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

NCT06867965 | Completed DMC

• 1 other identifier: P-4.1-C-0.1
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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)

Conditions

Diabetes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Lag time

  6 measurements within 14 days

• Stability of measurements

  6 measurements within 14 days

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

  6 measurements within 14 days

• Signal to noise ratio

  6 measurements within 14 days

• Signal drift

  6 measurements within 14 days

Study Arms (1)

BellySense system

EXPERIMENTAL

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

Device: BellySense

Interventions

BellySense DEVICE

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

BellySense system

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• EyeSense GmbH: lead

Study Sites (1)

Diabetes Instiut Heidelberg

Heidelberg, 69115, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Christoph Hasslacher, Prof. Dr.

  Diabetesinstitut Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: March 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)