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.

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NCT04101669

RESET System Pivotal Trial (Rev F)

Recruiting
NAAges 22–65InterventionalTreatment
Morphic Medical Inc.
~264 participants
Updated 2024-07-18 on ClinicalTrials.gov
What's tested:RESET LinerSham

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in HbA1c
Measured over 9 Months
Diabetes type2
Obesity
7 sites across 7 states
District of Columbia1
Florida1
Massachusetts1
Michigan1
New York1
Ohio1
Texas1
  • Christopher C Thompson, MD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

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  • Change in HbA1c9 Months

    Change in HbA1c value from baseline to 9 months.