Feasibility Trial of a Sub-conjunctival Insert

Not Applicable

Terminated

• Conditions: Diabetes (DM)

• Registration Number: NCT07105332
• Lead Sponsor: EyeSense GmbH

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-01
• Primary Completion: 2008-06
• Study Completion: 2008-07-01
• Study First Submitted: 2022-09-05
• Status Verified: 2025-03
• Study First Submitted QC: 2025-07-29
• Last Update Submitted: 2025-07-29
• Study First Posted: 2025-08-05
• Last Update Posted: 2025-08-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Correlation between OMI signal and blood glucose	1-2 times weekly for 10 weeks after insertion	Correlation between OMI fluorescence readings of subconjunctival interstitial fluid glucose concentration and capillary blood glucose level
Adverse Events Reporting	at each visit, up to 10 months	wound healing and conjunctival hyperaemia

Secondary Outcome Measures

Name	Time	Method
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	signal drift and stability of measurement
Targeting of measurement beam	1-2 times weekly for 10 weeks after insertion
Subjective impressions	10 months	subjecs has to answer a questionnaire
Lag time	1-2 times weekly for 10 weeks after insertion	evaluation between device readings and blood glucose concentration