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

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)

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Device: BellySense

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

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69115
    • Diabetes Instiut Heidelberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BellySense system; 8 diabetic patients will wear a BellySense system at the upper arm or abdomen for up to 14 days.	Device: BellySense; BellySense is a novel CGM system, based on a fiber-optical sensor placed through the dermis of the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between blood glucose and interstitial fluid (ISF) glucose concentration	Mean absolute relative difference (MARD) of fluorescence sensor values and laboratory blood glucose values	6 measurements within 14 days
Adverse event reporting	Incidence of reported ADE, with focus on number of SADE	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lag time	Determine changes in blood glucose to fluorescence lag time (in minutes)	6 measurements within 14 days
Stability of measurements	Stability of the FiberSense fluorescence measurement signals over the wearing time	6 measurements within 14 days
Correlation between the fluorescence readings of the sensor and capillary blood glucose measurements	Mean absolute relative difference (MARD) of fluorescence sensor values and capillary blood glucose values	6 measurements within 14 days
Signal to noise ratio		6 measurements within 14 days
Signal drift		6 measurements within 14 days
Patient impression	Subjective impression of the patients assesed by 5/6-point scale	after 14 days

Collaborators and Investigators

• Sponsor: EyeSense GmbH
• Investigators: Principal Investigator: Christoph Hasslacher, Prof. Dr., Diabetesinstitut Heidelberg

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: March 4, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: P-4.1-C-0.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No