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New glucose monitor aims to prevent dangerous low blood sugar in kids

NCT ID NCT04959552

Disease control Sponsor: Abbott Diabetes Care Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is testing the safety of the FreeStyle Libre 2, a device that continuously checks blood sugar levels, in 550 children and young adults aged 4 to 30 with type 1 or type 2 diabetes. The goal is to see if using this monitor reduces severe low blood sugar events that need medical help, compared to standard finger-prick testing. Participants wear the sensor and continue their usual diabetes care.

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 550 people

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

Started

Jun 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Pediatric and young adult subjects aged 4-30 years with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes. Approximately 35% of the study population will be age 4-12 years of age, and approximately 30% of the study population will be age 18-30 years of age.

Ages

4 to 30 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. Subject must be 4 - 30 years of age. 2. Subject must have a diagnosis of type 1 or type 2 diabetes mellitus for at least 3 months prior to enrollment. 3. Subject is currently using Self Monitoring of Blood Glucose (SMBG) for managing their diabetes. 4. Subject has completed participation in clinical study ADC-US-PMS-20194 or has at least six (6) months of medical history hypoglycemia or hyperglycemia requiring healthcare professional intervention. 5. Subject and/or caregiver must be able to read and understand English. 6. In the investigator's opinion, the subject and/or caregiver must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol. 7. Subject and/or parent or guardian must be willing and able to provide written signed and dated informed consent and assent when appropriate. Exclusion Criteria: 8. Subject has previously used a continuous glucose monitoring system to manage their diabetes within the last six (6) months. 9. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin. 10. Subject is known to be pregnant or is attempting to become pregnant at the time of enrollment. 11. Subject is on dialysis at the time of enrollment. 12. Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff. 13. Subject currently is participating in another clinical trial. 14. Subject is unsuitable for participation due to any other cause as determined by the Investigator.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus type 1 diabetes mellitus type 2 diabetes mellitus

As listed by the trial registrant

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

Diabete mellitus

Contacts and locations

Locations

  • The Children's Mercy Hospital

    Kansas City, Missouri, 64108, United States

  • The DOCS

    Las Vegas, Nevada, 89113, United States

  • Yale Pediatric Endocrinology Clinic

    New Haven, Connecticut, 06511, United States

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