beta
Trial Radar AI
One study matched filter criteria
Card View
Back to Search

Prevention of Skin Problems With Diabetes Devices in Pediatric Patients 236 Pediatric Prevention

Completed
Clinical Trial NCT04258904 was an interventional study for Type 1 Diabetes, Dermatologic Complication that is now completed. The study started on March 10, 2020, with plans to enroll 236 participants. Led by Copenhagen University Hospital at Herlev, the expected completion date was November 30, 2022. The latest data from ClinicalTrials.gov was last updated on December 7, 2022.
Brief 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. 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 C...Show More
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

Conditions
Type 1 DiabetesDermatologic Complication
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • SkinProsp_29042019_v6
NCT ID Number
NCT04258904
Start Date (Actual)
2020-03-10
Last Update Posted
2022-12-07
Completion Date (Estimated)
2022-11-30
Enrollment (Estimated)
236
Study Type
Interventional
PHASE
N/A
Status
Completed
Keywords
Type 1 Diabetes
Primary Purpose
Prevention
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalIntervention
Skin Care Program
Skin Care Program
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.
No InterventionControl
Usual Treatment
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
Up to 12 months after inclusion
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Up to 12 months after inclusion
Eligibility Criteria

Eligible Ages
Child, Adult
Minimum Age
2 Years
Eligible Sexes
All
  • Diagnosed with Type 1 Diabetes
  • Initiating either Insulin pump, Flash glucose monitorer or continuous glucose monitor

*Language difficulties regarding Danish
Copenhagen University Hospital at Herlev logoCopenhagen University Hospital at Herlev
Study Responsible Party
Jannet Svensson, Principal Investigator, MD, PhD, Assistant Professor, Copenhagen University Hospital at Herlev
No contact data.
1 Study Locations in 1 Countries
Department of Pediatrics, Herlev Hospital, Herlev, 2730, Denmark