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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 40 subjects enrolled in the intervention phase study.
|
| Actual Number of Sites Enrolled |
8 for control phase, 8 for the intervention phase.
|
| Patient Followup Rate |
19 subjects have been lost to follow-up in the control phase and 11 in the intervention phase
|
| Final Safety Findings |
In the SMBG control phase data, 3 subjects had severe hypoglycemia (observed in 3 events), 10 subjects (including one subject with 6 months historical medical record data) had moderate hypoglycemia (observed in 17 events). Five subjects in the SMBG control phase (including 2 subjects with medical record data) had severe hyperglycemia (observed in 6 events). No adverse events have been reported thus far for the intervention phase.
|
| Final Effectiveness Findings |
N/A (study has not progressed far enough to obtain findings)
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