Diabetes Mellitus, Type 2
Conditions
Brief summary
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 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.
Interventions
DEVICEDiaGone™
Duodenal Glycemic Control™ using the DiaGone™ system
Sponsors
Digma Medical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who are ≥ 18 years and ≤ 75 years of age. * HbA1c at 7.5%-12% * On oral glucose lowering drugs in a stable medication regimen * Fasting plasma glucose level at ≥125mg/dL * BMI 25-40 Kg/m2
Exclusion criteria
* Diagnosed Type I diabetes * Serum C peptide \<1ng/ml
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of procedure related SAEs. | 7 days |
Secondary
| Measure | Time frame |
|---|---|
| Change to Fasting Glucose levels | 12 months |
| Change to Post Prandial Glucose levels | 12 months |
| Change to HbA1c levels | 12 months |
Countries
Czechia, Israel
Outcome results
None listed