Diabetes Mellitus
Conditions
Brief summary
The purpose of this clinical investigation is to evaluate the effectiveness of modified Sensor designs on the longevity (up to 180 days) of the Senseonics Continuous Glucose Monitoring (CGM) System. The investigation will also evaluate safety of the Senseonics CGM System usage, while in the clinic and during home use.
Interventions
DEVICEContinuous Glucose Monitoring System
Effectiveness and safety of a 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
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Male and Female Subjects meeting all of the following inclusion criteria will be included in this study: 1. Subjects age ≥12 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
Subjects meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CGM Relative Difference to Laboratory Reference reported as MARD | 180 days | Mean absolute relative difference (MARD) for paired Sensor and reference measurements through 180 days post-insertion for reference glucose values from 40-400 mg/dL will be calculated for comparison. |
Countries
Canada
Outcome results
None listed