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

EyeSense

Status

Completed

Conditions

Diabetes

Treatments

Device: BellySense

Study type

Interventional

Funder types

Industry

Identifiers

NCT06867965

P-4.1-C-0.1

Details and patient eligibility

About

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)

Full description

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

Enrollment

8 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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%