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The study was pulled by the sponsor due to lack of funding.
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| Name | Class |
|---|---|
| University of Toledo | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photographic Image Capture System | Device | Collection of images of the iris along with corresponding fingerstick blood glucose |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Diabetes Type 1 and 2
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Toledo, Health Science Campus | Toledo | Ohio | 43614 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | New Device for OPTICAL Determination of Blood Glucose Level | Single arm, using device to determine blood glucose level for all |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | New Device for OPTICAL Determination of Blood Glucose Level | Single arm, using device to determine blood glucose level for all |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | 60 day period |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | New Device for OPTICAL Determination of Blood Glucose Level | Single arm, using device to determine blood glucose level for all |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Basil Akpunonu, MD | University of Toledo | 419-383-4909 | Basil.Akpunonu@utoledo.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Participants |
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| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| New Device for OPTICAL Determination of Blood Glucose Level |
Single arm, using device to determine blood glucose level for all |
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| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
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