STEP-1-A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Evaluating the RESET® System for Glycemic Improvement For 2 Diabetes and Obesity
A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Evaluating the RESET® System for Glycemic Improvement in Patients with Inadequately Controlled Type 2 Diabetes and Obesity, the STEP-1 Study
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Clinical Trial Information
Trial Contact: Morales, Leticia; Hernandez-Pagan, Gloryvee
Trial Phone: 321.841.9623 ; 321-843-8910
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IRB No: 25.145.06
Protocol Abbrev: STEP-1
Principal Investigator: Andre F. Teixeira, MD
Phase: Device: Phase III
Age Group: Adult
Secondary Protocol No: 18-1
Treatment: This is a multi-center, double-blinded, randomized, sham-controlled trial to evaluate the safety and effectiveness of the RESET System plus moderate intensity lifestyle and dietary counseling compliant with 2024 American Diabetes Association Standard of Care as compared to a sham control receiving the same moderate intensity lifestyle and dietary counseling. Patients will be randomized 3 (RESET):1 (Sham).
Therapies Involved: Procedural
ClinicalTrials.gov ID: NCT04101669
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Objective
1)To determine if the RESET System significantly improves glycemic control
2) To determine that the RESET System can be safely used to improve glycemic control -
Key Eligibility
1. Age ≥ 22 years and ≤ 65 years
2. Have understood and signed the approved informed consent form
3. Diagnosis of type 2 diabetes
4. HbA1c ≥ 7.5% and ≤ 10%
5. BMI ≥ 30kg/m2 and ≤ 50kg/m2
6. Willing and able to comply with study requirements
7. Documented negative pregnancy test in women of childbearing potential
8. Women of childbearing potential not intending to become pregnant (continue to be on an approved form of birth control) for the duration of their trial participation, including post explant period. Women of child-bearing age without known sterilization will be placed on 1 form of birth-control to prevent unwanted pregnancies
9. At least one year of medical records available, including detailed medical therapy and dosing information
10. Failed to achieve adequate HbA1c reduction (<7.5%) after at least dual therapy for at least 3-month stable dosage of diabetes medication(s), including insulin, metformin, SGLT-2 inhibitor, GLP-1 RA, Dual GLP-1/GIPR agonist, meglitinides, sulfonylureas, thiazolidinediones, or DPP-4s.. Patients will be required to discontinue sulfonylureas on the day of randomization.
