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Why do insulin shots leave marks? new study investigates skin complications in kids with diabetes

NCT ID NCT07615803

Knowledge-focused Sponsor: The Children's Hospital of Zhejiang University School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at 199 children with type 1 diabetes who have been using insulin for at least 6 months. Researchers will check for skin problems like lumps under the skin (lipohypertrophy) caused by injections. They will also measure fat thickness with ultrasound and ask caregivers about their injection habits. The goal is to find out what factors lead to these skin complications, without giving any new treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 199 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Skin Abnormalities skin disorder type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes (insulin-requiring, type 1 or type 2) Skin abnormalities

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.