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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Skin Abnormalities; Diabetes (Insulin-requiring, Type 1 or Type 2)

• Study Type: Observational
• Enrollment (Estimated): 199

Contacts and Locations

• Study Contact: Name: 晓春 陈, bachelor; Phone Number: +86 13857128162; Email: cxcsp2008@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: May 28, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Skin Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Skin and Connective Tissue Diseases; Diabetes Mellitus; Skin Abnormalities
• Other Study ID Numbers: 2025-IRB-0077-P-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No