NCT04964752

A Study of the Continuous Glucose Monitoring System for Home Use in Patients With Diabetes

Effectiveness and Safety Study of the Continuous Glucose Monitoring System for Home Use (Including In-clinic Sessions) in Patients With Diabetes

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Subjects in the upper arm group will have a sensor of the CGM System inserted on each arm (left and right upper arm). Subjects in the abdomen group will have 2 sensors inserted, one on each side of the abdomen (left and right abdomen) The sensors will be placed for 29 days. After sensor insertion, the CGM system should be calibrated with capillary blood glucose readings from a self-monitoring blood glucose meter。

Conditions

• Diabetes

Interventions

Type	Name	Description
DEVICE	continuous glucose-monitoring	Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes.

Timeline

• Start date: 2021-07-30
• Primary completion: 2022-02-28
• Completion: 2022-04-30
• First posted: 2021-07-16
• Last updated: 2021-07-16