Blood Glucose Monitoring Based on Imaging of the Eye
| Registry | NCT02236364 |
|---|
| Status | Terminated - The study was pulled by the sponsor due to lack of funding. |
|---|
| Study type | Observational |
|---|
| Enrollment | 25 (Actual) |
|---|
| Sponsor | University of Toledo Health Science Campus (Other); collaborators: University of Toledo |
|---|
| Conditions | Diabetes |
|---|
| Interventions | Photographic Image Capture System (Device) |
|---|
| Dates | start 2014-08-01, primary completion 2015-05-01, completion 2015-05-01, first posted 2014-09-10, last updated 2025-08-13 |
|---|
| Locations | 1 site in United States |
|---|
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Diabetes All trials of Photographic Image Capture System
-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
Expand all sections · Collapse all
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Participants with type 1 or type 2 diabetes | | Device: Photographic Image Capture System | 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 (Device): Collection of images of the iris along with corresponding fingerstick blood glucose
+Outcome measures
Primary outcomes
- Data Acquisition for Continued Algorithm Development Using Photographic Images of the Iris Compared to Fingerstick Glucose Concentration [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.
+Eligibility
Sex: All, ages: 18 Years to 75 Years
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
+Posted results
Participant flow
| Milestone | New Device for OPTICAL Determination of Blood Glucose Level |
|---|
| Started | 25 |
| Completed | 0 |
| Not completed | 25 |
Outcome results
- Data Acquisition for Continued Algorithm Development Using Photographic Images of the Iris Compared to Fingerstick Glucose Concentration (Primary)
Adverse events
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| New Device for OPTICAL Determination of Blood Glucose Level | 0/25 (0.0%) | 0/25 (0.0%) | 0/25 (0.0%) |
+Locations (1)
| Facility | City | Country | Status |
|---|
| University of Toledo, Health Science Campus | Toledo, Ohio | United States | |