Clinical trial NCT06867965: Feasibility Study of a Novel Subcutaneous Continuous Glucose Monitoring System in Diabetics
Official title: A Study to Investigate the Function, Safety and Tolerability of a Subcutaneous Continuous Glucose Monitoring System in Diabetic Patients (Type 1 and 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: EyeSense GmbH
Sponsor class: INDUSTRY
First posted: 2025-03-10
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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)

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

Eligibility criteria: 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%

Primary outcomes:
measure: Correlation between blood glucose and interstitial fluid (ISF) glucose concentration
timeFrame: 6 measurements within 14 days
measure: Adverse event reporting
timeFrame: 14 days
Secondary outcomes:
measure: Lag time
timeFrame: 6 measurements within 14 days
measure: Stability of measurements
timeFrame: 6 measurements within 14 days
measure: Correlation between the fluorescence readings of the sensor and capillary blood glucose measurements
timeFrame: 6 measurements within 14 days
measure: Signal to noise ratio
timeFrame: 6 measurements within 14 days
measure: Signal drift
timeFrame: 6 measurements within 14 days
measure: Patient impression
timeFrame: after 14 days
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Diabetes Instiut Heidelberg
Study officials:
affiliation: Diabetesinstitut Heidelberg
name: Christoph Hasslacher, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: