Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT04838392
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-01
First Post:
2021-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness and Safety of the RIGHTEST Continuous Glucose Monitoring System for Blood Glucose Management in Persons With Diabetes Mellitus
Sponsor:
Bionime Corporation
Organization:
Study Overview
Official Title:
Effectiveness and Safety of the RIGHTEST Continuous Glucose Monitoring System for Blood Glucose Management in Persons With Diabetes Mellitus
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: