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Digital Biomarker Validation for Diabetes
N/A
Waitlist Available
Led By Geoff Tison, MD, MPH
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age > 18 years old
Participants without a prior diagnosis of DM
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ppg measurements and dnn score to be obtained within one month oh hba1c measurement
Awards & highlights
Study Summary
This trial is studying a digital biomarker, called the DNN score, to see if it can be used to screen for type 2 diabetes mellitus. The DNN score uses photoplethysmography (PPG) technology on the commercial smartphone camera. The trial's aim is to see if the DNN score is as accurate as a glycated hemoglobin (HbA1c) test in detecting diabetes.
Who is the study for?
This trial is for adults over 18, especially those over 40 or with obesity, a family history of diabetes, lifestyle risks (like lack of exercise), who own a smartphone and can consent to the study. It's not for people with previous high HbA1c levels (>6.5%), diagnosed diabetes, or issues that prevent PPG signal collection like digit amputation.Check my eligibility
What is being tested?
The study tests the Diabetes Deep Neural Network Score using smartphone camera technology to screen for Type 2 Diabetes Mellitus. Participants' PPG waveforms will be compared against standard HbA1c tests to validate this non-invasive screening method.See study design
What are the potential side effects?
Since this is an observational study involving data collection through smartphones without any medical intervention, there are no direct side effects from participating in this trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
Select...
I have never been diagnosed with diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ ppg measurements and dnn score to be obtained within one month oh hba1c measurement
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~ppg measurements and dnn score to be obtained within one month oh hba1c measurement
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assess the performance of the DNN score in different ethnicity and skin tones
The Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value of the DNN Score as compared with one HBA1c measurement based an average of two PPG measurements.
The area under the receiver operating characteristic (AUROC) of the DNN Score as compared with one HBA1c measurement, based an average of two PPG measurements.
Secondary outcome measures
Retrain the DNN algorithm
The Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value of the DNN Score as compared with one HBA1c measurement based on >2 PPG measurements.
The area under the receiver operating characteristic (AUROC) of the DNN Score as compared with one HBA1c measurement based on > 2 PPG measurements.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Study PopulationExperimental Treatment1 Intervention
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.
Group II: Alternative Sample GroupExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Azumio Inc.UNKNOWN
Bristol-Myers SquibbIndustry Sponsor
2,645 Previous Clinical Trials
4,124,993 Total Patients Enrolled
4 Trials studying Diabetes
632 Patients Enrolled for Diabetes
University of California, San FranciscoLead Sponsor
2,510 Previous Clinical Trials
15,237,701 Total Patients Enrolled
15 Trials studying Diabetes
155,514 Patients Enrolled for Diabetes
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot gather PPG signals due to finger amputation or excessive shaking.Your HBA1c level was measured within a month before joining the study, or it will be measured within a month after joining.I am over 40, possibly overweight, may have a family history of diabetes, and I own a smartphone.I am older than 18 years.You do not own a smartphone.You do not have any factors that increase your risk for diabetes.I have never been diagnosed with diabetes.Your HBA1c level has been higher than 6.5% in the past.I have a history of diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Study Population
- Group 2: Alternative Sample Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial have any openings for participants?
"According to the clinicaltrials.gov database, this medical trial is not accepting new participants at present. Initially published on July 1st 2022 and recently amended on July 6th, it appears that no further candidates can be admitted into this research project; however, 1267 other studies are presently seeking out volunteers."
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