Noninvasive Blood Glucose Monitoring Method Based on Imaging of the Eye

University of Toledo Health Science Campus

Status: Terminated

Conditions: Diabetes

Treatments: Device: Photographic Image Capture System

Study type: Observational

Funder types: Other

Identifiers

NCT02236364

Irisense

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

25 participants in 1 patient group

Participants with type 1 or type 2 diabetes

Description:

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

Treatment:

Device: Photographic Image Capture System