This is a prospective, multicenter, randomized, double-blind, sham-controlled, adaptive study evaluating the pulsENDO system in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications (GLMs). The primary objective of this study is to demonstrate that pulsENDO therapy is superior to sham control for improving glycemic control in adults with type 2 diabetes.
22- 75 years of age, inclusive.
T2D diagnosis for at least 6 months.
HbA1c of 7.5-10.5%, inclusive, for participants on 1-3 GLMs or or if on 4 glucose-lowering medications must have HbA1c between 7.5% - 9.0%, inclusive.
BMI 27-40 kg/m2, inclusive.
Diagnosed with type 1 diabetes.
History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
Fasting serum C-peptide <1 ng/mL (333pmol/l).
Current use of insulin, or previous use of any types of insulin for >1 month at any time (except for treatment of gestational diabetes) in last 2 years.