Salivary Glycated Albumin

NCT03235492 | Withdrawn

• 1 other identifier: HP-00076395
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes Mellitus

Keywords

diabetes; salivary glycated albumin; HbA1c

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

SmartAlbu

EXPERIMENTAL

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

Interventions

SmartAlbu DEVICE

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

SmartAlbu

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• individuals with type 1 or type 2 diabetes
• non diabetic controls
• Age: 18 to 80
• Body mass index \>18.5kg / m2

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Stephen N Davis, MBBS

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Medicine

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: August 1, 2017
• Study Start: August 24, 2017
• Primary Completion: December 5, 2023
• Study Completion: December 5, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)