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| General |
| Study Status |
Delayed |
| 522 Number / Requirement Number |
PS210001 / PSS001 |
| Date Original Plan Accepted |
05/25/2021
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| Date Current Plan Accepted |
01/20/2023
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| Study Name |
Postmarket Surveillance
|
| Device Name |
Freestyle libre 2 flash glucose monitoring system
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| Root Document Number |
K193371
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Historical Control
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| Analysis Type |
Analytical
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| Study Population |
Child: 2-12 yrs,
Adolescent: 13-18 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
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 (includes FreeStyle Libre 2 Sensor and FreeStyle Libre 2 Plus Sensor) and FreeStyle Libre 3 CGM System (includes FreeStyle Libre 3 Sensor and FreeStyle Libre 3 Plus Sensor) when used to manage diabetes in pediatric patients.
|
| Study Population |
Pediatric subjects aged 2-17 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 2- 12 years of age.
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| Sample Size |
Approximately 400 subjects will be enrolled to obtain at least 314 subjects who complete the final visit.
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| 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 (sensor scan frequency)
• Quality of Life measures (Diabetes Treatment Satisfaction Questionnaires)
• Change in HbA1C
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| Follow-up Visits and Length of Follow-up |
Abbott Diabetes Care anticipates completing enrollment by February 18, 2023. ADC anticipates a follow-up rate of 80%.
Length of Follow-up Subjects will be in the study for one year.
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| 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.
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| 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.
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| 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%).
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| 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.
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| Final Effectiveness Findings |
N/A (study has not progressed far enough to obtain findings)
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