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Active, not recruitingNCT04959552Updated Apr 9, 2026

FSL2 Post Approval Study for Pediatric and Young Adults Patients

An observational study in Diabete Mellitus, sponsored by Abbott Diabetes Care. Active, not recruiting at 3 sites in United States. Open to participants aged 4 Years to 30 Years. Per ClinicalTrials.gov, last updated 2026-04-09.

Sponsored by Abbott Diabetes Care (part of Abbott) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
550
Ages
4 Years to 30 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Diabete Mellitus

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03

In context

Diabetes Mellitus

8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.

This study's planned enrollment of 550 is above the median of 246 across 1,936 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Abbott Diabetes Care is the lead sponsor of 43 studies on the registry; 3 are open to participants now.

Browse Abbott Diabetes Care studies →All Abbott studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 and assent when appropriate.

Exclusion criteria

Exclusion Criteria:

  1. Subject has previously used a continuous glucose monitoring system to manage their diabetes within the last six (6) months.
  2. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
  3. Subject is known to be pregnant or is attempting to become pregnant at the time of enrollment.
  4. Subject is on dialysis at the time of enrollment.
  5. 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.
  6. Subject currently is participating in another clinical trial.
  7. Subject is unsuitable for participation due to any other cause as determined by the Investigator.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
550 participants (estimated)
Patient registry
No

Interventions

  • DeviceFreeStyle Libre 2

    The FreeStyle Libre 2 Flash Glucose Monitoring

06

What researchers measure

Primary outcomes

  1. Characterize the safety of the FreeStyle Libre 2 Flash Glucose Monitoring System when used to manage diabetes in pediatric and young adult patient populations

    Incidence rate of severe hypoglycemic occurrences requiring health care professional (HCP) intervention including EMT assistance, hospital/clinic visit and/or hospitalization and moderate hypoglycemia in which the patient required the assistance of another person (e.g. as a result of confusion, coma, or seizure) during the study will be collected. The incidence rate of severe hypoglycemia associated with FSL2 use from this study will be compared with the incidence rate observed from self-monitoring blood glucose (SMBG) use observed during the prior 6 months.

    Time frame: Six Months

07

Study locations

3 sites
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04959552
Lead sponsor
Abbott Diabetes Care
Responsible party
Sponsor
First posted
Jul 13, 2021
Start date
Jun 1, 2021
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Apr 9, 2026

Study contacts

Shridhara Karinka, PhD
study director · Abbott Diabetes Care

Oversight

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

Not currently enrolling

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

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Discussion

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