Purpose

(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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Device: SmartAlbu
    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

Recruiting Locations

University of Maryland
Baltimore, Maryland 21201
Contact:
Maka S Hedrington, MD
410-706-5623
mhedrington@som.umaryland.edu

More Details

NCT ID
NCT03235492
Status
Recruiting
Sponsor
University of Maryland

Study Contact

Maka S Hedrington, MD
410-706-5623
mhedrington@som.umaryland.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.