Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06214221
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-01-09
Brief Title:
Using Signos mHealth Platform in Adults for Weight Management
Sponsor:
Signos Inc
Organization:
Signos Inc
Study Overview
Official Title:
A Randomized Controlled Trial Evaluating the Safety and Effectiveness of the Intelligently-Driven Signos System for Personalized Weight Management in Overweight and Obese Adults
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
SWEET
Brief Summary:
Metabolic syndrome and resulting downstream health effects remains a growing health concern In published trials the use of continuous glucose monitoring CGM assists behavioral changes efforts leading to improved adherence and results from diet and exercise changes in individuals with obesity Mobile health mHealth platforms provide satisfactory easy-to-use tools that help participants in the pursuit of weight change goals The investigators hypothesize that the use of CGM data and targeted coaching and nutrition education will assist with weight optimization goals in the general non-diabetic population using the Signos mHealth platform with associated health benefits
Detailed Description:
The scope of this study is to enroll participants into a study that utilizes a continuous glucose monitor CGM and mobile health application Signos to optimize general wellness and body weight and composition The Signos users will be compared against a control arm
Study Oversight
Has Oversight DMC:
None
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?:
True
Is an FDA AA801 Violation?:
None