Noninvasive Blood Glucose Monitoring Method Based on Imaging of the Eye

NCT02236364 | Terminated Results

• 1 other identifier: Irisense
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Photographic Image Capture System DEVICE

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

Participants with type 1 or type 2 diabetes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Diabetes Type 1 and 2

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toledo Health Science Campus: lead
• University of Toledo: collaborator

Study Sites (1)

University of Toledo, Health Science Campus

Toledo, Ohio, 43614, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Basil Akpunonu, MD
• Organization: University of Toledo

Basil.Akpunonu@utoledo.edu

419-383-4909

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2014
• First Posted: September 10, 2014
• Study Start: August 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: August 13, 2025
• Results First Posted: August 13, 2025

Record last verified: 2025-05

Locations

US (1)