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

NCT07615803 | Not Yet Recruiting

• 1 other identifier: 2025-IRB-0077-P-01
• Study Type: observational
• Target: 199
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabetes (Insulin-requiring, Type 1 or Type 2); Skin Abnormalities

Outcome Measures

Primary Outcomes (1)

• Prevalence of insulin injection-related lipohypertrophy

  The proportion of children with type 1 diabetes who are identified as having insulin injection-related lipohypertrophy. Lipohypertrophy will be determined as present if it is detected by physical examination and/or ultrasound assessment; results from these assessments will be combined into a single yes/no determination for each participant and reported as a proportion.

  2026.07-2027.06

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Children diagnosed with type 1 diabetes and receiving insulin treatment, along with their primary family caregivers

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Children's Hospital of Zhejiang University School of Medicine: lead

MeSH Terms

Conditions

Diabetes Mellitus; Skin Abnormalities

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

晓春 陈, bachelor

CONTACT

+86 13857128162; cxcsp2008@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 29, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-02