Noninvasive Blood Glucose Monitoring Method Based on Imaging of the Eye

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-05-31

Brief Summary

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Previous animal studies done by Dr. Brent Cameron in 2013 at the Univ. of Toledo have shown that glucose present in the fluid in the front of the eye, called the aqueous humor, correlates well with blood glucose. As blood glucose changes, the optical properties of the aqueous humor change, causing a change in the appearance of the iris of the eye.. The data collected in this study will be shared with IRISense to assist in validating the algorithm being used to develop the database needed. The data collected so far is in a narrow band of the normal glycemic range (healthy volunteers). We will collect standard digital photographic images of the eyes of subjects with diabetes along with corresponding blood glucose concentrations using the finger stick glucose monitoring method. In order to do this we will use standard digital photography techniques that is embedded in our benchtop prototype device

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Detailed Description

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Conditions

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Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with type 1 or type 2 diabetes

Participants with type 1 or type 2 diabetes will have images of their iris collected at the same time as a fingerstick blood sugar

Photographic Image Capture System

Intervention Type DEVICE

Collection of images of the iris along with corresponding fingerstick blood glucose

Interventions

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Photographic Image Capture System

Collection of images of the iris along with corresponding fingerstick blood glucose

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Diabetes Type 1 and 2 and can be verified by the principal investigator

Exclusion Criteria

* Patients with any disease or abnormality of the eye
* Patients who are mentally incapacitated, cognitively impaired or with severe psychological disorders and cannot sign consent on their own

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No