Prevention of Skin Problems With Diabetes Devices in Pediatric Patients
A Prospective Study of Dermatological Complications Associated With Continuous Subcutaneous Insulin Infusion and/or Continuous Glucose Monitoring in Pediatric Patients With Type 1 Diabetes
1 other identifier
interventional
236
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2020
CompletedFirst Posted
Study publicly available on registry
February 6, 2020
CompletedStudy Start
First participant enrolled
March 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedDecember 7, 2022
December 1, 2022
2.5 years
January 28, 2020
December 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Trans Epidermal Water Loss (TEWL):
Up to 12 months after inclusion
Study Arms (2)
Intervention
EXPERIMENTALSkin Care Program
Control
NO INTERVENTIONUsual Treatment
Interventions
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.
Eligibility Criteria
You may qualify if:
- Diagnosed with Type 1 Diabetes
- Initiating either Insulin pump, Flash glucose monitorer or continuous glucose monitor
You may not qualify if:
- \*Language difficulties regarding Danish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Pediatrics, Herlev Hospital
Herlev, 2730, Denmark
Related Publications (1)
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.
PMID: 37279034DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jannet Svensson
Department of Pediatrics, Herlev and Gentofte Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, Assistant Professor
Study Record Dates
First Submitted
January 28, 2020
First Posted
February 6, 2020
Study Start
March 10, 2020
Primary Completion
September 20, 2022
Study Completion
November 30, 2022
Last Updated
December 7, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share