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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Diabetes (Insulin-requiring, Type 1 or Type 2) Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Skin Abnormalities Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Prevalence of insulin injection-related lipohypertrophy

Time frame: 2026.07-2027.06

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.

Study contacts

Contact information is provided by the study sponsor or research team.

晓春陈, bachelor

CONTACT

[email protected]

+86 13857128162

Sponsors and collaborators

Lead sponsor

The Children's Hospital of Zhejiang University School of Medicine

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: May 29, 2026
Registry last updated: May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting