Diabetes MellitusNCT03235492
Salivary Glycated Albumin
A study testing SmartAlbu in people with Diabetes Mellitus, run by University of Maryland, Baltimore at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- SmartAlbu
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2017to 5 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 123 individuals with type 1 or type 2 diabetes
- 53 non diabetic controls
- Age: 18 to 80
- Body mass index >18.5kg / m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Diabetes Mellitus
- Being tested
- SmartAlbu
- Keywords
- diabetes, salivary glycated albumin, HbA1c
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartAlbuDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: SmartAlbu |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary glycated albumin vs. blood glycated albumin
Whether the ratio of glycated albumin and total albumin in saliva is equivalent to blood.
Measured: 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.
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start24 Aug 2017
- Primary completion5 Dec 2023
- Study completion5 Dec 2023
Why it stopped: The study team did not receive the necessary study equipment from our international partners.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen N. Davis, MBBS, University of Maryland, Baltimore
- Investigators
- Stephen N Davis, MBBS, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235492
- Sponsor's protocol ID
- HP-00076395
- Status last verified
- Dec 2023
- First submitted
- 25 Jul 2017
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Salivary Glycated Albumin
- ClinicalTrials.gov ID
- NCT03235492
- Acronym / sponsor ID
- HP-00076395
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes, salivary glycated albumin, HbA1c
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study team did not receive the necessary study equipment from our international partners.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 24 Aug 2017 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 1 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
(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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SmartAlbu | Experimental | Device: SmartAlbuIf 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 123 individuals with type 1 or type 2 diabetes
- 53 non diabetic controls
- Age: 18 to 80
- Body mass index >18.5kg / m2
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmartAlbuPlan: 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 | Device | SmartAlbu |
Primary outcome
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen N Davis, MBBS principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmartAlbu in people with Diabetes Mellitus, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary glycated albumin vs. blood glycated albumin (time frame: 30 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.