Feasibility Trial of a Sub-conjunctival Insert

NCT07105332 | Terminated DMC

• 1 other identifier: P-1.1-C-01
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this single-centre, open label prospective study is to investigate a novel ocular mini insert (OMI) for detection of blood glucose levels in human subjects. First, the optimal technical parameters for measurement are determined on healthy subjects. Secondly, performance measurements follow investigating relationship between OMI signal and blood glucose in diabetes patients during short sessions with oral glucose tolerace test.

Conditions

Diabetes (DM)

Keywords

sub-conjunctival implant; flash glucose monitoring; EyeSense, eye implant, glucose measurement in the eye

Outcome Measures

Primary Outcomes (2)

• Correlation between OMI signal and blood glucose

  Correlation between OMI fluorescence readings of subconjunctival interstitial fluid glucose concentration and capillary blood glucose level

  1-2 times weekly for 10 weeks after insertion

• Adverse Events Reporting

  wound healing and conjunctival hyperaemia

  at each visit, up to 10 months

Secondary Outcomes (5)

• Sensitivity and signal to noise ratio of the photometer

  1-2 times weekly for 10 weeks after insertion

• Long term stability of insert

  1-2 times weekly for 10 weeks after insertion

• Targeting of measurement beam

  1-2 times weekly for 10 weeks after insertion

• Subjective impressions

  10 months

• Lag time

  1-2 times weekly for 10 weeks after insertion

Study Arms (2)

Cohort - Healthy subjects

EXPERIMENTAL

2 healthy subjects will test OMI and Photometer for a period of up to 5 months: with sub-conjunctivaly implanted OMI participating on in-clinic sessions to optimize and adjust the measurement system (photometer).

Device: OMI and Photometer

Cohort - Diabetic patients

EXPERIMENTAL

8 diabetic patients will test OMI and Photometer: wearing sub-conjunctivaly implanted OMI for a period of up to 10 months and participating on up to 20 in-clinic sessions with blood glucose challenge to measure the performance of the system.

Device: OMI and Photometer

Interventions

OMI and Photometer DEVICE

A glucose sensitive ocular mini insert (OMI) is placed sub-conjunctivaly. When exited by photometer the glucose concentration is measured.

Cohort - Diabetic patients; Cohort - Healthy subjects

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Be of legal age or alternatively above 16 with written persmission of legal guardian.
• Signed written Informed Consent.

You may not qualify if:

• Pregnant or lactating females.
• Poorly controlled diabetes mellitus with prior hemoglobin A1C greater than 10% or fasting glucose over 150 mg/dl.
• Any known allergies, especially iodine.
• Glaucoma patient.
• Any acute disease.
• Any present condition that would prevent from fasting or glucose challenge.
• Any present condition that would prevent from insertion.

Sponsors & Collaborators

• EyeSense GmbH: lead

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Holger Mietz, Prof. Dr.

  63739 Aschaffenburg, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: August 5, 2025
• Study Start: December 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: July 1, 2008
• Last Updated: August 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share