Diabetes
Conditions
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
Interventions
DEVICEPhotographic Image Capture System
Collection of images of the iris along with corresponding fingerstick blood glucose
Sponsors
University of Toledo
University of Toledo Health Science Campus
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| New Device for OPTICAL Determination of Blood Glucose Level Single arm, using device to determine blood glucose level for all | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | New Device for OPTICAL Determination of Blood Glucose Level |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 58.36 years |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
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.
Time frame: 60 day period
Population: The study was terminated by the sponsor prior to any analysis. Purpose of this study was to collect iris images for Sponsor's use in algorithm development. Images were stored in the prototype device that the Sponsor took back. Attempt was made to locate and contact the Sponsor, IRISense, but the company was dissolved in 2021. Since the company does not exist anymore neither does the data that the company was in possession of. Data is not available now nor will it be available in the future.