Summary:
Do you have uncontrolled type 2 diabetes?
Full management of type 2 diabetes using antidiabetic oral medications (OADs) can be frustrating and time consuming. The Revita System is a potential new type 2 diabetes treatment procedure that is not a pill or an injection.
Based on new discoveries in metabolic science, the investigational Revita™ duodenal mucosal resurfacing (DMR) procedure targets the upper intestine, or duodenum, with the aim of addressing a root cause of insulin resistance in type 2 diabetes. It is intended as an outpatient therapy that can be performed in approximately one hour and allows patients to resume normal activities the following day.
What is the purpose of the Revita™ T2D US study?
The purpose of this study is to learn more about using the Revita™ System to conduct a duodenal mucosa resurfacing (DMR) procedure for people with type 2 diabetes.
Is study participation an option for me?
You may be able to participate in the Revita™ T2D US study if you:
- Are 28–65 years of age
- Have been diagnosed with type 2 diabetes for at least 3 years
- Have a body mass index (BMI) between 28 and 40
- Are on two oral antidiabetic medications (OADs), one of which is metformin
- Are willing and able to attend study visits and undergo study procedures and assessments
- Are not diagnosed with Type 1 Diabetes (T1D)
- Are not currently using injectable medications for diabetes (insulin, GLP-1RA)
There are other factors that could determine if you may qualify for the Revita™ T2D US study. A study doctor will discuss preliminary requirements with you and explain the study schedule and procedures in detail. If you meet preliminary requirements and want to join the study, you will need to review the informed consent form thoroughly. You should ask the study doctor any questions to help you understand all aspects of the study and what will be expected of you as a participant. If all your questions and concerns have been addressed, you will need to sign the consent form before undergoing any study procedures.