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Not yet recruitingNCT07615803Updated May 29, 2026

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

An observational study in Diabetes (Insulin-requiring, Type 1 or Type 2) and Skin Abnormalities, sponsored by The Children's Hospital of Zhejiang University School of Medicine. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-05-29.

Sponsored by The Children's Hospital of Zhejiang University School of Medicine · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
199
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes (Insulin-requiring, Type 1 or Type 2)
  • Skin Abnormalities
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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

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

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.
04

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
199 participants (estimated)
Patient registry
No
05

What researchers measure

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.

    Time frame: 2026.07-2027.06

06

Study locations

No study locations are listed for this record.

07

References and documents

Study documents

  • Protocol, analysis plan and consent form · Apr 30, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT07615803
Lead sponsor
The Children's Hospital of Zhejiang University School of Medicine
Responsible party
Sponsor
First posted
May 29, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Jul 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
May 29, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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