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临床试验/NCT06856954
NCT06856954招募中不适用

The Skin Barrier in Users of Diabetes Devices - Showing the Path to New Way to Prevent and Cure Skin Complications

Jannet Svensson1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年3月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
electric impedance spectroscopy (EIS)

研究概览

简要总结

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.

详细描述

1.2 What is the scientific purpose of the study?

The purpose of the study 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

1.3 These are the research questions

  1. Do instruction in rotation of insulin pump position using ultrasound improve insulin absorption measured as lower insulin need per kg.
  2. Are there detectable differences in measures of skin barrier and micro circulation and visible ultrasound findings comparing the most recent sites of application of devices with regard to material (product) and the attachment time.
  3. For how long after diabetes device removal are there visible or measurable changes in the cutaneous and subcutaneous environment of the skin, i.e. how long does the skin need to recover
  4. What is the impact on the cutaneous and subcutaneous environment of use of liquid barrier cremes, different patch type, glue removal, different steroid or local anesthetic products
  5. Is new device material (e.g. hydrocolloid, silicone or silicone /glycerol) able to impact frequency, extent or recovery time for skin barrier health

Background:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
2 Years 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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.

结局指标

主要结局

electric impedance spectroscopy (EIS)

时间窗: At enrollment and 4 months later at next scheduled ordinary visit

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

次要结局

  • 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)
  • Electric impedance spectroscopi (EIS)(At enrollment and 4 months later at next scheduled ordinary visit)
  • eczema(At enrollment and 4 months later at next scheduled ordinary visit)
  • wounds(At enrollment and 4 months later at next scheduled ordinary visit)
  • The strength and difficulties questionnaire (SDQ)(At enrollment and 4 months later at next scheduled ordinary visit)
  • Diabetes health-related Quality of Life (DISABKIDS)(At enrollment and 4 months later at next scheduled ordinary visit)

研究者

发起方
Jannet Svensson
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Jannet Svensson

Professor

Linkoeping University

研究点 (1)

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