|
|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P160048 S006/ PAS001 |
| Date Original Protocol Accepted |
11/25/2019
|
| Date Current Protocol Accepted |
05/04/2022
|
| Study Name |
Eversense CGM Non-Adjunctive PAS
|
| Device Name |
Eversense Continuous Glucose Monitoring System
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Device Subjects Serve as Own Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The purpose of this post-approval study (PAS) is to evaluate the safety of non-adjunctive use of the Senseonics Eversense and Eversense E3 Continuous Glucose Monitoring (CGM) Systems relative to the use of glucose meters. This is a one-year prospective cross-over study in which all subjects will use a glucose meter (SMBG arm) for a 6-month period followed by 6 months of using the Eversense CGM Systems (CGM arm).
|
| Study Population |
Subjects may be included in the PAS if they fit the following inclusion criteria:
1. Subject has diabetes
2. Subject is greater than or equal to 18 years of age
3. Subject has a smartphone that is internet enabled
4. Subject is able to comply with study protocol tasks and understand written and verbal instructions in the investigator’s opinion
5. Subjects is willing and able to provide written, signed and dated informed consent
Subjects may not be included in the PAS if they fulfill the following exclusion criteria:
1. Subject is critically ill or hospitalized
2. At least 4 weeks of continuous use of CGM experience in the last 12 months, and no more than 1 week of continuous use in the last 6 months
3. Subject has a known contraindication to dexamethasone or dexamethasone acetate
4. Subjects requiring intravenous mannitol or mannitol irrigation solutions
5. Subject is on dialysis at the time of enrollment
6. Female subjects who are pregnant, planning on becoming pregnant or nursing
|
| Sample Size |
Up to 925 subjects will be enrolled in the United States at up to 60 sites.
|
| Key Study Endpoints |
The primary safety endpoint is the rate of the composite of severe hypoglycemia and diabetic ketoacidosis.
Other safety endpoints include:
Rate of all device-related and insertion and removal procedure-related adverse events
Rate of adverse events related to use of the user interface, patient training, or labeling materials.
Change in HbA1c from baseline at 6 and 12 months
Average hours of use per day
Serious adverse events regardless of causality
|
| Follow-up Visits and Length of Follow-up |
Patients will participate for up to 12 months (6 months in each of two study arms)
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results
For Post-Approval Study (P160048): Three hundred thirty-four (334) adverse events (AE) have been reported as of the reporting period through April 10, 2023. Of these events, 93 are related to the study device and/or the insertion or removal procedure.
For Eversense CGM Non-Adjunctive PAS (P160048/S006): Seventy-three (73) adverse events (AE) have been reported as of the reporting period through April 10, 2023. Of these events, nineteen (19) are related to the study device and/or the insertion or removal procedure.
Effectiveness Results
For Post-Approval Study (P160048): Effectiveness data will be presented once the primary endpoint of the study is reached at 12 months following the completion of all insertions.
For Eversense CGM Non-Adjunctive PAS (P160048/S006): Effectiveness data will be based on data from all enrolled subjects who have data evaluable for both phases and will be presented after all subjects complete 12 months.
|
| Actual Number of Patients Enrolled |
For P160048: 273
For P160048/S006: 376
|
| Actual Number of Sites Enrolled |
For P160048 (Adjunctive Use): 6
For P160048/S006 (Non-Adjunctive Use): 21
|
| Patient Follow-up Rate |
For P160048: 97.4% (266/273)
For P160048/S006: 78.5% (289/376)
|
