Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
A Post Approval Study to Evaluate the Long-term Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System over repeat insertion and removal cycles and to demonstrate the long-term safety of the Eversense® CGM System
Detailed description
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. In the premarket setting, the PRECISE II and PRECISION studies demonstrated safety and accuracy of the CGM system in estimating blood glucose levels compared to reference blood glucose analyzer levels to 90 days. The PROMISE study demonstrated safety and accuracy of the CGM system up to 180 days. This PAS study will provide safety and effectiveness data up to 27 months of repeated use.
Interventions
DEVICEEversense® CGM System
Continuous Glucose monitoring device
Sponsors
Senseonics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject has diabetes 2. Subject is greater than 18 years of age
Exclusion criteria
1. Subject is critically ill or hospitalized 2. Subject has a known contraindication to dexamethasone or dexamethasone acetate 3. Subjects requiring intravenous mannitol or mannitol irrigation solutions 4. Female subjects who are pregnant, planning on becoming pregnant or nursing 5. Subjects on hybrid closed loop systems or closed loop systems 6. Subjects on other CGM systems
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Long-term Safety of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting. | up to 27 months | The primary safety endpoint was the incidence of the composite of infection, secondary procedures to remove the Sensor, or procedure-related adverse events of at least moderate severity, with a performance goal of \< 4%. |
| The Long-term Effectiveness of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting. | Baseline and Month 12 | The primary effectiveness endpoint was Time in Range, which is defined as glucose values between 70 mg/dL and 180 mg/dL, at 12 months post-first Sensor insertion compared to the first month post-first Sensor insertion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction With CGM System Use (CGM-SAT Scale) | up to 27 months | CGM-Sat is a 44 question, 5-point scale (1 = strongly agree, 5 = strongly disagree); higher scores reflect more satisfaction with CGM. |
| Patient Reported Diabetes Distress Scale (DDS) | Screening, Day 180, Day 360, and Day 720 | The DDS score over the two-year period. DDS17 is a 17 question, 6-point scale (1 = not a problem, 6 = a very serious problem); lower score depicts less distress with diabetes. |
| Success Rate of Insertion Procedures: Overall and by HCP Experience | up to 27 months | Success rate was measured for the first 3 insertions for each inserting HCP, the remaining insertions, as well as overall insertions. |
| Success Rate of Removal Procedures: Overall and by HCP Experience | up to 27 months | Success rate was measured for the first 3 removals for each inserting HCP, the remaining removals, as well as overall removals. |
| The Additional Effectiveness Endpoint of Average Hours of Use Per Day | up to 27 months | — |
| Rate of Removal Procedures With Serious Adverse Events | up to 27 months | — |
| HCP Feedback Questionnaire Regarding Insertion | up to 27 Months | The questions were on a scale of 1-5, with 1 indicating Strongly Agree and 5 indicating Strongly Disagree. |
| HCP Feedback Questionnaire Regarding Removal | up to 27 Months | The questions were on a scale of 1-5, with 1 indicating Strongly Agree and 5 indicating Strongly Disagree. |
| Residual Dexamethasone Level in Explanted Sensors | up to 27 months | The residual dexamethasone (DXA) content in Sensors was analyzed after removal. |
| Rate of Insertion Procedures With Serious Adverse Events | up to 27 months | — |
| The Additional Effectiveness Endpoint of Change in HbA1c Levels at Each 6-month Interval From Baseline | Baseline, Month 6, Month 12, Month 18, and Month 24 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Continuous Glucose Monitoring Device Eversense® CGM system: Continuous Glucose monitoring device that lasts up to 90 days | 273 |
| Total | 273 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | Withdrawal by Subject | 92 |
Baseline characteristics
| Characteristic | Continuous Glucose Monitoring Device |
|---|---|
| Age, Continuous | 44.7 years STANDARD_DEVIATION 14.6 |
| CGM Naive | 71 Participants |
| Diabetes Therapy Regimen Intensive insulin therapy | 263 Participants |
| Diabetes Therapy Regimen Non-insulin medications,basal insulin, lifestyle | 10 Participants |
| Diabetes Type Type 1 | 218 Participants |
| Diabetes Type Type 2 | 55 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 259 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 235 Participants |
| Region of Enrollment United States | 273 participants |
| Sex: Female, Male Female | 123 Participants |
| Sex: Female, Male Male | 150 Participants |
| Years Since Diabetes Diagnosis | 19 years STANDARD_DEVIATION 13 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 273 |
| other Total, other adverse events | 115 / 273 |
| serious Total, serious adverse events | 21 / 273 |
Outcome results
Primary
The Long-term Effectiveness of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting.
