Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-25 @ 8:11 PM
Study NCT ID:
NCT05874635
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-29
First Post:
2023-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Signos DM2 Empowerment Study (SIGNOS-CGM-EMPOWER-201-2022)
Sponsor:
Signos Inc
Organization:
Study Overview
Official Title:
Use of Signos mHealth Platform in Participants With Non-Insulin Dependent Type 2 Diabetes: Weight and Blood Glucose
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
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 use of continuous glucose monitoring (CGM) in earlier data has inspired behavioral changes leading to improved adherence to an exercise plan in individuals and eating habits in people with diabetes. Mobile health (mHealth) platforms provide satisfactory, easy-to-use tools to help participants in the pursuit of weight change goals. We hypothesize that the use of CGM data and the Signos mHealth platform will assist with weight control in a population of people with type 2 diabetes mellitus who are not using insulin.
Detailed Description:
The scope of this study is to enroll existing and new Signos non-insulin dependent type 2 diabetes mellitus users in a volunteer study that utilizes a continuous glucose monitor (CGM) and mobile health application \[Signos\] to optimize general wellness and body weight and composition. This is a no more than minimal risk study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: