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Blood Glucose Monitoring System User Evaluation

See if you qualify for our study by filling out the form below

XYZ Diabetes Test .jpeg

We are currently looking for Pre-diabetic and Diabetic participants over 18. Please complete the form to apply for the clinical trial. Please share this screening form with your friends and family.

Participants will be compensated $75.00 for their time and travel.  

It is a Single, 1-Hour office visit.

Please call our office for more details at 737-320-4972.

​​The purpose of this study is to assess the clinical performance of a new type of BGMS (Blood Glucose Monitoring System).  There is NO medication involved with this study.

Participants will perform self-testing following the manufacturer's instructions and fill out a short survey regarding the product's usability.  A medical professional will collect another sample from the participant for a comparator test that will be performed at a laboratory. 

Clinical Trial Screening
Are you 18 Years of AGE or over?
Have previously Used a Self-Monitoring Blood Glucose (SMBG) meter before?
Have you ever had a Syncopal episode (faint) during a blood draw?
Do you have a known bleeding disorder?
Are you afraid of needles or having your blood drawn?
Do you have abnormal hematocrit levels in your blood?
Do you have any other blood disorders or conditions?

We have a second location that will be accepting patients starting on Tuesday, 5/14, this site located at 7801 N Lamar Blvd B-159, Austin, TX 78752. We have appointments available at this site on Tuesdays from 8 AM to 11 AM and Sundays from 8 AM to 4 PM, only.

1. Objective of the study

This study aims to evaluate the performance of a self-glucose monitoring system in the hands of lay users.

 

2. Inclusion & Exclusion Criteria

  • Inclusion Criteria:

    • Able to provide informed consent.

    • Able to read and understand English.

    • Diabetic and prediabetic patients who have used or have never used SMBG before.

    • Individuals with different educational backgrounds (approximately 14% above college, 34% college, 15% some college, 28% high school and 9% below high school).

  • Exclusion Criteria:

    • Unable to provide written informed consent.

    • Unable to read and understand English.

    • Had a known bleeding disorder, fear of needles, or known difficulties in giving finger prick blood.

    • Individuals with abnormal hematocrit levels in their blood (<15% or >60%).      

    • Individuals with experience working as medical laboratory professionals.    

 

3. Study Procedures (This study includes a single visit)

  • Informed consent: A study staff member will go over the informed consent form with the potential participant, addressing any questions or concerns they may have. The participant will then provide consent to participate.

  • Demographic information collection: The study staff will gather demographic data from participants, including age, race, education level, previous experience with the glucose monitoring system, health status, and medications.

  • Self-testing: Participants will perform self-testing using the study device, following the manufacturer’s instructions provided in the manual

  • .Comparator test: Following self-testing, the study staff will collect a finger-prick blood sample from the participant for the comparator test.

  • Hematocrit level testing: The study staff will test the participant's hematocrit level using finger prick blood.

  • Usability survey: Participants will be asked to complete a usability survey regarding their experience with the glucose testing system.

Home Continuous Glucose Monitoring Training
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