Revita™ T2D US Study
The Revita™ T2D US study is investigating a new approach to type 2 diabetes, attempting to address a potential root cause of the disease. Current treatment options focus on managing elevated blood sugar levels. The Revita™ T2D US study will assess the safety and effectiveness of a procedure called duodenal mucosa resurfacing (DMR) to see if it may be able to help the body control type 2 diabetes.
The part of the small intestine immediately after the stomach is called the duodenum. The innermost layer of the duodenum, called the mucosa, has an important role in controlling the body’s blood sugar level. Modifying the function of the mucosa may help improve the control of type 2 diabetes. The DMR procedure being investigated in the Revita™ T2D US study will involve an endoscopic procedure that makes targeted changes to the duodenum — the uppermost part of the small intestine. A heated-balloon is used to modulate the function of the intestinal lining without surgery or medicines.
Who can participate?
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 to three 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.
What will happen during the study?
After signing the consent form, you will begin your study participation with a screening visit that includes detailed medical assessments. In total, your study participation could last up to 60 weeks and include as many as 9 to 12 visits to the study site. The study doctor will determine if you qualify to continue in the study at each of the first 3 visits (screening visit, baseline visit, endoscopy and procedure visit).
If you undergo the endoscopy and DMR procedure at the third visit, the study doctor will discuss any anticipated restriction of activities and diet with you. Subsequent visits will be scheduled approximately 4 to 8 weeks apart. Between visits, the study staff will call to see how you are doing. The informed consent form includes details of what will happen during each visit or phone call.
To help with assessing the Revita™ DMR procedure, results will be compared to the results of a sham procedure. The sham procedure is similar to the real procedure but leaves out the heating, which is the key therapeutic element. In this study, you will be treated with either the Revita™ DMR procedure or the sham procedure. The procedure will be selected randomly (by chance, like drawing straws) for each participant, with 2 of 3 (67%) receiving the Revita™ DMR procedure and 1 of 3 (33%) receiving the sham procedure. Participants will be told which procedure they had 6 months after the procedure, at which point those who had the sham procedure can choose to have the Revita™ DMR procedure.
Participation in the Revita™ T2D US study is completely voluntary. A participant may choose to leave the study at any time, for any reason.
Study participant responsibilities
The Revita™ T2D US study depends on the cooperation of study participants. As a participant, you will need to follow the instructions of your study doctor and:
- Attend all visits and telephone calls as scheduled.
- Take your antidiabetic medications as instructed.
- Test your blood glucose at the specified times daily as instructed.
- Record your blood glucose and medications in your patient diary.
- Fast prior to tests and procedures as instructed.
- Follow a healthy lifestyle with diet and exercise.
- Follow the specified diet for the 14 days after the procedure.
- Provide honest answers to all questions asked by the study doctor and staff.
Print this page to share the study information with your doctor and discuss if study participation may be right for you.
Answer a few questions to see if you may qualify for the Revita™ T2D US clinical research study testing the investigational DMR procedure designed to elevate your body’s potential for better blood sugar control.