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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P160048 / PAS001 |
| Date Original Protocol Accepted |
09/18/2018
|
| Date Current Protocol Accepted |
03/22/2023
|
| Study Name |
Post-Approval Study
|
| Device Name |
EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The purpose of this post-approval study (PAS) is to provide long-term safety and effectiveness of the Eversense CGM System (PMA Application P160048) in the post-market setting.
This is a prospective, multi-center study, whereby up to 400 subjects will be enrolled in the United States at up to 30 sites. The subjects will have one Sensor inserted by trained health care professionals approximately every 3 months. Sensors will be inserted in the upper arm of the subjects.
This is a new enrollment study.
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| Study Population |
Subjects may be included in the PAS if they fit the following inclusion criteria:
1. Subject has diabetes mellitus
2. Subject is greater than 18 years of age
Subjects may not be included in the PAS if they fulfill the following exclusion criteria:
1. Subject will require a planned MRI during the period of Sensor insertion
2. Subject is critically ill or hospitalized
3. Subject has a known contraindication to dexamethasone or dexamethasone acetate
4. Subjects requiring intravenous mannitol or mannitol irrigation solutions
5. Female subjects who are pregnant, planning on becoming pregnant or nursing
6. Subjects on hybrid closed loop systems or closed loop systems
7. Subjects on other CGM systems
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| Sample Size |
A total of 1400 Sensor cycles contributing to the analysis is planned.
Based on data from the PRECISE (n=81 subjects), PRECISE II (n=90 subjects), PRECISION (n=35 subjects) and PMCF (n=1686 subjects)
studies, a total of 31 events occurred that would meet the definition of the primary safety endpoint in this study. With a total of 1892 subjects, this
equates to an observed rate of approximately 1.6% with an associated 95% confidence interval of 1.1% to 2.3%. As there is variability associated with this sample, as evidenced by the confidence interval, a conservative expected rate of events for this study is 2.3%. The planned sample size of
1400 total cycles) with this expected rate should provide greater than 95% power for the test of the performance goal of 4%.
Meeting the performance goal of 4% for the planned sample size would require a worst-case observation of a rate of approximately 3% or less (i.e.,
41 or fewer events among 1400 cycles). This result will be clinically acceptable and similar to results observed in past studies.
A total of 273 enrolled subjects will achieve a total of at least 1400 Sensor cycles.
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| Key Study Endpoints |
The primary safety endpoint is the incidence of the composite of infection, secondary procedures to remove the sensor, or procedure-related adverse events of at least moderate severity.
Other safety endpoints include:
Rate of all device-related and insertion and removal procedure-related adverse events (serious and non-serious events) through 27 months post-first sensor insertion
Rate of device breakage through 27 months post-first sensor insertion
Rate of device-related and insertion and removal procedure-related serious adverse events through 27 months post-first sensor insertion
Subgroup analysis of safety endpoints based on:
o Age (<65 years vs. >65 years, minimum 40 subjects)
Diabetes type (I vs. II)
Race (non-Caucasian vs. Caucasian)
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| Follow-up Visits and Length of Follow-up |
Every 90 or 180 days (depending on whether a subject is using the 90-day or 180-day sensor) for sensor insertion/removal. Also 15 and 45 days postsensor insertion to enable documentation of any adverse events. Total duration of follow up is expected to be 24 months.
|
| 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
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| Actual Number of Patients Enrolled |
For P160048: 273
For P160048/S006: 376
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| Actual Number of Sites Enrolled |
For P160048 (Adjunctive Use): 6
For P160048/S006 (Non-Adjunctive Use): 21
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| Patient Follow-up Rate |
For P160048: 97.4% (266/273)
For P160048/S006: 78.5% (289/376)
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