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Blood Glucose Monitoring System User Evaluation

XYZ Diabetes Test .jpeg

We are currently looking for  individuals over 18 with diabetes or prediabetes for a quick, one-time glucose meter user evaluation study lasting under an hour. No medications or invasive procedures involved. Participants will be compensated $75.00 for their time and insights.  

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​​The purpose of this study is to assess the clinical performance of a new type of BGMS (Blood Glucose Monitoring System).  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 finger prick blood sample (~10 drops of blood) from the participant for a comparator test that will be performed at a laboratory. 

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.

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