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Salivary Glycated Albumin

NCT ID: NCT03235492

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-24

Study Completion Date

2023-12-05

Brief Summary

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(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).

Detailed Description

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Conditions

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Diabetes Mellitus

Keywords

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diabetes salivary glycated albumin HbA1c

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

SmartAlbu

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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Stephen N. Davis, MBBS

Chairman of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephen N Davis, MBBS

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

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University of Maryland

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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HP-00076395

Identifier Type: -

Identifier Source: org_study_id