CLINICAL TRIAL

Application Validation for Diabetes Mellitus

Waitlist Available · 18+ · All Sexes · San Francisco, CA

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

See full description

About the trial for Diabetes Mellitus

Eligible Conditions
Diabetes Mellitus · Diabetes

Treatment Groups

This trial involves 2 different treatments. Application Validation is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
Application Validation
DEVICE
Experimental Group 2
Application Validation
DEVICE

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
You have a family history of DM. show original
You have one or more lifestyle risk factors. show original
You are willing to undergo a lab measured HBA1c. show original
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 without risk factors for DM
Age > 40 years old
Obesity (BMI > 30)
Ownership of a smart phone
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: PPG measurements and DNN score to be obtained within one month oh HBA1c measurement
Screening: ~3 weeks
Treatment: Varies
Reporting: PPG measurements and DNN score to be obtained within one month oh HBA1c measurement
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: PPG measurements and DNN score to be obtained within one month oh HBA1c measurement.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Application Validation will improve 3 primary outcomes and 3 secondary outcomes in patients with Diabetes Mellitus. Measurement will happen over the course of Retraining to occur after complete collection of PPG measurements and HBA1c data. The investigators estimate this will occur one year after enrollment..

Retrain the DNN algorithm
RETRAINING TO OCCUR AFTER COMPLETE COLLECTION OF PPG MEASUREMENTS AND HBA1C DATA. THE INVESTIGATORS ESTIMATE THIS WILL OCCUR ONE YEAR AFTER ENROLLMENT.
By collecting PPG waveform data in patients with laboratory-confirmed diabetes, the investigators will be able to train the algorithm using the more specific diagnosis of laboratory-confirmed diabetes. The investigators will assess the performance of the DNN Score once retrained using HbA1c. The DNN will be trained using similar approaches as the investigators have previously published
RETRAINING TO OCCUR AFTER COMPLETE COLLECTION OF PPG MEASUREMENTS AND HBA1C DATA. THE INVESTIGATORS ESTIMATE THIS WILL OCCUR ONE YEAR AFTER ENROLLMENT.
Assess the performance of the DNN score in different ethnicity and skin tones
PPG MEASUREMENTS AND DNN SCORE TO BE OBTAINED WITHIN ONE MONTH OH HBA1C MEASUREMENT
The investigators will aim to recruit individuals of different races/ethnicities and skin tones to assess the performance of the DNN score in different races/ethnicities.
PPG MEASUREMENTS AND DNN SCORE TO BE OBTAINED WITHIN ONE MONTH OH HBA1C MEASUREMENT
The area under the receiver operating characteristic (AUROC) of the DNN Score as compared with one HBA1c measurement based on > 2 PPG measurements.
PPG MEASUREMENTS AND DNN SCORE TO BE OBTAINED WITHIN ONE MONTH OH HBA1C MEASUREMENT
Participants will provide seven total PPG measurements by their own smartphone camera. After PPG measurements are obtained, the DNN algorithm will be deployed and be reported a as a DNN score. The investigators will assess the DNN performance the area under the receiver operating characteristic (AUROC) of the DNN Score of > 2 PPG measurements as compared with the HBA1c.
PPG MEASUREMENTS AND DNN SCORE TO BE OBTAINED WITHIN ONE MONTH OH HBA1C MEASUREMENT
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.
PPG MEASUREMENTS AND DNN SCORE TO BE OBTAINED WITHIN ONE MONTH OH HBA1C MEASUREMENT
Participants will provide seven total PPG measurements by their own smartphone camera. After PPG measurements are obtained, the DNN algorithm will be deployed and be reported a as a DNN score. The investigators will assess the DNN performance by the the area under the receiver operating characteristic (AUROC) of the DNN Score as compared with the HBA1c based on the DNN score from an average of 2 PPG measurements.
PPG MEASUREMENTS AND DNN SCORE TO BE OBTAINED WITHIN ONE MONTH OH HBA1C MEASUREMENT
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.
PPG MEASUREMENTS AND DNN SCORE TO BE OBTAINED WITHIN ONE MONTH OH HBA1C MEASUREMENT
Participants will provide seven total PPG measurements by their own smartphone camera. After PPG measurements are obtained, the DNN algorithm will be deployed and be reported as a DNN score. The investigators will assess the DNN performance by the Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value of the DNN Score as compared with the HBA1c based on the DNN score from an average of 2 PPG measurements.
PPG MEASUREMENTS AND DNN SCORE TO BE OBTAINED WITHIN ONE MONTH OH HBA1C MEASUREMENT
The Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value of the DNN Score as compared with one HBA1c measurement based on >2 PPG measurements.
PPG MEASUREMENTS AND DNN SCORE TO BE OBTAINED WITHIN ONE MONTH OH HBA1C MEASUREMENT
Participants will provide seven total PPG measurements by their own smartphone camera. After PPG measurements are obtained, the DNN algorithm will be deployed and be reported a as a DNN score. The investigators will assess the DNN performance by the Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value of the DNN Score of > 2 PPG measurements as compared with the HBA1c.
PPG MEASUREMENTS AND DNN SCORE TO BE OBTAINED WITHIN ONE MONTH OH HBA1C MEASUREMENT

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get diabetes mellitus a year in the United States?

