MedPath

Salivary Glycated Albumin

Not Applicable
Withdrawn
Conditions
Diabetes Mellitus
Registration Number
NCT03235492
Lead Sponsor
University of Maryland, Baltimore
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
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

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Salivary glycated albumin vs. glycosylated hemoglobin (HbA1c)30 min

To investigate whether the non-invasive SmartAlbu portable salivary sensor is as accurate as standard tests that measure HbA1c.

Salivary glycated albumin vs. blood glycated albumin30 min

Whether the ratio of glycated albumin and total albumin in saliva is equivalent to blood.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Maryland

🇺🇸

Baltimore, Maryland, United States

University of Maryland
🇺🇸Baltimore, Maryland, United States

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