This is a multi-center, prospective, open label study of the Duodenal Glycemic Control™ procedure on type 2 diabetes patients sub-optimally controlled, to examine the safety and initial performance of the DiaGone™ system.
This study is a multi-center, prospective, open label trial of type 2 diabetes patients sub-optimally controlled on at least one oral anti-diabetic medication. Subjects who meet all inclusion and exclusion criteria after screening are hospitalized and go through the Duodenal Glycemic Control™ treatment. Duodenal Glycemic Control™ treatment is conducted by a gastroenterologist, in an endoscopic suite, with an off-the-shelf endoscope, using the DiaGone™ system. Patients are followed for 6 months for AE and SAE. Patients are followed for 12 months for glycemic control parameters.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Duodenal Glycemic Control™ using the DiaGone™ system
IKEM
Prague, Czechia
Soroka Medical Center
Beersheba, Israel
Shaarei Tzedek
Jerusalem, Israel
Incidence of procedure related SAEs.
Time frame: 7 days
Incidence of procedure related SAEs.
Time frame: 6 months
Change to Fasting Glucose levels
Time frame: 12 months
Change to Post Prandial Glucose levels
Time frame: 12 months
Change to HbA1c levels
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.