About 70 million adults are affected by diabetes. Diabetes is the seventh leading cause of death in adults in the United States. Diabetes causes a significant burden annually on public health professionals, public health, and health care systems.

Anonymous Patient Answer

What are common treatments for diabetes mellitus?

Patients with diabetes have a variety of pharmacotherapy options for their respective treatment regimens. A key part of achieving good metabolic control is to be aware of their disease and to maximize the quality of care they receive. Diabetes is a chronic disease requiring regular monitoring of blood glucose levels and frequent monitoring of weight. Patient education about medications is important, as is careful medication monitoring and review for hypoglycemia. Diabetes can be successfully controlled via diet, exercise, pharmacotherapy, and preventive care.\n

Anonymous Patient Answer

What causes diabetes mellitus?

Glucose-insensitive diabetes mellitus is hereditary, with a strong correlation between the first and second degree of relatedness. Diabetes mellitus is probably [a complex disorder that is the result of the interaction of genetic and environmental factors] (http://www.med.umich.edu/~biol/biocatalogs/pediatric-diabetes.html).

Anonymous Patient Answer

What is diabetes mellitus?

Diabetes mellitus has an impact on every aspect of someone's life, not just their health and their health care utilisation. It is a risk factor for a number of diseases and diseases that can lead to many different complications including cardiovascular diseases and many others. About half of the diabetic population in Canada use insulin daily (1 in 3 use it routinely) and about a third of the total diabetic population use blood glucose-testing daily. There is a large discrepancy between the use of glucose-test kits and the actual number of blood glucose tests performed.

Anonymous Patient Answer

What are the signs of diabetes mellitus?

In diabetics, there should be early awareness of symptoms that could be related to this disease. For some of these, the diagnosis of diabetes is made, but more accurate diagnosis can be established if clinical signs are noticed. The symptoms observed were similar to the symptoms of other diseases with which diabetes were thought to be associated. However, because the symptoms were not specific to diabetes, their diagnostic value was limited. For other diseases, signs related to diabetes have been described.

Anonymous Patient Answer

Can diabetes mellitus be cured?

Diabetes does not appear to be cureable. While many can improve their glucose control, some cannot. Most diabetic patients continue to suffer from complications such as diabetic retinopathy and nephropathy, which require careful long-term control to prevent disability or death. Preventative measures, such as smoking cessation and treatment of pre-diabetes with lifestyle changes and medication, can reduce the likelihood of developing complications of diabetes.

Anonymous Patient Answer

Is application validation typically used in combination with any other treatments?

While validation should be used in the clinical settings of diabetes, its purpose is not only to determine whether a medication is effective but also to provide evidence of why particular medications provide a better treatment experience for patients as we know it is. This is important in order to better inform patients and clinicians about the effectiveness of particular medications as we seek to reduce the health care costs incurred by [diverting patients from ineffective treatments to effective ones] and for clinicians to better define the indications for [medication management].

Anonymous Patient Answer

What is the latest research for diabetes mellitus?

The literature reveals the existence of new anti-diabetic drugs with potential to reduce the negative effect of diabetes on organ systems. For example, the discovery of newer oral drugs that induce β-cell regeneration may offer novel solutions for the prevention of complications of diabetes. However, evidence from well-designed and well-conducted clinical trials is still lacking.

Anonymous Patient Answer

What does application validation usually treat?

This is the first study that shows an application in this particular cohort, comparing the different ways to integrate care and support in patients with diabetes mellitus. Data from a recent study of the current study can be put in the context of a large and comprehensive literature review with the aim of informing the debate about what are the most important aspects of validating applications in health care and care services.

Anonymous Patient Answer

Who should consider clinical trials for diabetes mellitus?

It is important for patients to be aware of the advantages and disadvantages of clinical trials and understand that even though trials are often promising, some do not give them a clear answer about whether their medication will help or hurt their health.

Anonymous Patient Answer

What is the average age someone gets diabetes mellitus?

Diabetes mellitus is an independent risk factor for death, especially cancer, heart disease, and stroke. Diabetes and its complications are already the #1 and #2 causes of death in people who develop diabetes and the diabetes complications occur earlier in life. People are living longer and have healthier people than before. However, people with diabetes have one of the highest mortality rates of all age groups. More than 40% of people with diabetes die of cardiovascular disease, the leading cause of death in Americans with diabetes. Diabetes treatment can delay, but not block, deaths and can increase quality of life (not just mortality).

Anonymous Patient Answer

How serious can diabetes mellitus be?

Findings from a recent study suggest that this group of people have a high risk for developing serious cardiovascular disease with the diabetes mellitus, the main reason being that many develop microalbuminuria during the course of the disease and this may reflect a small subclinical heart attack. The most important predictor of new cardiovascular events was a lack of treatment to control blood glucose levels. It appears necessary to have people with diabetes receiving treatment and having blood glucose levels taken to check, and to take other medical measures to try to prevent new cardiovascular events in this group of people.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Diabetes Mellitus by sharing your contact details with the study coordinator.