Last updated on February 2020

Safety and Initial Performance of the DiaGone Device on Type 2 Diabetes Patients

Brief description of study

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.

Detailed Study Description

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.

Clinical Study Identifier: NCT03390322

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Prague, Czechia
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Recruitment Status: Open

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