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NCT05303051 | WITHDRAWN | Diabetes


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

University of California, San Francisco

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 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.

Condition or disease

Diabetes

Intervention/treatment

Application Validation

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 0 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : Validation of the Diabetes Deep Neural Network Score for Diabetes Mellitus Screening
Actual Study Start Date : 2023-06-01
Estimated Primary Completion Date : 2023-06-01
Estimated Study Completion Date : 2025-04-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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

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

Location Details

NCT05303051


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Locations


Not yet recruiting

United States, California

University of California, San Francisco

San Francisco, California, United States, 94143

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