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. 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 ADA Standard of Care as compared to a sham control receiving moderate intensity lifestyle and dietary counseling. Both the treatment and sham group will practice medical management compliant with STEP-1 Study Guidelines. Patients will be randomized 3 (RESET):1 (Sham).
The objective of this study is to evaluate the safety and effectiveness of the RESET System when used with moderate intensity lifestyle and dietary counseling and medical management, in patients with baseline HbA1c ≥ 7.5% and ≤10%, and BMI ≥ 30 kg/m2 and ≤ 50kg/m2, whose diabetes medications consist of at least dual therapy for 3 months, yet have not achieved adequate HbA1c control (\<7%). Specific objectives of this study are: 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
264
The RESET System is provided as a single-use, sterile device and consists of an RESET Liner preloaded, packaged and sterilized within the RESET Delivery System. The RESET Delivery System is utilized to deliver the RESET Liner to the proximal small intestine. The RESET Liner is removed using the RESET Retrieval System. The RESET System incorporates no pharmacological, biological tissue or blood products.
Patient receives upper endoscopy but no treatment
MedStar Health Research Institute
Washington D.C., District of Columbia, United States
RECRUITINGUniversity of Miami Hospital
Miami, Florida, United States
RECRUITINGBrigham and Women's Hospital
Boston, Massachusetts, United States
RECRUITINGMichigan Medicine, Division of Gastroenterology and Hepatology
Ann Arbor, Michigan, United States
RECRUITINGWeill Cornell Medicine
New York, New York, United States
RECRUITINGCleveland Clinic
Cleveland, Ohio, United States
RECRUITINGBaylor College of Medicine
Houston, Texas, United States
RECRUITINGChange in HbA1c
Change in HbA1c value from baseline to 9 months.
Time frame: 9 Months
HbA1c value
Proportion of patients who achieve an HbA1c value of \< 7 %
Time frame: 9 and 21 months
Weight Loss
Proportion of patients who achieve percent total body weight loss ≥ 5% from baseline
Time frame: 9 and 21 months
Insulin use
Proportion of patients reducing insulin dosage
Time frame: 9 and 21 months
LDL cholesterol
Chnage in LDL cholesterol
Time frame: 9 and 21 months
Triglycerides
Change in triglycerides
Time frame: 9 and 21 months
Blood pressure
Change in systolic blood pressure values
Time frame: 9 and 21 months
Fasting blood glucose level
Change in fasting blood glucose values
Time frame: 9 and 21 months
Vitamin D
Change in vitamin D levels
Time frame: 9 and 21 months
Vitamin D Supplementation
Average vitamin D levels required to maintain normal vitamin D levels
Time frame: 9 and 21 months
Refractory to Vitamin D Supplementation
Proportion of patients refractory to vitamin D supplementation
Time frame: 9 and 21 months
Serum Creatinine
Change in serum creatinine levels
Time frame: 9 and 21 months
eGFR
Change in eGFR levels
Time frame: 9 and 21 months
Change in Nonalcoholic Fatty Liver Disease (NAFLD)
Change in NAFLD, change in % liver fat using MRI (proton density fat fraction)
Time frame: 9 and 21 months
Change in Nonalcoholic Steatohepatitis (NASH)
NASH- liver fibrosis % compared to baseline using using MRE measured in kPa
Time frame: 9 and 21 months
DTSQ Questionnaire
Change from baseline in treatment satisfaction using Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Time frame: 9 and 21 months
IWQOL Questionnaire
Impact of weight on quality of life (IWQOL)
Time frame: 9 and 21 months
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