To evaluate the safety and performance of the BALANCE System in treating patients who have type 2 diabetes and are overweight. Impact on blood glucose levels, weight loss, blood pressure and other clinical and metabolic parameters will be studied.
The BALANCE System stimulates the duodenum in a specialized way to strengthen the natural contractions and mimic the sensation of fullness (satiety). The patient is expected to feel full after eating smaller amounts of food than normal. In addition, duodenal stimulation has been shown to induce favorable changes in postprandial glucose levels, glucose tolerance testing and insulin levels. The target population type II diabetic patients uncontrolled with oral medications, and with overweight (BMI \>30). The Balance System may overcome the known disadvantages of insulin therapy and allow early treatment of these patients, potentially preventing the progression of obesity and diabetes.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The BALANCE System stimulates the duodenum in a specialized way to strengthen the natural contractions and mimic the sensation of fullness (satiety). The patient is expected to feel full after eating smaller amounts of food than normal. In addition, duodenal stimulation has been shown to induce favorable changes in postprandial glucose levels, glucose tolerance testing and insulin levels.
University Clinic Hamburg-Eppendorf (UKE)
Hamburg, Germany
Evaluation of the of device and/or procedure related adverse events
Time frame: 12 months
Significant decrease in the HbA1c values from baseline
Time frame: at week 4, and at month 2,3,4,5,6,8,10,12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.