A Study to Investigate a Transdermal Continuous Glucose Monitoring System in Diabetic Patients for a Period of 28 Days

NCT06868043 | Terminated DMC

• 1 other identifier: P-4.2-C-0.1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Single-centre, open label (unblinded). A maximum of 48 patients will be enrolled in 4 Cohorts of 10 patients and 2 potential replacements each. Diabetic patients (type 1 and 2). Duration up to 11 weeks: up to 6 weeks of screening phase (42 days); 4 weeks of treatment/measurement phase (28 days, depending on sensor functionality) and 1 week of follow up (7 days)

Conditions

Diabetes (DM)

Keywords

diabetes management; continuous glucose monitoring

Outcome Measures

Primary Outcomes (2)

• Short and mid term performance of the transdermal CGM sensor determined as MARD

  Mean absolute relative difference (MARD) of FiberSense system to blood glucose

  0, 3, 7, 14, 21 and 28 days

• Incidence of adverse events

  Assessment of adverse events and local tolerability occurred during the study

  0, 3, 7,14, 21, 28 and 35-38 days

Secondary Outcomes (6)

• Stability of the blood glucose to fluorescence correlation

  0, 3, 7, 14, 21 and 28 days

• Changes in blood glucose to fluorescence lag time over a period of up to 28 days

  0, 3, 7, 14, 21 and 28 days

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

  0, 3, 7, 14, 21 and 28 days

• Signal-to-noise ratio

  0, 3, 7, 14, 21 and 28 days

• Signal drift

  0, 3, 7, 14, 21 and 28 days

Study Arms (4)

Cohort A

EXPERIMENTAL

Subjects will wear 2 FiberSense systems (arm and abdomen) inserted on day 00 and a comparator continuous glucose monitoring (CGM) system on abdomen, changed on weekly basis. They will participate in six clinic in-house sessions on days 00, 03, 07, 14, 21 and 28. There will be no home use days, solely several hours of extended use blood glucose readings after selected in-clinic sessions.

Device: FiberSense System

Cohort B

EXPERIMENTAL

Subjects will wear 2 FiberSense systems (arm and abdomen) inserted on day 00 and a comparator CGM system on abdomen, changed on weekly basis. They will participate in six clinic in-house sessions on days 00, 03, 07, 14, 21 and 28. Home use measurement days will be scheduled to wear FiberSense systems for 8-12 hours on days directly before and after a measurement visit day - day 6, 8, 13, 15, 20, 22, and 27.

Device: FiberSense System

Cohort C

EXPERIMENTAL

Subjects will wear 2 FiberSense systems (arm and abdomen) inserted on day 00 and a comparator CGM system on abdomen, changed on weekly basis. They will participate in six clinic in-house sessions on days 00, 03, 07, 14, 21 and 28. Home use measurement days will be scheduled to handle and wear FiberSense systems independently on daily basis (min. 8 hours) between measurement visit days - day 4-6, 8-13, 15-20, and 22-27. In addition, interim visits are scheduled at Day 10, 17, and 24 for sensor site and adverse event assessment.

Device: FiberSense System

Cohort D

EXPERIMENTAL

Subjects will wear 2 FiberSense systems (arm and abdomen) inserted on day 00 and a comparator CGM system on abdomen, changed on weekly basis. They will participate in six clinic in-house sessions on days 00, 03, 07, 14, 21 and 28. Home use measurement days will be scheduled to handle and wear FiberSense systems independently on daily basis (min. 8 hours) between measurement visit days - day 4-6, 8-13, 15-20, and 22-27. In addition, interim visits are scheduled at Day 10, 17, and 24 for sensor site and adverse event assessment.

Device: FiberSense System

Interventions

FiberSense System DEVICE

FiberSense system, a novel CGM system using interstitial fluid (ISF) glucose as an indicator of blood glucose levels by diabetic patients

Cohort A; Cohort B; Cohort C; Cohort D

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
• Negative urine pregnancy test immediately before sensor insertion (only women of childbearing potential)
• Signed written Informed Consent

You may not qualify if:

• Inability to follow the protocol schedule
• Participating in another clinical trial
• Pregnant or lactating females, , including positive urine pregnancy test immediately before sensor insertion
• Any known hypersensitivity to any of the products used in the study, including preservatives etc. Especially hypersensitivity against legumes
• Tattoos at the abdominal or upper arm skin area where the fiber sensor is supposed to be placed
• 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 addiction
• 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: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: July 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: June 1, 2014
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)