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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database

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The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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Postmarket Surveillance


 
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General
Study Status Delayed
522 Number / Requirement Number PS210001 / PSS001
Date Original Plan Accepted 05/25/2021
Date Current Plan Accepted 01/20/2023
Study Name Postmarket Surveillance
Device Name Freestyle libre 2 flash glucose monitoring system
Root Document Number K193371 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs
Detailed Study Protocol Parameters
Study Objectives This is a prospective, multi-center, non-randomized, single-arm study intended to characterize the safety of self- monitoring of blood glucose (SMBG) when used to manage diabetes in pediatric patients.


Study Population Pediatric subjects aged 4-17 years of age with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes. At least 50% of the study population will be age 4- 12 years of age.
Sample Size Approximately 400 subjects will be enrolled to obtain at least 314 subjects who complete the final visit.
Key Study Endpoints Primary Endpoint: The 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 both studies.

Secondary Endpoints:
• Incidence rate of severe hyperglycemic occurrences (with or without diabetic ketoacidosis or hyperglycemic hyperosmolar nonketotic syndrome) requiring health care professional (HCP) intervention including EMT assistance, hospital/clinic visit and/or hospitalization
during both studies.
• Device utilization metrics (SMBG frequency and sensor scan frequency)
• Quality of Life measures (Diabetes Treatment Satisfaction Questionnaires)
• Change in HbA1C
Follow-up Visits and Length of Follow-up Abbott Diabetes Care anticipates completing enrollment for Study 1 (SMBG) by August 18, 2022 and completing enrollment for Study 2 by February 18, 2023. ADC anticipates completing follow-up of all study subjects in Study 1 by February 18, 2023 and follow-up of all study subjects in Study 2 by August 18, 2023. ADC anticipates a follow-up rate of 80%.

Length of Follow-up Subjects will be in the study for one year.
Interim or Final Data Summary
Actual Number of Patients Enrolled 62 subjects enrolled in the control phase study and 51 subjects enrolled in the intervention phase study. 25 of the 51 subjects from the control phase transitioned to intervention phase study.
Actual Number of Sites Enrolled 8 clinical sites had initiated enrollment in the control phase study. At the time of this 24-month interim report, no sites remain active in the control phase study and 10 sites are currently active in the intervention phase study.
Patient Followup Rate Thirty-Seven (37) subjects were lost to follow-up. In all these cases, the subject either did not show up to a study visit and/or became unreachable. Multiple attempts, including phone calls, emails, and text messages, were made to locate each subject with no success. Additional subjects will be enrolled to the intervention phase study if the subjects lost to follow up exceed the protocol’s allowed percentage (up to 20%).
Final Safety Findings In the SMBG control phase data, 3 subjects had severe hypoglycemia (observed in 3 events) and 9 subjects had moderate hypoglycemia (observed in 16 events). For those enrolled directly into the intervention phase based on the historical medical records, 1 subject had severe hypoglycemia (observed in 2 events) and 2 subjects had moderate hypoglycemia (observed in 3 events) based on 6 months of medical record data. In the intervention phase data, 1 subject had severe hypoglycemia (observed in 2 events) and no subjects had moderate hypoglycemia (not observed in any events). In the SMBG control phase data, 3 subjects had severe hyperglycemia (observed in 4 events) that required healthcare professional intervention. For those enrolled directly into the intervention phase, 6 subjects had severe hyperglycemia (observed in 8 events) that required healthcare professional intervention based on 6 months of medical record data. In the intervention phase data, 1 subject had severe hypoglycemia (observed in 2 events) that required healthcare professional intervention.
Final Effectiveness Findings N/A (study has not progressed far enough to obtain findings)


Postmarket Surveillance Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 11/23/2021 11/17/2021 On Time
12 month report 05/25/2022 05/24/2022 On Time
18 month report 11/23/2022 11/22/2022 On Time
24 month report 05/25/2023 05/24/2023 On Time
30 month report 11/25/2023 11/21/2023 On Time
36 month report 05/25/2024    


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