Salivary Glycated Albumin

University of Maryland Baltimore (UMB)

Status: Withdrawn

Conditions: Diabetes Mellitus

Treatments: Device: SmartAlbu

Study type: Interventional

Funder types: Other

Identifiers

NCT03235492

HP-00076395

Details and patient eligibility

About

(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).

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 123 individuals with type 1 or type 2 diabetes
• 53 non diabetic controls
• Age: 18 to 80
• Body mass index >18.5kg / m2

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

SmartAlbu

Experimental group

Description:

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.

Treatment:

Device: SmartAlbu