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SmartAlbu for Diabetes Monitoring
N/A
Waitlist Available
Led By Stephen N Davis, MBBS
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 min
Awards & highlights
Study Summary
This trial is testing a new way to measure blood sugar levels that is less invasive than current methods.
Who is the study for?
This trial is for people aged 18-80 with a BMI over 18.5 who have type 1 or type 2 diabetes, including a control group without diabetes. It's not suitable for those unable to consent, recently ill, pregnant, or with conditions like sickle cell disease and renal failure.Check my eligibility
What is being tested?
The study tests if the SmartAlbu device can accurately measure the ratio of glycated albumin in saliva compared to blood levels and see how it stacks up against standard HbA1c tests for monitoring diabetes.See study design
What are the potential side effects?
Since this trial involves non-invasive testing using a salivary sensor, there are minimal expected side effects. However, discomfort from saliva collection may occur.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 min
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 min
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Salivary glycated albumin vs. blood glycated albumin
Salivary glycated albumin vs. glycosylated hemoglobin (HbA1c)
Trial Design
1Treatment groups
Experimental Treatment
Group I: SmartAlbuExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
688 Previous Clinical Trials
374,656 Total Patients Enrolled
4 Trials studying Diabetes
23,990 Patients Enrolled for Diabetes
Stephen N Davis, MBBSPrincipal InvestigatorUniversity of Maryland, Baltimore
3 Previous Clinical Trials
88 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You weigh enough for your height (BMI is not too low).The study is looking for 123 people who have either type 1 or type 2 diabetes.You have sickle cell disease, are pregnant, have hemoglobin disorders, or have kidney failure.We are excluding 53 people who do not have diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: SmartAlbu
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible for me to partake in this research endeavor?
"The clinical trial is seeking 176 individuals who have diabetes mellitus and are aged between 18-80 to take part. Additionally, 123 of the participants must have type 1 or 2 diabetes while 53 people can act as non diabetic controls. Furthermore, they must all possess a body mass index greater than 18.5kg/m2"
Answered by AI
What is the ceiling for potential participants in this trial?
"Affirmative. The online clinical trials registry showcases that this medical study is still recruiting patients and has been since August 2017. A total of 176 participants are needed from one site to complete the trial by April 2022."
Answered by AI
Is this investigation still recruiting participants?
"Confirmed. According to the clinicaltrials website, this trial began on August 24th 2017 and is still recruiting with its last update having been published April 8th 2022."
Answered by AI
Is admittance to this clinical experiment limited to individuals over the age of fifty?
"Eligibility criteria for this study necessitates that participants must be over 18 years old and younger than 80."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
What site did they apply to?
University of Maryland
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
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