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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 |
Historical 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 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.
|
| 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 (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 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.
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results:
Hypoglycemia Events: 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, 2 subjects had severe hypoglycemia (observed in 3 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
2 subject had moderate hypoglycemia (observed in 2 events). This is
an increase in 1 severe hypoglycemic event (from 1 subject) as
compared to the snapshot taken at the 36 month report. As the total
number of subjects in the intervention phase has increased 124
subjects, the additional adverse event is not unexpected given the
increase in number of subjects enrolled.
Hyperglycemia 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, 10 subjects had severe hyperglycemia
(observed in 14 events) that required healthcare professional
intervention based on 6 months of medical record data. In the
intervention phase data, 4 subjects had severe hyperglycemia
(observed in 6 events) that required healthcare professional
intervention. This is an increase in 3 severe hyperglycemic event as
compared to the snapshot taken at the 36 month report. As the total
number of subjects has increased to 124 subjects, the additional
adverse event is not unexpected given the increase in subjects
enrolled in the intervention phase.
|
| Actual Number of Patients Enrolled |
ADC enrolled 62 subjects in the SMBG control phase study prior to approval of PS210001/S001, and 87 subjects are enrolled in the
intervention phase study at the time of this 42-month interim report.
|
| Actual Number of Sites Enrolled |
Eight clinical sites had initiated enrollment in the control phase study. At the time of this 42-month interim report, no sites remain
active in the control phase study and 10 sites are currently active in the intervention phase study. At the time of this report, three sites
were terminated with IRB. Children’s Mercy Endo Clinic (#101) was terminated with IRB on September 6, 2023, as this site was no
longer interested in participating in the study due to subject enrollment challenges. There were two additional sites (DOCS (#103) and Wake Forest Baptist Health Diabetes Clinic (#097) no longer interested in participating in the study due to subject enrollment challenges or staffing issues, and they were terminated with IRB on January 22, 2024, and February 20,2024, respectively. However, this report includes data collected from site 101 prior to its termination including data from two subjects who had enrolled in the intervention phase at this site. These two subjects have exited the study and neither completed the study per the intervention phase
protocol.
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| Patient Followup Rate |
Thirty-two (32) 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 Effectiveness Findings |
N/A (study has not progressed far enough to obtain findings)
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