This study is in progress, not accepting new patients

Validation of the Diabetes Deep Neural Network Score for Diabetes Mellitus Screening

a study on Diabetes

Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California
Dates
study started
completion around

Description

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 previously developed remote digital biomarker, identified as the DNN score, to screen for diabetes. The previously developed DNN score provides a promising avenue to detect diabetes in these high-risk communities by leveraging photoplethysmography (PPG) technology on the commercial smartphone camera that is highly accessible. Our primary aim is to prospectively clinically validate the PPG DNN algorithm against the reference standards of glycated hemoglobin (HbA1c) for the presence of prevalent diabetes. Our vision is that this clinical trial may ultimately support an application to the Food and Drug Administration so that it can be incorporated into guideline-based screening.

Keywords

Diabetes, Diabetes Mellitus, Application Validation, Study Population

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Location

  • UCSF
    San Francisco California 94143 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05303051
Study Type
Interventional
Participants
Expecting 6006 study participants
Last Updated