Salivary Glycated Albumin

December 14, 2023 updated by: Stephen N. Davis, MBBS, University of Maryland, Baltimore

Clinical Study of Salivary Glycated Albumin

(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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:

  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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Investigators

  • Principal Investigator: Stephen N Davis, MBBS, University of Maryland, Baltimore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2017

Primary Completion (Actual)

December 5, 2023

Study Completion (Actual)

December 5, 2023

Study Registration Dates

First Submitted

July 25, 2017

First Submitted That Met QC Criteria

July 28, 2017

First Posted (Actual)

August 1, 2017

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HP-00076395

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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