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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07615803
Enrollment
199
Registered
2026-05-29
Start date
2026-12-01
Completion date
2027-12-01
Last updated
2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Sponsors

The Children's Hospital of Zhejiang University School of Medicine
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of insulin injection-related lipohypertrophy2026.07-2027.06The 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.

Contacts

CONTACT晓春 陈, bachelor
cxcsp2008@zju.edu.cn+86 13857128162

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026