Type 1 DiabetesNCT04258904
Prevention of Skin Problems With Diabetes Devices in Pediatric Patients
A study testing Skin Care Program in people with Type 1 Diabetes and Dermatologic Complication, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial summary
A Cluster-controlled Intervention Trial regarding Prevention of Dermatological Complications towards use of Continuous glucose monitoring and insulin pumps in pediatric patients with Type 1 Diabetes. The patients will be followed prospectively with visits every 3rd month for the first year of initiation of device. Read more about this study
- Who is it for?
- Ages 2 to 20 years
- Conditions the study is for
- Type 1 Diabetes, Dermatologic Complication
- What is being tested?
- Skin Care Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Mar 2020to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with Type 1 Diabetes
- Initiating either Insulin pump, Flash glucose monitorer or continuous glucose monitor
Who cannot join
- Language difficulties regarding Danish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study of Dermatological Complications Associated With Continuous Subcutaneous Insulin Infusion and/or Continuous Glucose Monitoring in Pediatric Patients With Type 1 Diabetes
A Cluster-controlled Intervention Trial regarding Prevention of Dermatological Complications towards use of Continuous glucose monitoring and insulin pumps in pediatric patients with Type 1 Diabetes. The patients will be followed prospectively with visits every 3rd month for the first year of initiation of device. Besides a standardized treatment plan if dermatological complications evolve, will be used.
Read the detailed description
Background Unfortunately it has been shown earlier that dermatological complications are a huge challenge towards treatment with CSII and CGM in children. A preceding cross-sectional study in Danish patients showed that 90% of the 143 pediatric patients using CSII had experienced dermatological complications. Of those more than 60% currently had visible skin reaction due to the CSII. Dermatological complications to CSII were associated to atopic diseases and use of pump treatment for a longer period. For patients using CGM, 80% reported dermatological complications to the treatment, the most frequent being itching affecting more than 70%. Furthermore, 46% had at least one site with skin reaction due to CGM.
In the future, the use of artificial pancreas with closed-loop systems will still be dependent on the use of patches to fasten infu-sion sets and sensors. This skin complications poses a major challenge that must be investigated to reduce the overall burden of this chronic disease. The investigators have conducted a focus group study, which has given new insight into the perception of dermatological complications and further in-depth understanding of potential disease mechanisms regarding development of dermatological complications. No studies exist relating to prevention, consequences and treatment of dermatological complications in the setting of adhesive systems in T1D treatment.
Risk factors for development of dermatological complications are not well-known yet. Therefore, the investigators aim to create a possibly preventive screening tool based on a prospective study to guide future clinicians in whom patients are in risk of dermatological complications during use of CSII and CGM. This could help in guidance of which patients to give more information, preventive treatment or a more skin-sensitive CSII/CGM-system.
The hypothesis is that intensive information and proper skin care prior and during the initiation of CSII and CGM use, can reduce the dermatological
Study design This study is a prospective longitudinal study and will be the first longitudinal study concerning dermato-logical complications in a T1D population. It is a trial based on experience from pre-ceding cross-sectional study. The study is also a cluster-controlled intervention trial and will be the first interventional study regarding dermatological complications too. The intervention consists of intensive information about dermatological complications and possible preventive actions with skin moisturizing use. The cluster-controlling will include clusters defined by all patients from same de-partment. Patients enrolled from Herlev and Gentofte University Hospital will constitute the intervention group. Besides, a subgroup of the intervention group will be randomized to the ultrasound-skin-sites-intervention.
Justification for study design:
Dermatological complications construct a major challenge in diabetes technology especially among children and adolescents. To identify the modifiable or non-modifiable risk factors a prospective longitudinal study-design must be carried out. The longitudinal study-design will be combined with the interventional study to make the most of participants effort since the participants anyway will be investigated the first 12 months of their use of CSII and/or CGM/FGM. The interventional design could give important information regarding the possible effects of proper information and support regarding dermatological skin care and complications. And hopefully this could be a cheap way to reduce the dermatological complications.
- Conditions
- Type 1 Diabetes, Dermatologic Complication
- Being tested
- Skin Care Program
- Keywords
- Type 1 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Care ProgramCombination product
The intervention consists of a Skin Care Program including neat information regarding dermatological complications to the device use, prevention of these and moisturizer to keep healthy skin.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Skin Care Program Receives: Combination Product: Skin Care Program |
| Control | No intervention | Usual Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dermatological complications
Dermatological complications towards the devices will be assessed by clinical examination made by the investigator at visits every 3rd month and using a standardized scheme combined with self-reporting from the patients through diary forms if dermatological complications arise between visits. The incidence of dermatological complications through the time frame will be reported as primary outcome.
Measured: Up to 12 months after inclusion
Secondary outcomes (1)
Trans Epidermal Water Loss (TEWL):
TEWL value is a good measure of the leaky properties of the skin (the water evaporation rate). It is measured by Aquaflux AF2000 from Biox Systems
Measured: Up to 12 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start10 Mar 2020
- Primary completion20 Sep 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jannet Svensson, Copenhagen University Hospital at Herlev
- Investigators
- Jannet Svensson, Principal investigator, Department of Pediatrics, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258904
- Sponsor's protocol ID
- SkinProsp_29042019_v6
- Status last verified
- Dec 2022
- First submitted
- 28 Jan 2020
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sorensen FMW, Svensson J, Kinnander C, Berg AK. Ultrasound Detected Subcutaneous Changes in a Pediatric Cohort After Initiation of a New Insulin Pump or Glucose Sensor. Diabetes Technol Ther. 2023 Sep;25(9):622-630. doi: 10.1089/dia.2023.0137. Epub 2023 Jun 6.
PubMed 37279034
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Dermatological Complications Associated With Continuous Subcutaneous Insulin Infusion and/or Continuous Glucose Monitoring in Pediatric Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04258904
- Acronym / sponsor ID
- SkinProsp_29042019_v6
- Conditions
- Type 1 Diabetes, Dermatologic Complication
- Keywords
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 6 Feb 2020 (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.
A Cluster-controlled Intervention Trial regarding Prevention of Dermatological Complications towards use of Continuous glucose monitoring and insulin pumps in pediatric patients with Type 1 Diabetes. The patients will be followed prospectively with visits every 3rd month for the first year of initiation of device. Besides a standardized treatment plan if dermatological complications evolve, will be used.
Detailed description
Background Unfortunately it has been shown earlier that dermatological complications are a huge challenge towards treatment with CSII and CGM in children. A preceding cross-sectional study in Danish patients showed that 90% of the 143 pediatric patients using CSII had experienced dermatological complications. Of those more than 60% currently had visible skin reaction due to the CSII. Dermatological complications to CSII were associated to atopic diseases and use of pump treatment for a longer period. For patients using CGM, 80% reported dermatological complications to the treatment, the most frequent being itching affecting more than 70%. Furthermore, 46% had at least one site with skin reaction due to CGM.
In the future, the use of artificial pancreas with closed-loop systems will still be dependent on the use of patches to fasten infu-sion sets and sensors. This skin complications poses a major challenge that must be investigated to reduce the overall burden of this chronic disease. The investigators have conducted a focus group study, which has given new insight into the perception of dermatological complications and further in-depth understanding of potential disease mechanisms regarding development of dermatological complications. No studies exist relating to prevention, consequences and treatment of dermatological complications in the setting of adhesive systems in T1D treatment.
Risk factors for development of dermatological complications are not well-known yet. Therefore, the investigators aim to create a possibly preventive screening tool based on a prospective study to guide future clinicians in whom patients are in risk of dermatological complications during use of CSII and CGM. This could help in guidance of which patients to give more information, preventive treatment or a more skin-sensitive CSII/CGM-system.
The hypothesis is that intensive information and proper skin care prior and during the initiation of CSII and CGM use, can reduce the dermatological
Study design This study is a prospective longitudinal study and will be the first longitudinal study concerning dermato-logical complications in a T1D population. It is a trial based on experience from pre-ceding cross-sectional study. The study is also a cluster-controlled intervention trial and will be the first interventional study regarding dermatological complications too. The intervention consists of intensive information about dermatological complications and possible preventive actions with skin moisturizing use. The cluster-controlling will include clusters defined by all patients from same de-partment. Patients enrolled from Herlev and Gentofte University Hospital will constitute the intervention group. Besides, a subgroup of the intervention group will be randomized to the ultrasound-skin-sites-intervention.
Justification for study design:
Dermatological complications construct a major challenge in diabetes technology especially among children and adolescents. To identify the modifiable or non-modifiable risk factors a prospective longitudinal study-design must be carried out. The longitudinal study-design will be combined with the interventional study to make the most of participants effort since the participants anyway will be investigated the first 12 months of their use of CSII and/or CGM/FGM. The interventional design could give important information regarding the possible effects of proper information and support regarding dermatological skin care and complications. And hopefully this could be a cheap way to reduce the dermatological complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Combination Product: Skin Care ProgramSkin Care Program |
| Control | No intervention | –Usual Treatment |
Who may qualify
- Ages
- 2 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Diagnosed with Type 1 Diabetes
- Initiating either Insulin pump, Flash glucose monitorer or continuous glucose monitor
Key exclusion criteria (1 listed)
- Language difficulties regarding Danish
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 |
|---|---|---|
| Skin Care ProgramThe intervention consists of a Skin Care Program including neat information regarding dermatological complications to the device use, prevention of these and moisturizer to keep healthy skin. | Combination product | Intervention |
Primary outcome
Incidence of dermatological complications
Time frame: Up to 12 months after inclusion
Dermatological complications towards the devices will be assessed by clinical examination made by the investigator at visits every 3rd month and using a standardized scheme combined with self-reporting from the patients through diary forms if dermatological complications arise between visits. The incidence of dermatological complications through the time frame will be reported as primary outcome.
1 secondary outcome
Trans Epidermal Water Loss (TEWL):
Time frame: Up to 12 months after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Derived from this study: PubMed 37279034Sorensen FMW, Svensson J, Kinnander C, Berg AK. Ultrasound Detected Subcutaneous Changes in a Pediatric Cohort After Initiation of a New Insulin Pump or Glucose Sensor. Diabetes Technol Ther. 2023 Sep;25(9):622-630. doi: 10.1089/dia.2023.0137. Epub 2023 Jun 6.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jannet Svensson principal investigator
Department of Pediatrics, Herlev and Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin Care Program in people with Type 1 Diabetes and Dermatologic Complication, run by Copenhagen University Hospital at Herlev 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 1 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: finished, as of the sponsor's last update on 7 Dec 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dermatological complications (time frame: Up to 12 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04258904, which also lists 1 linked publication.
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 7 Dec 2022.