Breath-Based Blood Glucose Monitoring Clinical Research Study
This page contains information about the clinical study on a breath-based blood glucose sensing device being developed by the Intelligent Systems Lab at Sonoma State University.
Prototype Breath Glucose Meter
About the Study
We are inviting you to participate in a research study in which we hope to learn correlations between finger-stick blood glucose (BG) measurements and breath sensor readings. It is being conducted by researchers Dr. Sudhir Shrestha (Associate Professor of Engineering) and Dr. Deborah Roberts (Professor of Nursing) of Sonoma State University. The device is a research-stage small portable sensor. When fully developed, it will estimate the blood glucose state from a patient’s breath. It has an opening for blowing into the sensors, and colored lights to indicate various statuses of the device, as well as a port for charging. When a patient blows into the sensor, some parameters of the chemical sensors change, and the device records those parameters.
Volunteers will be selected if they are an adult with diagnosed type-2 diabetes. The study will not ask for personal information and will contain procedural safeguards to protect your privacy. Your participation will be completely voluntary. If you decide to participate, Dr. Deborah Roberts will train you, give you a demo, and hand over the sensor device during one of your regular visits. With your participation, you will help us achieve the study’s goal of developing a new way to monitor and track blood glucose using breath. However, there are no direct benefits to you. Currently, we are not able to provide any compensation for this study. There is no added cost to you. The sensor device will be provided to you free of charge. You will receive a brand new device fabricated at the Intelligent Systems Lab at SSU. Used devices are not reused or retained. Upon return of the devices from participant, they will be discarded after resetting and deleting all digital information.
How to Conduct a Test with the Device
Contact for Patients and Questions about the Study
Patients should contact Dr. Deborah Roberts by email at email@example.com (Director of Clinical Services at Jewish Community Free Clinic, Professor at Sonoma State University, Co-investigator in the research).
Questions about the study and sensors should be directed to Dr. Sudhir Shrestha via email at Sudhir.Shrestha@sonoma.edu (Director of the Intelligent Systems Lab, Associate Professor at Sonoma State University, Principal investigator in the research).
Institutional Review Board (IRB) Information
Sonoma State IRB, IRB #3128
Title: Non-Invasive Glucose Monitoring using Breath Volatile Organic Compounds
Approval Effective Dates: 7/28/2020 through 7/28/2022
If you have a question about your rights as a human subject, contact firstname.lastname@example.org or phone (707)664-2066
Frequently Asked Questions (FAQs)
What is this device? It is a research stage, a small portable sensor device. When fully developed, it will estimate blood glucose state (high, normal, or low) from a patient’s breath.
How does it work? Human breath contains chemical fingerprints of blood glucose states. The device has chemical sensors that read the chemical fingerprints.
Why is this study needed and how does this study help the research: To correlate a chemical sensor reading to a specific blood glucose state, the device needs prior knowledge of how sensor responses correspond to blood glucose levels. Current prior knowledge is derived from the tests with simulated breath representing various blood glucose levels. The simulated breath samples were created based on many studies conducted in the past with breath samples from patients with diabetes collected in plastic bags and analyzed in laboratories. This study is needed to create more robust prior knowledge of the device and to learn how the device performs in actual use situations. The data gathered from this study will help the research create the dataset necessary to create a model that can work in real-life situations. This study is critical for this research to move to the next stage.
What does the device look like and what information does it record? The device is approximately 1.5” x 1” x 6”. It has an opening for blowing into the sensors, and colored lights to indicate various statuses of the device, as well as a port for charging. When a patient blows into the sensor, some parameters of the chemical sensors change, and the device records those parameters.
How does a patient use it? How long does it take for a test? How often do I need to charge it: Please refer to the User Manual that is included with the device.
How often does a patient test with the device? How does using the device affect a patient’s current treatment plan? Patients are asked to blow into the device each time they test their blood glucose readings using finger-stick glucometers, or twice a day if using a continuous glucose monitoring device, and record the glucose readings on a worksheet. This study does not change your current treatment plan. The current device does not display any results.
What information is being collected? Are there any privacy concerns? Patient identifying information will not be collected. The device only records the sensor readings and the time and date of a test. The healthcare practitioner will de-identify the worksheet by removing the patient’s information from the worksheet before sending it to the research lab. The patient’s age, gender, ethnicity, glucose readings, and the times and dates of the readings will be sent. Patients can request not to include age, gender, and ethnicity information.
How is the data gathered? What if I don’t have Wi-Fi? At the end of each test, the device wirelessly sends the data to a remote storage site managed by the research group. There is no need for a Wi-Fi connection. The device uses mobile towers to send the data. A health practitioner will collect the worksheets and send them to the research lab.
Is the Intellectual Property (IP) of the device protected? Yes, the intellectual property of the device is protected by a pending patent application. Please contact Dr. Shrestha for more information.
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