Using Signos mHealth Platform in Adults for Weight Management

NCT06214221 | Active Not Recruiting FDA Device

• 1 other identifier: SIGNOS-CGM-SWEET-301-2023
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 5

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.

Conditions

Overweight and Obesity; Metabolic Syndrome; Weight Loss

Outcome Measures

Primary Outcomes (2)

• Responder Rate

  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%)

  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

Study Arms (2)

Signos System

EXPERIMENTAL

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

Standard Lifestyle Education

ACTIVE COMPARATOR

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

Interventions

Signos System DEVICE

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.

Signos System

Standard Lifestyle Education OTHER

In the "Standard Lifestyle Education" arm, participants receive conventional advice on diet and exercise, focusing on general healthy lifestyle habits to manage weight.

Standard Lifestyle Education

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Signos Inc: lead
• Lindus Health, Inc.: collaborator

Study Sites (5)

Helios Clinical Research (Phoenix)

Phoenix, Arizona, 85028, United States

Location

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

Segal Trials

North Miami, Florida, 33161, United States

Location

Helios Clinical Research

Houston, Texas, 77008, United States

Location

Seattle Clinical Research

Seattle, Washington, 98105, United States

Location

Related Publications (14)

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MeSH Terms

Conditions

Overweight; Obesity; Metabolic Syndrome; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Body Weight Changes

Study Officials

• Stephanie Kim, MD

  Signos Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Trial Investigator, Signos Inc

Model Details: In an open-label randomization model, participants and researchers both know the treatment each participant is receiving. This model involves randomly assigning participants to different treatment groups, ensuring unbiased distribution across interventions, but without concealing the nature of the treatment from either the participants or the study team.

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 19, 2024
• Study Start: January 2, 2024
• Primary Completion: December 31, 2024
• Study Completion: April 30, 2026
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)