NCT04838392

Effectiveness and Safety of the RIGHTEST Continuous Glucose Monitoring System for Blood Glucose Management in Persons With Diabetes Mellitus

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Bionime Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effectiveness and safety of the RIGHTEST Continuous Monitoring (CGM) System in adult population with diabetes mellitus.

Detailed description

This is a prospective, open-label, randomized, multicenter, single-arm pivotal study without control groups in up to 150 adult subjects with type 1 or type 2 diabetes mellitus who will be enrolled at 12 investigational sites in the United States. All subjects are required to wear 1 Sensor on the back of each upper arm for up to 15 days (up to 360 hours) and participate in 4 in-clinic visits. All subjects will have frequent venous blood draws to evaluate the blood glucose reference measurements in each in-clinic visit and collect accurate information against a laboratory reference method.

Conditions

• Diabetes Mellitus
• Type 1 Diabetes
• Type 2 Diabetes

Interventions

Type	Name	Description
DEVICE	RIGHTEST Continuous Glucose Monitoring System	RIGHTEST Continuous Glucose Monitoring System

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-07-01
• Completion: 2025-11-01
• First posted: 2021-04-09
• Last updated: 2024-08-01

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated device study