What side effects are associated with this type of intervention?

Common treatments for abdominal obesity include lifestyle interventions and pharmacologic therapies. Lifestyle interventions, such as diet and exercise, generally have minimal side effects but may include temporary discomfort or fatigue. Pharmacologic treatments, such as GLP-1 receptor agonists (e.g., liraglutide, semaglutide), can cause gastrointestinal side effects like nausea and vomiting. Other medications like orlistat may lead to gastrointestinal issues such as oily stools and flatulence. Continuous Glucose Monitoring (CGM) itself is generally well-tolerated, with potential minor skin irritation at the sensor site.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity, including abdominal obesity. Notably, GLP-1 receptor agonists such as liraglutide and semaglutide have been approved for weight management. These drugs not only help in reducing weight but also improve glycemic control, making them relevant for patients with type 2 diabetes. Liraglutide (Saxenda) and semaglutide (Wegovy) have shown significant weight loss in clinical trials. These treatments align with the concept of using real-time glucose data to facilitate behavioral changes, as they help patients manage their weight and glucose levels more effectively.

What other types of research exist?

Promising novel alternatives to Continuous Glucose Monitoring (CGM) for facilitating behavioral change in abdominal obesity patients include telemedicine interventions, mobile health (mHealth) platforms, and gastric electrical stimulation. These methods provide real-time feedback and support, helping patients adhere to lifestyle changes necessary for managing abdominal obesity.

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Continuous Glucose Monitoring for Metabolic Health

N/A

Recruiting

Research Sponsored by Signos Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years and above

Be older than 18 years old

Must not have

Inborn errors of metabolism such as phenylketonuria (PKU), glycogen storage disease, fructose intolerance, Maple Sugar Urine Disease (MSUD)

History of Gastric bypass or other bariatric surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years.

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a device that tracks blood sugar levels and a mobile app to help non-diabetic people improve their weight and health. By monitoring their blood sugar, users can learn which foods and activities are best for them, with the app providing personalized advice.

Who is the study for?

This trial is for adults who can read English, own a smartphone to use the Signos App, and are willing to input data and complete surveys. It's not for those with Type 1 or Type 2 Diabetes, history of bariatric surgery, severe diseases that limit diet/exercise, certain medication users, or those with eating disorders.

What is being tested?

The study tests if using a Continuous Glucose Monitor (CGM) device helps non-diabetic people lose weight when combined with the Signos mobile health platform through coaching and nutrition education.

What are the potential side effects?

Potential side effects may include skin irritation from the CGM device adhesive. However, since this is a non-invasive monitoring tool in a generally healthy population, significant side effects are not commonly expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a genetic disorder like PKU or MSUD.

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I have had gastric bypass or another weight-loss surgery.

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I have been diagnosed with Type 1 Diabetes.

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I do not have a severe illness like COPD or heart disease that would stop me from following diet or exercise plans.

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I have been diagnosed with Type 2 Diabetes.

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I have had 10 or more skin infections like cellulitis.

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I have or had an eating disorder and my current BMI is under 24.

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I am currently taking medication for diabetes or using Hydroxyurea or insulin.

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I follow a specific medical diet due to a condition like epilepsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and during enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average fasting glucose

Change in weight

Secondary study objectives

Body composition

Time in range

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Signos digital health app and CGMExperimental Treatment1 Intervention

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

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for abdominal obesity include lifestyle changes, pharmacologic therapy, and metabolic surgery. Lifestyle changes, such as dietary modification and increased physical activity, help reduce caloric intake and improve insulin sensitivity, leading to weight loss and better glycemic control. Pharmacologic therapies, like anti-obesity medications, work by suppressing appetite or inhibiting fat absorption. Metabolic surgeries, such as gastric bypass, alter the digestive system to limit food intake and nutrient absorption. Continuous Glucose Monitoring (CGM) plays a crucial role by providing real-time glucose data, which helps patients make informed dietary and activity choices, thereby facilitating behavioral changes and improving adherence to weight management plans. This is particularly important for abdominal obesity patients as it directly impacts insulin resistance and metabolic health.

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