Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
The purpose of this multi-center, prospective clinical study is to evaluate the performance of a novel, implanted Senseonics continuous glucose monitoring system (Senseonics CGM System) compared to Yellow Springs Instrument (YSI) glucose analyzer reference standard measurements using a next generation transmitter and algorithm. Other measures evaluated will be the effects of compression on performance and the safety of the Senseonics CGM system.
Interventions
DEVICEContinuous glucose monitoring system
Implanted continuous glucose monitoring 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 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. 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. 4. A condition preventing or complicating the placement, operation, or removal of the Sensor or wearing of transmitter, including upper extremity deformities or skin condition. 5. 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 Premature Atrial Contractions (PACs) and Premature Ventricular Contractions (PVCs) allowed). Subjects with asymptomatic coronary artery disease (e,g, coronary artery bypass graft (CABG), stent placement or angioplasty) may participate if negative stress test within 1 year prior to screening and written clearance from Cardiologist documented. 6. Hematocrit \<30% or \>55% 7. History of hepatitis B, hepatitis C, or HIV 8. Current treatment for a seizure disorder unless written clearance by neurologist to participate in study 9. History of adrenal insufficiency 10. 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) 11. A condition requiring or likely to require magnetic resonance imaging (MRI) 12. Known topical or local anesthetic allergy 13. Known allergy to glucocorticoids 14. 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 15. Participation in another clinical investigation (drug or device) within 2 weeks prior to screening or intent to participate during the study period 16. The presence of any other active implanted device (as defined further in protocol) 17. The presence of any other CGM sensor or transmitter located in upper arm (other location is acceptable)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of CGM System Through 90 Days Post-Insertion (MARD for Paired CGM and Reference Glucose Measurements) | 90 days | The effectiveness endpoint is the mean absolute relative difference (MARD), calculated for all paired Senseonics CGM System and reference glucose measurements through 90 days of Sensor use. MARD is defined as the average of absolute difference of paired Senseonics CGM System and reference glucose readings divided by the reference glucose reading (reference) for all reference glucose values, that is: MARD = ((SUM \| (Glucose)sensor - (Glucose)reference \| / (Glucose)reference ) / n ) x 100%, where n is the total number of CGM and reference glucose pairs after 90 days of sensor use (MARD is a percentage). Lower MARDs indicate higher (better) accuracy. |
| Safety Endpoint | 90 days | Incidence of device-related or sensor insertion/removal procedure-related serious adverse events through 90 days post-insertion. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Continuous Glucose Monitoring Device Senseonics continuous glucose monitoring system
Continuous glucose monitoring system: Implanted continuous glucose monitoring system | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Continuous Glucose Monitoring Device |
|---|---|
| Age, Continuous | 51.6 years STANDARD_DEVIATION 15.7 |
| Body Mass Index Class: Normal, Overweight, Obese | 28.2 kg/m2 STANDARD_DEVIATION 5.4 |
| Diabetes Type: Type I, Type II Type I | 25 Participants |
| Diabetes Type: Type I, Type II Type II | 10 Participants |
| Dominant Hand: Right, Left Left | 2 participants |
| Dominant Hand: Right, Left Right | 33 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/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 32 Participants |
| Race/Ethnicity, Customized Hispanic | 4 Participants |
| Race/Ethnicity, Customized More than One Race | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Non-Hispanic | 31 Participants |
| Region of Enrollment United States | 35 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 18 Participants |
| Type of insulin therapy Continuous insulin infusion pump | 19 Participants |
| Type of insulin therapy Multiple daily injections | 11 Participants |
| Type of insulin therapy None | 5 Participants |
| Years Since Diabetes Diagnosis | 26.0 years STANDARD_DEVIATION 14.3 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 15 / 35 |
| serious Total, serious adverse events | 3 / 35 |
Outcome results
Primary
Accuracy of CGM System Through 90 Days Post-Insertion (MARD for Paired CGM and Reference Glucose Measurements)
The effectiveness endpoint is the mean absolute relative difference (MARD), calculated for all paired Senseonics CGM System and reference glucose measurements through 90 days of Sensor use. MARD is defined as the average of absolute difference of paired Senseonics CGM System and reference glucose readings divided by the reference glucose reading (reference) for all reference glucose values, that is: MARD = ((SUM \| (Glucose)sensor - (Glucose)reference \| / (Glucose)reference ) / n ) x 100%, where n is the total number of CGM and reference glucose pairs after 90 days of sensor use (MARD is a percentage). Lower MARDs indicate higher (better) accuracy.
Time frame: 90 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Continuous Glucose Monitoring Device | Accuracy of CGM System Through 90 Days Post-Insertion (MARD for Paired CGM and Reference Glucose Measurements) | 9.6 percent |
Primary
Safety Endpoint
Incidence of device-related or sensor insertion/removal procedure-related serious adverse events through 90 days post-insertion.
Time frame: 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Continuous Glucose Monitoring Device | Safety Endpoint | 0 serious adverse events |