Salivary Glycated Albumin

Not Applicable

Withdrawn

Brief Summary: (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).

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Acute illness (within 7 days) - respiratory infection, fever above 38 °C, sinusitis infection, severe allergies.
Individuals with known sickle cell, pregnancy, hemoglobinopathies, renal failure
Subjects unable to give voluntary informed consent

Arm && Interventions

Group	Intervention	Description
SmartAlbu	SmartAlbu	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.

Primary Outcome Measures

Name	Time	Method
Salivary glycated albumin vs. glycosylated hemoglobin (HbA1c)	30 min	To investigate whether the non-invasive SmartAlbu portable salivary sensor is as accurate as standard tests that measure HbA1c.
Salivary glycated albumin vs. blood glycated albumin	30 min	Whether the ratio of glycated albumin and total albumin in saliva is equivalent to blood.

Secondary Outcome Measures

Name	Time	Method

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