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NCT03235492 Clinical Trial

Salivary Glycated Albumin

Diabetes Mellitus Clinical Trial

Official title:
Clinical Study of Salivary Glycated Albumin

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03235492
Other study ID # HP-00076395
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date August 24, 2017
Est. completion date December 5, 2023

Study information
Verified date December 2023
Source University of Maryland, Baltimore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 5, 2023
Est. primary completion date December 5, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States University of Maryland Baltimore Maryland

Sponsors (1)
Lead Sponsor Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Salivary glycated albumin vs. blood glycated albumin Whether the ratio of glycated albumin and total albumin in saliva is equivalent to blood. 30 min
Primary 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
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