Feasibility Study of a Novel Subcutaneous Continuous Gluc... | NCT06867965

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

NCT06867965

Sponsor

EyeSense GmbH

Status

Completed

Last Update Posted

Mar 10, 2025Actual

Enrollment

8Actual

Phase

Not Applicable

Conditions

Diabetes

Interventions

BellySense

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010Actual

Primary Completion Date

Nov 2011Actual

Completion Date

Nov 2011Actual

First Submitted Date

Mar 4, 2025

First Submission Date that Met QC Criteria

Mar 5, 2025

First Posted Date

Mar 10, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2025

Last Update Posted Date

Mar 10, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
BellySense	Device	BellySense is a novel CGM system, based on a fiber-optical sensor placed through the dermis of the patient.	BellySense system

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Lag time	Determine changes in blood glucose to fluorescence lag time (in minutes)	6 measurements within 14 days
Stability of measurements	Stability of the FiberSense fluorescence measurement signals over the wearing time

Other Outcomes

Not provided

Eligibility Module

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%

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christoph Hasslacher, Prof. Dr.	Diabetesinstitut Heidelberg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Diabetes Instiut Heidelberg		Heidelberg		69115	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided