Feasibility Study of a Novel Subcutaneous Continuous Glucose Monitoring System in Diabetics

A Study to Investigate the Function, Safety and Tolerability of a Subcutaneous Continuous Glucose Monitoring System in Diabetic Patients (Type 1 and 2)

Mono-centre, open label (unblinded). 8 patients + 2 potential replacements. Duration up to 9 weeks: up to 6 weeks screening (42 days), 2 weeks of treatment (14 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.

As soon as the eligibility of the patient is confirmed the patient is enrolled. 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: 6 weeks (42 days), 1 visit

Insertion/Measurement phase: Up to 2 weeks (14days), up to 6 measurement visits

Follow-up Phase: 1 week (7 days), 1 visit

Inclusion Criteria:

• Body mass index within the range of 19-40 kg/m2, inclusive
• Diabetes type 1 and 2
• Females (if of childbearing potential) must agree to abstain from sexual intercourse or use reliable forms of contraception e.g. condom or diaphragm with spermicide or oral contraceptives to prevent pregnancy during the study
• Signed written Informed Consent

Exclusion Criteria:

• Inability to follow the protocol schedule
• Participating in another clinical trial, if it is not a "non-investigational clinical study (NICS)
• Pregnant or lactating females,
• Any known hypersensitivity to any of the products used in the study, including preservatives etc.
• Malignancies requiring therapy during the study
• Severe chronic diseases e.g. renal failure, liver cirrhosis etc. which may interfere with the conduct or completion of the study
• Acute severe infection disease at the time of enrolment
• Alcohol and/or drug abuses
• Vulnerable patients (e.g. persons kept in detention)
• Poorly controlled diabetes mellitus with hemoglobin A1C higher than 10%