SmartAlbu for Diabetes Monitoring

Recruiting in Palo Alto (17 mi)

Overseen byStephen N Davis, MBBS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Maryland, Baltimore

No Placebo Group

Trial Summary

What is the purpose of this trial?(1) to determine whether the ratio of glycated albumin and total albumin in saliva is equivalent to blood and (2) to investigate whether the non-invasive SmartAlbu portable salivary sensor is as accurate as standard tests that measure glycosylated hemoglobin (HbA1c).

Eligibility Criteria

This trial is for people aged 18-80 with a BMI over 18.5 who have type 1 or type 2 diabetes, including a control group without diabetes. It's not suitable for those unable to consent, recently ill, pregnant, or with conditions like sickle cell disease and renal failure.

Inclusion Criteria

You weigh enough for your height (BMI is not too low).

Age: 18 to 80

The study is looking for 123 people who have either type 1 or type 2 diabetes.

+1 more

Exclusion Criteria

Acute illness (within 7 days) - respiratory infection, fever above 38 °C, sinusitis infection, severe allergies.

Subjects unable to give voluntary informed consent

You have sickle cell disease, are pregnant, have hemoglobin disorders, or have kidney failure.

Participant Groups

The study tests if the SmartAlbu device can accurately measure the ratio of glycated albumin in saliva compared to blood levels and see how it stacks up against standard HbA1c tests for monitoring diabetes.

1Treatment groups

Experimental Treatment

Group I: SmartAlbuExperimental Treatment1 Intervention

If a participant agrees, after obtaining informed consent, the investigator will measure and record temperature, blood pressure, heart rate, height and weight. The participant will be given detailed instruction on how to hold the container and will be asked to spit (or deposit) their saliva up to the indicated line. The procedure will be performed twice to study the reproducibility of the test. The participant will then be asked to have a standard blood draw of 2-3 mls of blood into a vacutainer tube for analysis of HbA1c at the central lab and 1-2 mls of blood for glycated albumin for assay analysis, and a finger stick for point of care HbA1c measurement.