Salivary Glycated Albumin

Study Overview
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Brief Summary
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(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).

Official Title
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Clinical Study of Salivary Glycated Albumin

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: SmartAlbu


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SmartAlbu<br>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. | Device: SmartAlbu<br>* Plan: Consent an individual Measure and record temperature, blood pressure, heart rate, height and weight Obtain two samples of saliva for the SmartAlbu portable salivary sensor Take a venous blood sample for HbA1c and Glycated albumin Obtain blood sample from a finger stick for point of care HbA1c device<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, salivary glycated albumin, HbA1c