Diabetes Mellitus
Conditions
Keywords
diabetes, salivary glycated albumin, HbA1c
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).
Interventions
DEVICESmartAlbu
Plan: 1. Consent an individual 2. Measure and record temperature, blood pressure, heart rate, height and weight 3. Obtain two samples of saliva for the SmartAlbu portable salivary sensor 4. Take a venous blood sample for HbA1c and 5. Glycated albumin 6. Obtain blood sample from a finger stick for point of care HbA1c device
Sponsors
University of Maryland, Baltimore
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Salivary glycated albumin vs. blood glycated albumin | 30 min | Whether the ratio of glycated albumin and total albumin in saliva is equivalent to blood. |
| 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. |
Countries
United States
Outcome results
None listed