Diabetes insulin-dependent diabetes mellitus
Conditions
Interventions
None listed
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 at least 1 year of duration) on multiple daily injections (>2 injections per day) or 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: Subjects will be denied participation in the investigation if they meet any of the following key, exclusion criteria: 1. History of severe hypoglycemia in the 6 months immediately prior to study start. 2. Severe diabetic Ketoacidosis in the past 6 months. 3. Females who are lactating, pregnant or intending to become pregnant during the course of the investigation, defined as 3.1 Not postmenopausal for at least 1 year OR 3.2 Not surgically sterile, OR 3.3 If of child bearing potential, the subject is not practicing birth control, not willing to avoid pregnancy for the period of study participation, has a positive urine pregnancy test at screening or has a positive urine pregnancy test at the time of the Sensor insertion procedure. 4. Any condition preventing or complicating the placement, operation or removal of the Sensor, including but not limited to: 4.1 Upper extremity deformities that would impede the placement of the Sensor or application of the external Transmitter. 4.2 Any skin condition that may affect Sensor insertion or external Transmitter placement. 5. 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 but not limited to: 5.1 Anemia, defined as either: 5.1.1 Hemoglobin (Hgb) value for females of 50% or <30% at screening. 11. Topical or local anesthetic allergy. 12. Known current or recent alcohol or drug abuse by subject history. 13. Participation in another clinical investigation within 30 days preceding screening, or intention to participate in any other clinical investigation during the period of this study. 14. The presence of any other active implanted device, whether turned on or off. Passive implants are allowed. 15. A condition requiring or li
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objectives of this investigation are to assess accuracy and longevity of the Senseonics CGM System modifications during up to 90 days of Sensor use in the clinic and during home use and to monitor safety of the Senseonics CGM System over the first 90 days of Sensor use by measuring the incidence of device-related and procedure-related serious adverse events during the investigation. System modifications include evaluating the biocompatible coating configurations of polyethylene glycol diacrylate (PEG) with or without PET and with or without Nylon 66. These coatings are on the outer surface of the Sensor and are designed to improve the accuracy and/or longevity of the System. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of this investigation are as follows: * To determine other relevant Senseonics CGM System performance measures. * To evaluate the incidence of procedure and device-related adverse events in clinic and home use. * To evaluate the incidence of all adverse events in clinic and home use. | — |
Countries
Netherlands
Outcome results
None listed