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NCT07615803Not yet recruiting

Study on Influencing Factors of Skin Complications Related to Insulin Injection in Children With Type 1 Diabetes Mellitus

Source: ClinicalTrials.gov · Last updated 29 May 2026

Brief summary (registry, in English)

This study was a cross-sectional, observational design without involving random grouping or intervention. From July 2026 to June 2027, 199 children with type 1 diabetes who had received insulin treatment for at least 6 months and their main family caregivers were recruited by a continuous enrollment method from the endocrinology department of a tertiary children's hospital in Zhejiang Province. Qualified investigators conducted on-site distribution and collection of structured questionnaires, collecting general information of the children, the occurrence of skin complications, and the insulin injection behaviors of the caregivers. At the same time, personnel with ultrasound qualifications used a wireless handheld ultrasound combined with a skin lipid caliper to uniformly measure the subcutaneous fat thickness at 8 sites including the abdomen, buttocks, arms, and thighs.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
199 (estimated)
First submitted
30 Apr 2026
Start date
1 Dec 2026
Primary completion date
1 Jul 2027
Lead sponsor
The Children's Hospital of Zhejiang University School of Medicine
NCT number
NCT07615803

What you commit to

  • Study type: Observational
  • Planned participants: 199
  • From 1 Dec 2026 to the primary completion date, 1 Jul 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patient has acute or chronic complications of diabetes and is unable to cooperate, requiring urgent treatment.
  • Patient is in a state of disease stress, such as acute infection, surgery, trauma, etc., and is difficult to cooperate with the research.
  • Patient's family caregiver has hearing or language disorders.

Other

  • Patient's family caregiver has unconsciousness or abnormal mental state.
  • Patient or patient's family caregiver has already participated in this survey.

Who the study is looking for

  • Patient meets the diagnostic criteria for T1DM recommended by WHO and is diagnosed with T1DM.
  • Patient was diagnosed with T1DM for \>= 6 months.
  • Patient has no cognitive or awareness disorders and has the ability to read.
  • Patient agrees to participate in this study.
  • Patient's family caregiver has a certain level of comprehension ability, is conscious and clear-minded during the survey, and can answer freely.
  • Patient's family caregiver voluntarily participates in the survey.
  • Patient's family caregiver provides an average daily care time for the child of \>= 6 hours.

Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.