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New devices aim to take the sting out of insulin injections for children

NCT ID NCT07239700

Symptom relief Sponsor: Hakkari Universitesi 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
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests two simple devices—Buzzy, which uses cold and vibration, and TickleFlex, a soft pen attachment—to see if they can reduce pain and fear during insulin injections in children aged 6 to 12 with type 1 diabetes. 90 children will be randomly assigned to use one of the devices or receive a standard injection. Pain and fear levels will be reported by the child, parent, and researcher right after the shot.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 90 people

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

Started

Jun 2025

Expected to finish

Dec 2025

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.

Ages

6 to 12 years

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: * Children aged 6 to 12 years. * Diagnosed with Type 1 Diabetes Mellitus (T1DM) for at least 6 months. * Receiving daily subcutaneous insulin injections as part of routine diabetes management. * Able to understand and communicate pain and fear levels using the Wong-Baker -FACES Pain Rating Scale and the Children's Fear Scale. * Accompanied by a parent or legal guardian who can provide informed consent. * Willingness of both the child and parent to participate in the study. * No visual, auditory, or cognitive impairments that would interfere with data collection. Exclusion Criteria: * Presence of neurological, sensory, or cognitive disorders that may affect pain or fear perception. * Peripheral neuropathy or other diabetic complications influencing pain sensation. * Use of analgesics, sedatives, or anxiolytic medications within 24 hours prior to data collection. * Local skin lesions, infections, or allergies at or near the insulin injection site. * History of needle phobia or severe anxiety disorders diagnosed by a healthcare professional. * Concurrent participation in another interventional clinical study. * Refusal or inability of the child or parent/guardian to provide written informed consent.

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Conditions

The condition(s) this trial relates to.

Pain type 1 diabetes mellitus

As listed by the trial registrant

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

Diabete type 1 Diabetes in children

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Hakkari University

    Hakkari, Centre, 65030, Turkey (Türkiye)

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