The Revitalize-1 Study will look at a potential procedure called duodenal mucosal resurfacing (DMR). The DMR procedure acts on the first layer (mucosa) of the duodenum (the part of the small intestine located immediately after the stomach). By removing an excess layer, the treatment may improve blood sugar control. This treatment may eliminate or reduce the need for insulin injections in the future.
After the procedure, you will be asked to stop taking insulin until the study doctor says you should start taking it again.
The Revitalize-1 Study will consist of three periods:
(up to 6 weeks)
This will consist of 3 study visits at the study center or your home. It is during this period that it is determined if the study is suitable for you. The study doctor may adjust your dose of insulin during this period.
Day of Procedure
You will visit the study center to have the procedure.
(about 11 months)
This will consist of 6 study visits at the study center or your home. You will also receive 5 phone calls. It is during this period that your progress will be monitored. The study doctor will further adjust your medications during this period.