Feasibility Trial of a Sub-conjunctival Insert

EyeSense GmbH8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Diabetes (DM)

Interventions

OMI and PhotometerDEVICE

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

Eligibility

Sex: ALLMin age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Correlation between OMI signal and blood glucose

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