FSL2 Post Approval Study for Pediatric and Young Adults Patients

NCT04959552 | Active Not Recruiting FDA Device

• 1 other identifier: ADC-US-PMS-20196
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Diabete Mellitus

Outcome Measures

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.

  Six Months

Interventions

FreeStyle Libre 2 DEVICE

The FreeStyle Libre 2 Flash Glucose Monitoring

Eligibility Criteria

• Age: 4 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Diabetes Care: lead

Study Sites (3)

Yale Pediatric Endocrinology Clinic

New Haven, Connecticut, 06511, United States

Location

The Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

The DOCS

Las Vegas, Nevada, 89113, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Shridhara Karinka, PhD

  Abbott Diabetes Care

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Post-Marketing Study: Yes

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: July 13, 2021
• Study Start: June 1, 2021
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

US (3)