A Study to Investigate a Transdermal Continuous Glucose Monitoring System in Diabetic Patients for a Period of 28 Days

Overview

Single-centre, open label (unblinded). A maximum of 48 patients will be enrolled in 4 Cohorts of 10 patients and 2 potential replacements each. Diabetic patients (type 1 and 2). Duration up to 11 weeks: up to 6 weeks of screening phase (42 days); 4 weeks of treatment/measurement phase (28 days, depending on sensor functionality) and 1 week of follow up (7 days)

This study is an investigational study, which will be conducted only at one site in Germany. The investigators, the patient and the sponsor will be unblinded. The eligibility of the patient is determined in up to two steps, a screening (see inclusion criteria) and in case of women of childbearing potential a urine pregnancy test at the day of sensor insertion (independent of any re-screening). Women of childbearing potential are only enrolled after a negative outcome of the urine pregnancy test. The screening results are valid up to 42 days. Within that time the first measurement visit including the insertion of the device should be performed. If the first measurement visit is delayed a re-screening has to be performed. Should the patient not pass the re-screening, the patient is considered as a screening failure and must be excluded. The trial is structured into three phases, the screening/enrolment phase, the insertion/measurement phase and the follow-up phase. Screening/Enrolment Phase: Up to 6 weeks (42 days), 1 visit Insertion/Measurement phase: Up to 4 weeks (28 days), up to 6 in-house measurement visits Follow-up Phase: 1 week (7 days), 1 visit

Conditions

Interventions

Eligibility

Locations (1)

Outcomes