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|
| General |
| Study Status |
Progress Inadequate |
| Application Number |
P160030 / PAS001 |
| Date Current Protocol Accepted |
01/19/2022
|
| Study Name |
FreeStyle Libre Flash Glucose Monitoring
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent A (distinctively) : 18-21 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Design Description |
This is a prospective, multi-center, nonrandomized, single-arm, post-approval study of the FreeStyle Libre 2 Flash CGM intended to characterize the safety of the device when used to manage diabetes in young adult 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 during each phase. Assessment of
adverse events will occur via self-reporting at each monthly visit and/or phone call. Subjects will also complete a Quality of Life questionnaires (DTSQs and DTSQc).
|
| Study Population Description |
Young adult subjects aged 18-30 years with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manager their diabetes.
|
| Sample Size |
Up to approximately 150 subjects will be enrolled to obtain at least 118 subjects who complete the final visit.
|
| Data Collection |
Primary Endpoints: 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 the study. Relative risk of severe and moderate hypoglycemia associated with FSL2 use from this study and SMBG use.
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 the study. Relative risk of severe hyperglycemic events associated with FSL2 use from this study and SMBG use. Sensor scan frequency, quality of life measures, and change in HbA1c.
|
| Follow-up Visits and Length of Follow-up |
Approximately six months per subject. Approximately three years for study execution and completion.
|
| Interim or Final Data Summary |
| Interim Safety Information |
N/A
|
| Actual Number of Patients Enrolled |
As of April 25, 2022, no subjects of ages 18-30 have been enrolled in
the study.
|
| Actual Number of Sites Enrolled |
4
|
| Patient Follow-up Rate |
N/A
|
