Using Signos mHealth Platform in Adults for Weight Management (SWEET)

Signos

Status: Active, not recruiting

Conditions: Weight Loss; Overweight and Obesity; Metabolic Syndrome

Treatments: Other: Standard Lifestyle Education; Device: Signos System

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06214221

SIGNOS-CGM-SWEET-301-2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 380 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

To join our study, participant need to:

• Be at least 22 years old.
• Be overweight or obese, which we define as having a Body Mass Index (BMI) between 25 and 40.
• HbA1c test result should be below 6.5% at the start of the study.
• Have and know how to use a smartphone that's compatible with the Signos app.
• Be able to understand, speak, and read English well enough to participate fully in the study.

Exclusion criteria

Participant can't join our study if participant has:

• Have Type 1 or Type 2 diabetes.
• Are already using a device to monitor glucose level.
• Have severe allergies to the sticky part of glucose monitors.
• Suffer from an eating disorder like anorexia or bulimia.
• Are currently taking certain medications for diabetes or weight loss.
• Have had or are planning to have weight loss surgery.
• Have major health issues like severe kidney disease, untreated thyroid problems, or skin conditions where the glucose monitor would be placed.
• Have been part of another clinical trial recently.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

380 participants in 2 patient groups

Signos System

Experimental group

Description:

For all consented participants, the Signos app will use CGM data to provide recommendations customized to users for promoting general health and wellness.

Treatment:

Device: Signos System

Standard Lifestyle Education

Active Comparator group

Description:

The "Active Comparator: Standard Lifestyle Education" arm in the clinical trial refers to a control group that receives conventional lifestyle modification advice instead of the experimental Signos System.

Treatment:

Other: Standard Lifestyle Education