RESET System for Type 2 Diabetes and Obesity
This study is testing the RESET System, a device designed to help manage type 2 diabetes and obesity. It's for people aged 22 to 65 with type 2 diabetes, an HbA1c (a measure of blood sugar over time) between 7.5% and 10%, and a BMI (Body Mass Index) between 30 and 50. The study aims to see if the RESET System can significantly improve blood sugar control and if it is safe to use. Success will be measured by the change in HbA1c after 9 months. The study is currently recruiting 264 participants, but its overall status is unclear.
- Study design
- This is a randomized, double-blinded study comparing the RESET System to a sham procedure. Participants will be randomly assigned to receive either the RESET System or a sham treatment, with three times as many people getting the RESET System.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint for measuring change in HbA1c is at 9 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
RESET System Pivotal Trial (Rev F)
At a glance
Conditions
Where it's being run
7 sites across 7 statesStudy leadership
- Christopher C Thompson, MD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital
Who to contact
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What this trial measures
- Change in HbA1c9 Months
Change in HbA1c value from baseline to 9 months.