This clinical trial is for men or women who have inadequately controlled Type 2 diabetes and are currently on stable doses of basal insulin. The purpose of this study is to learn more about the use of the Fractyl Revita System for the treatment of Type 2 diabetes for individuals who are on insulin therapy.
     
The study device, the Revita System, has not been approved for use by the Food and Drug Administration (FDA) in the United States since the device is experimental. The Revita System is commercially available in the United Kingdom. 

We believe modifying the function of a layer of the small intestine may improve the control of diabetes. The Fractyl Revita System will be used on the first layer (mucosa) of the duodenum. This process is called duodenal mucosal resurfacing (DMR).
   
There are two phases (non-randomized and randomized) in this study. In the non-randomized phase, participants will receive the DMR. In the randomized phase, participants will be randomly placed in a study group by chance. The Duodenal Mucosal Resurfacing (DMR) procedure using the study device will be compared to a sham procedure. The sham procedure is similar to the DMR procedure, but leaves out the heating, which is the key therapeutic element of the DMR procedure. In this study, participants will undergo the DMR procedure (using the Revita System) or the sham procedure. Participants have one out of two chances (1:1) of being placed in either of the groups. About 11 months (Week 48) after the procedure, participants will be told which procedure they received at the beginning of the study. If participants received the sham procedure, they will be offered the opportunity to receive the DMR procedure.
   
Participants in the non-randomized phase will be in the study for 1 year. Participants who have been randomized will be in this study for approximately 24 months (2 years).
   
Participants will be compensated for their time.