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

NCT ID: NCT06867965

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-11-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

BellySense system

8 diabetic patients will wear a BellySense system at the upper arm or abdomen for up to 14 days.

Group Type: EXPERIMENTAL

BellySense

Intervention Type: DEVICE

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

Interventions

BellySense

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

Intervention Type: DEVICE

Eligibility Criteria

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%

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EyeSense GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christoph Hasslacher, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Diabetesinstitut Heidelberg

Locations

Diabetes Instiut Heidelberg

Heidelberg, , Germany

Countries

Germany

Other Identifiers

P-4.1-C-0.1

Identifier Type: -

Identifier Source: org_study_id