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.
Sequential
pulsENDO Therapy
DeviceThe pulsENDO System is a catheter-based, non-thermal endoscopic therapy designed to promote controlled regeneration of the duodenal mucosa using pulsed electric field (PEF) technology. The treatment is controlled by the design of electrodes and waveform algorithm that concentrates the field to target the doudenal and jejunal cells of the small intestines.
Change in HbA1c
Change in HbA1c from baseline to Month 6
Percent Change in HbA1c from baseline to Month 12
Percent Change in HbA1c from baseline to Month 12 in treatment arm only
Number o participants with HbA1c ≤7.0% at Month 6
Proportion of participants achieving HbA1c ≤7.0% without requiring rescue medication at Month 6
Time-in Tight Range (TITR) at Month 6
Number of participants with Time-in Tight Range (TITR) ≥50% at Month 6
Total body weight loss (%TBL)
Percent total body weight loss (%TBWL) from baseline to Month 6
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