disruption and Recovery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fiona Marie W Sorensen, MD contact
Jannet Svensson, Professor study chair
Steno Diabetes Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hydrocolloid patch as patch used in the Sandwich method and Silicone-based patch as patch used in the Sandwitch method in people with Contact Dermatitis and Type 1 Diabetes Mellitus, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna K Berg, MD, PhD (+45 22 39 35 90, anna.korsgaard.berg@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of contact dermatitis (time frame: Assessments will be performed at baseline, 3 months, and 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.