NCT06197906

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Bionime Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The trial is expected to enroll 120 confirmed cases of type 1 or type 2 diabetes. All eligible subjects must wear a continuous glucose monitoring system on both the left and right upper arms for a maximum of 15 days (360 hours) and adhere to the clinical visit protocol. The entire trial process consists of pre-screening visits, 5 clinical visits, and 1 telephone follow-up. After enrollment, all subjects will be randomly assigned to either Group A or Group B to determine the time points for clinical visits. Group A subjects will have venous blood drawn on days 1 and 10 (±1) post-wearing, while Group B subjects will have venous blood drawn on days 5 (±1) and 15 (-1) post-wearing. All subjects will remove all devices on day 15 (-1) based on system prompts and undergo a telephone follow-up on day 4 (±3) thereafter. This clinical trial does not involve long-term follow-up. During the trial, the blood glucose values measured by the "continuous glucose monitoring system" worn by the subjects will be analyzed against the EKF venous blood glucose values measured at the medical institution on days 1, 5 (±1), 10 (±1), and 15 (-1) as control reference values. This analysis aims to evaluate the accuracy, repeatability, stability, high and low blood glucose event alerts, and safety of the continuous glucose monitoring system. Additionally, fingertip blood glucose measurements taken by subjects during home use will be collected to assess the operational feasibility of the continuous glucose monitoring system in a home setting.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Device implant	subcutaneous device implanting

Timeline

• Start date: 2024-05-01
• Primary completion: 2024-09-01
• Completion: 2024-10-01
• First posted: 2024-01-09
• Last updated: 2024-01-09