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

March 5, 2024 updated by: Stephanie Kim, M.D., MPH, Signos Inc

A Randomized Controlled Trial Evaluating the Safety and Effectiveness of the Intelligently-Driven Signos System for Personalized Weight Management in Overweight and Obese Adults

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

380

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Sharam Fouladgar-Mercer
  • Phone Number: (650) 263-4502
  • Email: sharam@signos.com

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85028
        • Helios Clinical Research (Phoenix)
    • California
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research
    • Florida
      • North Miami, Florida, United States, 33161
        • Segal Trials
    • Texas
      • Houston, Texas, United States, 77008
        • Helios Clinical Research
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Signos System
For all consented participants, the Signos app will use CGM data to provide recommendations customized to users for promoting general health and wellness.
Device: Signos System
The intervention involves the use of the Signos System, a combination of a proprietary software application with a continuous glucose monitor (CGM), to manage weight in overweight and obese adults.
Active Comparator: Standard Lifestyle Education
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.
Other: Standard Lifestyle Education
In the "Standard Lifestyle Education" arm, participants receive conventional advice on diet and exercise, focusing on general healthy lifestyle habits to manage weight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Responder Rate
Time Frame: 6 Months
Investigators will measure how many participants successfully reached their weight management goals by the end of 6 months. This 'Responder Rate' tells us the percentage of people in our study who effectively managed their weight using the methods we provided, whether it's through the Signos System or standard lifestyle education.
6 Months
Average Total Body Weight Loss (TBWL%)
Time Frame: 6 Months
Investigators will measure how much weight, on average, participants have lost after 6 months in the study. This will be calculated as a percentage of their initial weight. This measure helps us understand the effectiveness of the Signos System in helping participants reduce their body weight over a 6-month period.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Signos Inc

Collaborators

Lindus Health, Inc.

Investigators

  • Study Chair: Stephanie Kim, MD, Signos Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

January 9, 2024

First Submitted That Met QC Criteria

January 9, 2024

First Posted (Actual)

January 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIGNOS-CGM-SWEET-301-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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