The primary effectiveness endpoint was Time in Range, which is defined as glucose values between 70 mg/dL and 180 mg/dL, at 12 months post-first Sensor insertion compared to the first month post-first Sensor insertion.
Time frame: Baseline and Month 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Continuous Glucose Monitoring Device | The Long-term Effectiveness of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting. | Baseline | 62.9 % time in range | Standard Deviation 18.3 |
| Continuous Glucose Monitoring Device | The Long-term Effectiveness of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting. | Month 12 | 62.4 % time in range | Standard Deviation 20.1 |
Primary
The Long-term Safety of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting.
The primary safety endpoint was the incidence of the composite of infection, secondary procedures to remove the Sensor, or procedure-related adverse events of at least moderate severity, with a performance goal of \< 4%.
Time frame: up to 27 months
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Continuous Glucose Monitoring Device | The Long-term Safety of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting. | Infection | 5 Sensor cycle |
| Continuous Glucose Monitoring Device | The Long-term Safety of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting. | Secondary procedure to remove sensor | 24 Sensor cycle |
| Continuous Glucose Monitoring Device | The Long-term Safety of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting. | Procedure-related adverse event of at least moderate severity | 15 Sensor cycle |
Secondary
HCP Feedback Questionnaire Regarding Insertion
The questions were on a scale of 1-5, with 1 indicating Strongly Agree and 5 indicating Strongly Disagree.
Time frame: up to 27 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Continuous Glucose Monitoring Device | HCP Feedback Questionnaire Regarding Insertion | The insertion procedure was easy | 1.1 score on a scale | Standard Deviation 0.4 |
| Continuous Glucose Monitoring Device | HCP Feedback Questionnaire Regarding Insertion | The labeling for use of the blunt dissector and the insertion tool are easy to understand | 1.1 score on a scale | Standard Deviation 0.4 |
| Continuous Glucose Monitoring Device | HCP Feedback Questionnaire Regarding Insertion | The blunt dissector and insertion tool are easy to use | 1.1 score on a scale | Standard Deviation 0.3 |
| Continuous Glucose Monitoring Device | HCP Feedback Questionnaire Regarding Insertion | The training was reflective of what I encountered during the insertion procedure | 1.2 score on a scale | Standard Deviation 0.5 |
Secondary
HCP Feedback Questionnaire Regarding Removal
The questions were on a scale of 1-5, with 1 indicating Strongly Agree and 5 indicating Strongly Disagree.
Time frame: up to 27 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Continuous Glucose Monitoring Device | HCP Feedback Questionnaire Regarding Removal | The removal procedure was easy | 1.5 score on a scale | Standard Deviation 0.8 |
| Continuous Glucose Monitoring Device | HCP Feedback Questionnaire Regarding Removal | The instructions and labeling for the removal were easy to understand | 1.2 score on a scale | Standard Deviation 0.5 |
| Continuous Glucose Monitoring Device | HCP Feedback Questionnaire Regarding Removal | The clamp was easy to use to remove the sensor | 1.5 score on a scale | Standard Deviation 0.7 |
| Continuous Glucose Monitoring Device | HCP Feedback Questionnaire Regarding Removal | The training was reflective of what I encountered during the removal procedure | 1.4 score on a scale | Standard Deviation 0.7 |
Secondary
Patient Reported Diabetes Distress Scale (DDS)
The DDS score over the two-year period. DDS17 is a 17 question, 6-point scale (1 = not a problem, 6 = a very serious problem); lower score depicts less distress with diabetes.
Time frame: Screening, Day 180, Day 360, and Day 720
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Continuous Glucose Monitoring Device | Patient Reported Diabetes Distress Scale (DDS) | Screening | 1.9 score on a scale | Standard Deviation 0.8 |
| Continuous Glucose Monitoring Device | Patient Reported Diabetes Distress Scale (DDS) | Day 180 | 1.7 score on a scale | Standard Deviation 0.7 |
| Continuous Glucose Monitoring Device | Patient Reported Diabetes Distress Scale (DDS) | Day 360 | 1.7 score on a scale | Standard Deviation 0.7 |
| Continuous Glucose Monitoring Device | Patient Reported Diabetes Distress Scale (DDS) | Day 720 | 1.7 score on a scale | Standard Deviation 0.7 |
Secondary
Patient Satisfaction With CGM System Use (CGM-SAT Scale)
CGM-Sat is a 44 question, 5-point scale (1 = strongly agree, 5 = strongly disagree); higher scores reflect more satisfaction with CGM.
