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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 Study Pending
522 Number / Requirement Number PS210001 / PSS001
Date Current Plan Accepted  
Study Name Postmarket Surveillance
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 Design Description Study 1: 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.



Subjects and/or their caregivers will utilize capillary SMBG 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.



Subjects ages 13 and older and all caregivers will complete Quality of Life questionnaires.



Study 2: This is a prospective, multi-center, non-randomized, single-arm study intended to characterize the safety of self- monitoring of the FreeStyle Libre 2 Flash Glucose Monitoring System when used to manage diabetes in pediatric patients.



Subjects and/or their caregivers will utilize the 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.



Subjects ages 13 and older and all caregivers will complete Quality of Life questionnaires.



Subjects who complete Study 1 will be eligible to enroll in Study 2.

Study Population Description 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.
Data Collection 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.



Postmarket Surveillance Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 11/21/2021    
12 month report 05/20/2022    
18 month report 11/16/2022    


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