Status:
WITHDRAWN
Validation of the Diabetes Deep Neural Network Score for Diabetes Mellitus Screening
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Azumio Inc.
Bristol-Myers Squibb
Conditions:
Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The Validation of the Diabetes Deep Neural Network Score (DNN score) for Screening for Type 2 Diabetes Mellitus (diabetes) is a single center, unblinded, observational study to clinically validating a...
Eligibility Criteria
Inclusion
- Age \> 18 years old
- Participants without a prior diagnosis of DM
- Participants with a recently measured HBA1c one month before enrollment or scheduled to undergo a HBA1c measurement within one month after enrollment
- Participants not scheduled for HBA1c and are willing to undergo a lab measured HBA1c
- Participants without risk factors for DM
- Participants with \> 1 of the following risk factors for DM:
- Age \> 40 years old
- Obesity (BMI \> 30)
- Family history: Any first degree relative with a hx of DM
- Lifestyle risk factors (exercise, smoking, and sleep duration)
- Ownership of a smart phone
- Able to provide informed consent
- Willingness to provide PPG waveforms
Exclusion
- Participants with a history of DM
- Participants with a prior HBA1c \> 6.5%
- Inability to collect PPG signals (digit amputation, excessive tremors, etc)
- Lack of ownership of a smartphone
- Inability or unwillingness to consent and/or follow requirements of the study
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05303051
Start Date
June 1 2023
End Date
April 1 2025
Last Update
April 8 2025
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143