NCT06867965

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: EyeSense GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed 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

Conditions

• Diabetes

Interventions

Type	Name	Description
DEVICE	BellySense	BellySense is a novel CGM system, based on a fiber-optical sensor placed through the dermis of the patient.

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2025-03-10
• Last updated: 2025-03-10

Locations

1 site across 1 country: Germany