Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
The purpose of this clinical investigation is to evaluate the accuracy of the Eversense® continuous Glucose Monitoring System (Eversense® 180 CGM System) measurements when compared with reference standard measurements up to 180 days of sensor use. The investigation will also evaluate safety of the Eversense® 180 CGM System usage.
Interventions
DEVICEContinuous Glucose Monitoring System
The Eversense® 180 CGM System
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. Adult subjects, age ≥18 years 2. Clinically confirmed diagnosis of diabetes mellitus for ≥1 year 3. Subject has signed an informed consent form and is willing to comply with protocol requirements
Exclusion criteria
1. History of unexplained severe hypoglycemia in the previous 6 months. Severe hypoglycemia is defined as hypoglycemia resulting in loss of consciousness or seizure 2. History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months 3. Subjects with gastroparesis 4. Female subjects of childbearing capacity (defined as not surgically sterile or not menopausal for ≥ 1 year) who are lactating or pregnant, intending to become pregnant, or not practicing birth control during the course of the study. 5. A condition preventing or complicating the placement,operation, or removal of the Sensor or wearing of transmitter, including upper extremity deformities or skin condition. 6. Symptomatic coronary artery disease; unstable angina; myocardial infarction, transient ischemic attack or stroke in the past 6 months; uncontrolled hypertension (systolic\>160 mm Hg or diastolic \>100 mm Hg at time of screening); current congestive heart failure; history of cardiac arrhythmia (benign PACs and PVCs allowed). Subjects with asymptomatic coronary artery disease (e.g. CABG, stent placement or angioplasty) may participate if negative stress test within 1 year prior to screening and written clearance from Cardiologist documented. 7. Hematocrit \<30% or \>60% 8. History of hepatitis B, hepatitis C, or HIV 9. Current treatment for a seizure disorder unless written clearance by neurologist to participate in study 10. History of adrenal insufficiency 11. Currently receiving (or likely to need during the study period): immunosuppressant therapy; chemotherapy; anticoagulant/antithrombotic therapy (excluding aspirin); glucocorticoids (excluding ophthalmic or nasal). This exclusion does include the use of inhaled glucocorticoids and the use of topical glucocorticoids (over sensor site only); antibiotic for chronic infection (e.g. osteomyelitis, endocarditis) 12. A condition requiring or likely to require magnetic resonance imaging (MRI) 13. Known topical or local anesthetic allergy 14. Known allergy to glucocorticoids 15. Any condition that in the investigator's opinion would make the subject unable to complete the study or would make it not in the subject's best interest to participate in the study. Conditions include but are not limited to psychiatric conditions, known current or recent alcohol abuse or drug abuse by subject history, a condition that may increase the risk of induced hypoglycemia or risk related to repeated blood testing. Investigator will supply rationale for exclusion 16. Participation in another clinical investigation (drug or device) within 2 weeks prior to screening or intent to participate during the study period 17. The presence of any other active implanted device (as defined further in protocol)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness Measure - Mean Absolute Relative Difference (MARD) for Paired CGM and Reference Glucose Measurements | 180 days | The effectiveness endpoint is the mean absolute relative difference (MARD), calculated for paired CGM Sensor and reference glucose measurements through 180 days post-sensor insertion for reference glucose values from 40-400 mg/dL. MARD is defined as the average of absolute difference of paired Sensor and reference glucose readings divided by the reference glucose reading (reference) for reference glucose values from 40-400 mg/dL, that is: MARD = ((SUM \| (Glucose)sensor - (Glucose)reference \| / (Glucose)reference ) / n ) x 100%, where n is the total number of Sensor and reference glucose pairs after 180 days of sensor use (MARD is expressed as a percent). Lower MARDs indicate higher (better) accuracy. |
| Safety Endpoint - Incidence of Device-related or Sensor Insertion/Removal Procedure-related Serious Adverse Events | 180 days | Incidence of device-related or sensor insertion/removal procedure-related serious adverse events occurring up to 180 days after the insertion procedure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| The Eversense® 180 CGM System All Subject All subjects inserted with a study sensor(s). | 181 |
| Total | 181 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | The Eversense® 180 CGM System All Subject |
|---|---|
| Age, Continuous | 48.6 years STANDARD_DEVIATION 14.9 |
| Body Mass Index Class Normal (<25 kg/m2) | 28 Participants |
| Body Mass Index Class Obese (>30) | 100 Participants |
| Body Mass Index Class Overweight (>25 and <30) | 53 Participants |
| Diabetes type Type 1 | 126 Participants |
| Diabetes type Type 2 | 55 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 158 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| History of ketoacidosis and hypoglycemia in past 6 months Hypoglycemia | 0 Participants |
| History of ketoacidosis and hypoglycemia in past 6 months Ketoacidosis | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 163 Participants |
| Region of Enrollment United States | 181 Participants |
| Sex: Female, Male Female | 96 Participants |
| Sex: Female, Male Male | 85 Participants |
| Type of insulin therapy Continuous insulin infusion pump | 92 Participants |
| Type of insulin therapy Multiple daily injections | 65 Participants |
| Type of insulin therapy None (oral diabetes medications only) | 16 Participants |
| Type of insulin therapy Other (Basal only or 1 injection per day) | 8 Participants |
| Years since diabetes diagnosis | 22.0 years STANDARD_DEVIATION 13.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 181 | 0 / 43 |
| other Total, other adverse events | 118 / 181 | 30 / 43 |
| serious Total, serious adverse events | 7 / 181 | 3 / 43 |
Outcome results
Primary
Effectiveness Measure - Mean Absolute Relative Difference (MARD) for Paired CGM and Reference Glucose Measurements
The effectiveness endpoint is the mean absolute relative difference (MARD), calculated for paired CGM Sensor and reference glucose measurements through 180 days post-sensor insertion for reference glucose values from 40-400 mg/dL. MARD is defined as the average of absolute difference of paired Sensor and reference glucose readings divided by the reference glucose reading (reference) for reference glucose values from 40-400 mg/dL, that is: MARD = ((SUM \| (Glucose)sensor - (Glucose)reference \| / (Glucose)reference ) / n ) x 100%, where n is the total number of Sensor and reference glucose pairs after 180 days of sensor use (MARD is expressed as a percent). Lower MARDs indicate higher (better) accuracy.
Time frame: 180 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| The Eversense® 180 CGM System All Subject | Effectiveness Measure - Mean Absolute Relative Difference (MARD) for Paired CGM and Reference Glucose Measurements | 9.1 percent |
| The Eversense® 180 CGM System SBA Subgroup | Effectiveness Measure - Mean Absolute Relative Difference (MARD) for Paired CGM and Reference Glucose Measurements | 8.5 percent |
Primary
Safety Endpoint - Incidence of Device-related or Sensor Insertion/Removal Procedure-related Serious Adverse Events
Incidence of device-related or sensor insertion/removal procedure-related serious adverse events occurring up to 180 days after the insertion procedure.
Time frame: 180 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| The Eversense® 180 CGM System All Subject | Safety Endpoint - Incidence of Device-related or Sensor Insertion/Removal Procedure-related Serious Adverse Events | 0 serious adverse events |
| The Eversense® 180 CGM System SBA Subgroup | Safety Endpoint - Incidence of Device-related or Sensor Insertion/Removal Procedure-related Serious Adverse Events | 0 serious adverse events |