Noninvasive Blood Glucose Monitoring Method Based on Imaging of the Eye

Diabetes Clinical Trial

Official title:

Blood Glucose Monitoring Based on Imaging of the Eye

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02236364
• Other study ID #: Irisense
• Status: Terminated
• Phase: N/A
• First received: September 8, 2014
• Last updated: October 25, 2016
• Start date: August 2014
• Est. completion date: May 2015

Study information

• Verified date: July 2015
• Source: University of Toledo Health Science Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• Contour, Bayer Healthcare, LLC
Blood glucose measurement

Locations

Country	Name	City	State
United States	University of Toledo, Health Science Campus	Toledo	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Toledo Health Science Campus	University of Toledo Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Photographic Images of the eye	The subject will be scheduled for 3 visits. Scheduling for testing will be performed by the principal investigator. Each subject will be required to take part in three individual or group testing sessions of 45-90 minutes over a 60 day period.; 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	No