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Completed

NCT Number: NCT06867965

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

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)

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diabetes Instiut Heidelberg

Heidelberg, 69115, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

BellySense

Device

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

Primary outcomes

  1. Correlation between blood glucose and interstitial fluid (ISF) glucose concentration

    Time frame: 6 measurements within 14 days

    Mean absolute relative difference (MARD) of fluorescence sensor values and laboratory blood glucose values

  2. Adverse event reporting

    Time frame: 14 days

    Incidence of reported ADE, with focus on number of SADE

Secondary outcomes

  1. Lag time

    Time frame: 6 measurements within 14 days

    Determine changes in blood glucose to fluorescence lag time (in minutes)

  2. Stability of measurements

    Time frame: 6 measurements within 14 days

    Stability of the FiberSense fluorescence measurement signals over the wearing time

  3. Correlation between the fluorescence readings of the sensor and capillary blood glucose measurements

    Time frame: 6 measurements within 14 days

    Mean absolute relative difference (MARD) of fluorescence sensor values and capillary blood glucose values

  4. Signal to noise ratio

    Time frame: 6 measurements within 14 days

  5. Signal drift

    Time frame: 6 measurements within 14 days

  6. Patient impression

    Time frame: after 14 days

    Subjective impression of the patients assesed by 5/6-point scale

Sponsors and collaborators

Lead sponsor

EyeSense GmbH

Industry

Registry information

Official study title

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

Acronym: FiberSense

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 10, 2025
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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