FSL2 Post Approval Study for Pediatric and Young Adults Patients

  • STATUS
    Recruiting
  • participants needed
    550
  • sponsor
    Abbott Diabetes Care
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Updated on 20 March 2026
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Summary

This is a prospective, multi-center, non-randomized, single-arm study intended to characterize the safety of the FreeStyle Libre 2 Flash Glucose Monitoring System when used to manage diabetes in pediatric and young adult patient populations.

Description

Approximately 550 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 will be enrolled in the study. Subjects and/or their caregivers will utilize he FreeStyle Libre 2 Flash Glucose Monitoring System for managing diabetes for 6 months. Subjects and/or their caregivers will maintain a diary/log book of Adverse Events experienced during the duration of the study. Assessment of Adverse Events will occur via self reporting at each monthly visit and/or phone call.

Details
Condition Diabete Mellitus
Age 4years - 30years
Clinical Study IdentifierNCT04959552
SponsorAbbott Diabetes Care
Last Modified on20 March 2026

Eligibility

 Yes No Not Sure

Inclusion Criteria

Subject must be 4 - 30 years of age
Subject must have a diagnosis of type 1 or type 2 diabetes mellitus for at least 3 months prior to enrollment
Subject is currently using Self Monitoring of Blood Glucose (SMBG) for managing their diabetes
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
Subject and/or caregiver must be able to read and understand English
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
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

Subject has previously used a continuous glucose monitoring system to manage their diabetes within the last six (6) months
Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin
Subject is known to be pregnant or is attempting to become pregnant at the time of enrollment
Subject is on dialysis at the time of enrollment
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
Subject currently is participating in another clinical trial
Subject is unsuitable for participation due to any other cause as determined by the Investigator
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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