Feasibility Trial of a Sub-conjunctival Insert (OMI)

EyeSense

Status: Terminated

Conditions: Diabetes (DM)

Treatments: Device: OMI and Photometer

Study type: Interventional

Funder types: Industry

Identifiers

NCT07105332

P-1.1-C-01

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

8 participants in 2 patient groups

Cohort - Healthy subjects

Experimental group

Description:

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).

Treatment:

Device: OMI and Photometer

Cohort - Diabetic patients

Experimental group

Description:

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.

Treatment:

Device: OMI and Photometer