diabetes Diabetes type 1
Conditions
Interventions
Each subject will have two Sensors inserted on Visit 2 (Day 0), one Sensor in
each upper arm. One of the Sensors in each subject will be designated as the
*primary Sensor.* A subset of subjects will
Sponsors
Senseonics, Incorporated
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Males and Females Aged *18 years of age. 2. Clinically confirmed diagnosis of diabetes mellitus for a duration of 1 year and uses insulin therapy for their diabetes management (including subjects on insulin pump therapy). 3. Subject understands study procedures and risks, is willing to comply with protocol requirements, and has signed an informed consent document.
Exclusion criteria
Exclusion criteria: 1. History of severe hypoglycemia in the last 6 months prior to study start. 2. Severe diabetic ketoacidosis in the past 6 months. 3. Any condition preventing or complicating the placement, operation or removal of the Sensor including upper extremity deformities or skin condition. 4. Any medical condition or illness that in the judgment of the investigator might interfere with the procedures, results or compliance during the course of this investigation, or increase the risk of induced hypoglycemia or repeated blood testing including significantly impaired hepatic function and renal failure. 5. Known microvascular (diabetic) complications, including active proliferative diabetic retinopathy or macular edema, active nonproliferative retinopathy, diabetic nephropathy including active retinopathy, or neuropathy. 6. Hematocrit >50% or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean absolute relative difference (MARD) of Sensor readings compared with the reference measurements (YSI) at successive 30-days intervals through 180 days post-insertion. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Additional accuracy measures during the period of Sensor use * mean absolute difference; median absolute relative difference; agreement as expressed by readings within 20%, 30% and 40% of reference values; trend accuracy measured over time at different glucose rates of change and starting ranges. 2. Clarke Error Grid, Consensus Error Grid and Continuous Glucose Error Grid. 3. Deming regression analysis 4. Bland Altman analysis 5. Low/High glucose alert/alarm performance * accuracy of detection of hypo- and hyperglycemic states; sensitivity and specificity. (The glucose alert and alarm performance of the Senseonics CGM System will be evaluated through post-processing of data collected) | — |
Countries
Netherlands
Outcome results
None listed