FAQ: What are the risks associated with this Levels Research?
FAQ:
What are the risks associated with this Levels Research?
Answer:
While the study CGM has been FDA cleared for use in persons approved with T1D **, it has not been approved for use in the general population. It does not present a potential for serious risk to your health, safety, or welfare. However, there are minor risks that go along with participating in this study. The chance of these risks occurring is low.
These risks are described below:
- If you are taking a prescription medication that impacts your glucose or insulin for any reason, you acknowledge that behavior changes you might engage in by participating in this trial may impact your prescription and your health, and may present a risk to you.
- It is possible, though unlikely, that the adhesive of the CGM in contact with the skin may cause local redness, inflammation (swelling), pain or discomfort, and itching if you are sensitive to this adhesive.
- Insertion of the sensor can cause local redness, inflammation (swelling), pain or discomfort, occasional bleeding, bruising, itching, scarring or skin discoloration, or hematoma (collection of blood outside of blood vessels).
- There is a chance of infection where the sensor is inserted.
- There is a remote risk that some part of the sensor could break during insertion, wear or removal, and get trapped under the skin.
- Participants may be contacted via phone, email, and SMS texts for study purposes. Communication by these means will not be encrypted potentially leading to inadvertent disclosure of your information.
- CGM devices like the study CGM are not meant to be used during X-ray, magnetic resonance imaging (MRI), computed tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. There are additional risks if you use the study CGM during any of these treatments.
- Your study data will be coded, and your identifying information (for example, name, address) will be replaced with a random code. The key that ties your code to you will be kept securely by Levels. While every effort will be made to protect your information, total privacy cannot be guaranteed, and a loss of confidentiality is a potential risk to study participation.
While the Terms of Use, End User License Agreement, or Privacy Policy may include statements limiting your rights if you are harmed as a result of your use of the app, eDiary, or device in this study, you do not release the study doctor, sponsor, institution, or agents for responsibilities from mistakes. You also do not waive any of your rights as a research participant.
In addition to these risks, there may be other risks that are unknown.