Validation of the Diabetes Deep Neural Network Score for Diabetes Mellitus Screening
Diabetes
About this trial
This is an interventional diagnostic trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Study Population
Alternative Sample Group
The investigators will conduct an electronic medical record (EMR) query of individuals in the University of California, San Francisco (UCSF) primary care clinics without a prior diagnosis of DM and who are undergoing, or who have recently undergone, a lab measured HBA1c before or after 1 month of enrollment. sample size estimation for testing the estimated AUROC in the validation sample vs. the null value of AUC 0.7. The investigators will target an enrollment of 5006 subjects in order to obtain a pre-specified AUROC 95% confidence interval width of 0.07 (i.e. AUROC = 0.76 [95%CI 0.725, 0.795]). The investigators assume that ~4% of the cohort will have undiagnosed diabetes based on national prevalence estimates.
The investigators also aim to perform a sensitivity analysis to estimate the DNN performance in a target general population without a diabetes diagnosis. The investigators will recruit patients from the UCSF EHR system without a history of diabetes, no prior HBA1c measured, and no history of known diabetic risk factors. The investigators will target an enrollment of 1000 subjects in order to obtain a pre-specified AUROC 95% confidence interval width of 0.18 (i.e. AUROC = 0.76 [95%CI 0.67, 0.85]). The investigators assume that ~3% of the cohort will have undiagnosed diabetes based on national prevalence estimates.