The Skin Barrier in Users of Diabetes Devices

NCT06856954 | Recruiting

• 1 other identifier: StenoLinskinstudy
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes technology (insulin pumps and continuous glucose monitoring) have become standard of care in children with type 1 diabetes. Unfortunately, the attachment of the devices to the skin can provoke injury, irritative or allergic eczema of the skin. Additionally, the continuous insulin infusion often causes sub-cutaneous lipohypertrophy. These occurrences are likely to increase blood glucose fluctuation and impact burden of diabetes. In collaboration with dermatologists, the propose is to investigate the skin microcirculation and skin barrier as well as the subcutaneous tissue when exposed to insulin, occlusion, irritative and allergenic features of the part of device in close contact with the skin. Secondly, investigate the skin barrier and recovery time as a function of time since exposure, type of patches/device and use of preventive strategies like steroids, liquid barrier crème or local anesthetic. To study microcirculation the investgators use Tissue Viability Imaging (TiVI) a non-invasive method using polarization light spectroscopy to count red blood cells thereby saying something about the microcirculation. To investigate skin barrier, the investigators use electric impedance spectroscopy (EIS) which is a non-invasive method sending small electric current of different frequencies through the skin surface. The different frequencies have different properties regarding penetration of cells making it possible to measure the resistance towards each frequency. In this way give a measure of the skin barrier. The last methods investigators are using is ultrasound a non-invasive method that uses sound to show different structures in the subcutaneous tissue, it has been demonstrated to be better than visual inspection to detect lipohypertrophy in the subcutaneous tissue. Lipohypertrophy is often seen in places with repeated infusion/injection of insulin. These investigations are necessary to motivate and guide the development of new materials for diabetes devices and provide clinical guidelines regarding device position and site rotation in order to prevent skin complications from interfering with optimal treatment. This could lead to improved short and long-term outcome in the care of persons with diabetes.

Conditions

Type 1 Diabetes Mellitus

Keywords

eczema; lipodystrophy; children; diabetes technology; continous glucose monitor; insulin pump; electric impedance; inflammation

Outcome Measures

Primary Outcomes (1)

• electric impedance spectroscopy (EIS)

  Electric impedance spectroscopy (EIS) of the skin at last positions of device measured by Nevisense

  At enrollment and 4 months later at next scheduled ordinary visit

Secondary Outcomes (10)

• Tissue Viability Imaging (TiVI)

  At enrollment and 4 months later at next scheduled ordinary visit

• hyperechogenicity or hypoechogenicity

  At enrollment and 4 months later at next scheduled ordinary visit

• Time-in-target (TIT: 3.9 - 8 mmol/l)

  At enrollment and 4 months later at next scheduled ordinary visit

• time-below-range (TBR: < 3.9 mmol/l)

  At enrollment and 4 months later at next scheduled ordinary visit

• HbA1c

  At enrollment and 4 months later at next scheduled ordinary visit

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children between 2 and 17 years of age followed with type 1 diabetes at Crown Princess Victoria Children´s Hospital, Linköping Sweden

You may qualify if:

• diagnosed with type 1 diabetes
• using diabetes device attached to the skin (insulin pump or CGM)

You may not qualify if:

• Do not use diabetes device attached to the skin.
• Those unable to read and understand Swedish or English
• impaired cognitive development that may interfere with the ability to answer questionnaires in Swedish/English and/or be reached by phone.

Sponsors & Collaborators

• Jannet Svensson: lead
• Linkoeping University: collaborator

Study Sites (1)

Crown Princess Victoria Children´s Hospital

Linköping, 58185, Sweden

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Eczema; Lipodystrophy; Inflammation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Skin Diseases, Metabolic; Lipid Metabolism Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jannet Svensson, PhD

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jannet Svensson, PhD

CONTACT

+45 25488355; jannet.svensson.01@regionh.dk

Pär A White, MD, PhD

CONTACT

+46 701760188; par.andersson.white@regionostergotland.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: March 10, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-03

Locations

SE (1)