Time frame: up to 27 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Continuous Glucose Monitoring Device | Patient Satisfaction With CGM System Use (CGM-SAT Scale) | Day 180 | 4.0 score on a scale | Standard Deviation 0.5 |
| Continuous Glucose Monitoring Device | Patient Satisfaction With CGM System Use (CGM-SAT Scale) | Day 360 | 4.1 score on a scale | Standard Deviation 0.5 |
| Continuous Glucose Monitoring Device | Patient Satisfaction With CGM System Use (CGM-SAT Scale) | Day 720 | 4.1 score on a scale | Standard Deviation 0.5 |
Secondary
Rate of Insertion Procedures With Serious Adverse Events
Time frame: up to 27 months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Continuous Glucose Monitoring Device | Rate of Insertion Procedures With Serious Adverse Events | 1 insertions |
Secondary
Rate of Removal Procedures With Serious Adverse Events
Time frame: up to 27 months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Continuous Glucose Monitoring Device | Rate of Removal Procedures With Serious Adverse Events | 0 removals |
Secondary
Residual Dexamethasone Level in Explanted Sensors
The residual dexamethasone (DXA) content in Sensors was analyzed after removal.
Time frame: up to 27 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Glucose Monitoring Device | Residual Dexamethasone Level in Explanted Sensors | 82.5 percentage of residual DXA | Standard Deviation 5.2 |
Secondary
Success Rate of Insertion Procedures: Overall and by HCP Experience
Success rate was measured for the first 3 insertions for each inserting HCP, the remaining insertions, as well as overall insertions.
Time frame: up to 27 months
Population: The number analyzed in the first 2 rows are the subsets of the overall insertions based on HCP experience.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Continuous Glucose Monitoring Device | Success Rate of Insertion Procedures: Overall and by HCP Experience | First 3 procedures | 100 percentage of successful insertion |
| Continuous Glucose Monitoring Device | Success Rate of Insertion Procedures: Overall and by HCP Experience | >3 procedures done | 99.8 percentage of successful insertion |
| Continuous Glucose Monitoring Device | Success Rate of Insertion Procedures: Overall and by HCP Experience | Overall | 99.8 percentage of successful insertion |
Secondary
Success Rate of Removal Procedures: Overall and by HCP Experience
Success rate was measured for the first 3 removals for each inserting HCP, the remaining removals, as well as overall removals.
Time frame: up to 27 months
Population: The number analyzed in the first 2 rows are the subsets of the overall removals based on HCP experience.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Continuous Glucose Monitoring Device | Success Rate of Removal Procedures: Overall and by HCP Experience | First 3 procedures | 96.1 percentage of successful removals |
| Continuous Glucose Monitoring Device | Success Rate of Removal Procedures: Overall and by HCP Experience | >3 procedures done | 98.7 percentage of successful removals |
| Continuous Glucose Monitoring Device | Success Rate of Removal Procedures: Overall and by HCP Experience | Overall | 98.4 percentage of successful removals |
Secondary
The Additional Effectiveness Endpoint of Average Hours of Use Per Day
Time frame: up to 27 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Glucose Monitoring Device | The Additional Effectiveness Endpoint of Average Hours of Use Per Day | 19 Daily use [hours] | Standard Deviation 7 |
Secondary
The Additional Effectiveness Endpoint of Change in HbA1c Levels at Each 6-month Interval From Baseline
Time frame: Baseline, Month 6, Month 12, Month 18, and Month 24
Population: Change in HbA1c from Baseline at 6-Month Intervals. Window for 6, 12, and 18-month intervals was ± 30 days. Window for 24-month interval was -30 days to anything greater than 24 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Continuous Glucose Monitoring Device | The Additional Effectiveness Endpoint of Change in HbA1c Levels at Each 6-month Interval From Baseline | Baseline | 0 percentage of HbA1c | Standard Deviation 0 |
| Continuous Glucose Monitoring Device | The Additional Effectiveness Endpoint of Change in HbA1c Levels at Each 6-month Interval From Baseline | 6-month | -0.16 percentage of HbA1c | Standard Deviation 1.04 |
| Continuous Glucose Monitoring Device | The Additional Effectiveness Endpoint of Change in HbA1c Levels at Each 6-month Interval From Baseline | 12-month | -0.14 percentage of HbA1c | Standard Deviation 0.96 |
| Continuous Glucose Monitoring Device | The Additional Effectiveness Endpoint of Change in HbA1c Levels at Each 6-month Interval From Baseline | 18-month | -0.10 percentage of HbA1c | Standard Deviation 0.96 |
| Continuous Glucose Monitoring Device | The Additional Effectiveness Endpoint of Change in HbA1c Levels at Each 6-month Interval From Baseline | 24-month | 0.06 percentage of HbA1c | Standard Deviation 1.31 |