Diabetes Mellitus
Conditions
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 (YSI glucose analyzer). The investigation will also evaluate safety of the Senseonics CGM System usage, while in the clinic and during home use.
Interventions
DEVICEContinuous Glucose Monitoring Device (Senseonics)
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
Subjects meeting all of the following inclusion criteria will be included in this study: 1. Males and females ≥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 has signed an informed consent document and is willing to comply with protocol requirements
Exclusion criteria
Subjects meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy (mean absolute relative difference) compared to be reference device should be less than 20% | 90 days | To determine accuracy of the Senseonics CGM System measurements over successive periods of 30 days of Sensor use through 180 days post-insertion. |
Countries
Netherlands
Outcome results
None listed