Noninvasive Blood Glucose Monitoring Method Based on Imaging of the Eye

Blood Glucose Monitoring Based on Imaging of the Eye

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

Study Overview

• Status: Terminated
• Conditions: Diabetes
• Intervention / Treatment: Device: Photographic Image Capture System

• Study Type: Observational
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Toledo, Ohio, United States, 43614
      • University of Toledo, Health Science Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with Diabetes Type 1 and 2

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Device: Photographic Image Capture System; Collection of images of the iris along with corresponding fingerstick blood glucose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Data Acquisition for Continued Algorithm Development Using Photographic Images of the Iris Compared to Fingerstick Glucose Concentration	Eight digital photographic image of the subject's iris will be obtained at various times during each visit under standard illumination using the developed instrumentation. A point-of-care fingerstick blood glucose reading will be taken with an FDA approved blood glucose measurement device (i.e., Contour, Bayer Healthcare, LLC) as close to simultaneously as possible with the photograph.	60 day period

Collaborators and Investigators

• Sponsor: University of Toledo Health Science Campus
• Collaborators: University of Toledo

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: September 8, 2014
• First Submitted That Met QC Criteria: September 9, 2014
• First Posted (Estimated): September 10, 2014

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 8, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Irisense