Trial Outcomes & Findings for Noninvasive Blood Glucose Monitoring Method Based on Imaging of the Eye (NCT NCT02236364)
NCT ID: NCT02236364
Last Updated: 2025-08-13
Results Overview
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.
TERMINATED
25 participants
60 day period
2025-08-13
Participant Flow
Participant milestones
| Measure |
New Device for OPTICAL Determination of Blood Glucose Level
Single arm, using device to determine blood glucose level for all
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Noninvasive Blood Glucose Monitoring Method Based on Imaging of the Eye
Baseline characteristics by cohort
| Measure |
New Device for OPTICAL Determination of Blood Glucose Level
n=25 Participants
Single arm, using device to determine blood glucose level for all
|
|---|---|
|
Age, Continuous
|
58.36 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 60 day periodPopulation: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
New Device for OPTICAL Determination of Blood Glucose Level
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place