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

Not Applicable

Terminated

• Conditions: Diabetes (DM)

• Registration Number: NCT06868043
• Lead Sponsor: EyeSense GmbH

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)

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.

The eligibility of the patient is determined in up to two steps, a screening (see inclusion criteria) and in case of women of childbearing potential a urine pregnancy test at the day of sensor insertion (independent of any re-screening). Women of childbearing potential are only enrolled after a negative outcome of the urine pregnancy test. 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: Up to 6 weeks (42 days), 1 visit

Insertion/Measurement phase: Up to 4 weeks (28 days), up to 6 in-house measurement visits

Follow-up Phase: 1 week (7 days), 1 visit

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2012-10
• Study Completion: 2014-06
• Status Verified: 2025-03
• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-05
• Last Update Submitted: 2025-03-05
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Exclusion Criteria

• 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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Short and mid term performance of the transdermal CGM sensor determined as MARD	0, 3, 7, 14, 21 and 28 days	Mean absolute relative difference (MARD) of FiberSense system to blood glucose
Incidence of adverse events	0, 3, 7,14, 21, 28 and 35-38 days	Assessment of adverse events and local tolerability occurred during the study

Secondary Outcome Measures

Name	Time	Method
Stability of the blood glucose to fluorescence correlation	0, 3, 7, 14, 21 and 28 days	FiberSense fluorescence measurement signals calculated in glucose values and compared to glucose values measured with: a: SMBG device (Bayer Contour next USB), b: CGM device (Dexcom Seven plus), c: Laborat orysystem (Hitado Super GL compact)
Changes in blood glucose to fluorescence lag time over a period of up to 28 days	0, 3, 7, 14, 21 and 28 days	Lag time (in minutes) between FiberSense readings and corresponding laboratory blood glucose values during glucose excursions
Correlation between the fluorescence readings of the sensor and capillary blood glucose measurements	0, 3, 7, 14, 21 and 28 days	Calculation of MARD of FiberSense against a commercial self-monitoring blood glucose meter
Signal-to-noise ratio	0, 3, 7, 14, 21 and 28 days
Signal drift	0, 3, 7, 14, 21 and 28 days	Drift of the FiberSense fluorescent measurement signals over the wearing time
User satisfaction assessed by the Likert scale	35-38 days	Subjective impression of the patients assessed by 5-point Likert scale (1- strongly agree to 5 - strongly disagree)

Trial Locations

Locations (1)

Diabetes Instiut Heidelberg; 🇩🇪 Heidelberg, Germany