Diabetes Mellitus
Conditions
Keywords
type 1 diabetes, type 2 diabetes, CGM, implantable, accuracy, longevity
Brief summary
The purpose of this clinical investigation is to evaluate the accuracy of the Senseonics Continuous Glucose Monitoring System (Senseonics CGM System) measurements when compared with reference standard measurements The investigation will also evaluate safety of the Senseonics CGM System usage.
Interventions
DEVICEContinuous Glucose Monitoring System
Accuracy and safety assessment of a 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. 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 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. 6. Hematocrit \<30% or \>55% 7. History of hepatitis B, hepatitis C, or HIV 8. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CGM Relative Difference to Laboratory Reference Reported as MARD | 90 days | Mean absolute relative difference (MARD) for paired Sensor and reference measurements through 90 days post-insertion for reference glucose values from 40-400 mg/dL will be calculated for comparison. |
Other
| Measure | Time frame | Description |
|---|---|---|
| CGM System Agreement With Reference Control | 90 days | The percentage of system readings within ±15 mg/dL or 15% of YSI reference values (15/15%) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Accuracy Assessment, CGMS To determine accuracy of the Senseonics Continuous Glucose Monitoring System measurements through approximately 90 days post-insertion. Manipulation of glucose levels during multiple clinic days
Continuous Glucose Monitoring System: Accuracy and safety assessment of a continuous glucose monitoring device | 90 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Accuracy Assessment, CGMS |
|---|---|
| Age, Continuous | 45.1 years STANDARD_DEVIATION 16.2 |
| Body mass Index Normal (<25 kg/m2) | 22 Participants |
| Body mass Index Obese (≥ 30) | 41 Participants |
| Body mass Index Overweight (≥25 and <30) | 27 Participants |
| Diabetes Type Type I | 61 Participants |
| Diabetes Type Type II | 29 Participants |
| Dominant Hand Left | 12 Participants |
| Dominant Hand Right | 78 Participants |
| History of Hypoglycemia | 1 Participants |
| History of Ketoacidosis | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 77 Participants |
| Region of Enrollment United States | 90 Participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 54 Participants |
| Type of insulin therapy continuous insulin infusion pump | 43 Participants |
| Type of insulin therapy Multiple daily injections | 24 Participants |
| Type of insulin therapy None | 20 Participants |
| Type of insulin therapy Other | 3 Participants |
| Years since diabetes diagnosis | 20.1 years STANDARD_DEVIATION 13.7 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 90 |
| other Total, other adverse events | 43 / 90 |
| serious Total, serious adverse events | 1 / 90 |
Outcome results
Primary
CGM Relative Difference to Laboratory Reference Reported as MARD
Mean absolute relative difference (MARD) for paired Sensor and reference measurements through 90 days post-insertion for reference glucose values from 40-400 mg/dL will be calculated for comparison.
Time frame: 90 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Accuracy Assessment, CGMS | CGM Relative Difference to Laboratory Reference Reported as MARD | 8.5 percent |
Other Pre-specified
CGM System Agreement With Reference Control
The percentage of system readings within ±15 mg/dL or 15% of YSI reference values (15/15%)
Time frame: 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Accuracy Assessment, CGMS | CGM System Agreement With Reference Control | 86.8 percent of readings within 15/15% |