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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

Summary

This trial looks at how CGM and mHealth platforms can help people with obesity, pre-diabetes, and diabetes make changes to diet and exercise to improve health.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average fasting glucose
Change in weight
Secondary outcome measures
Body composition
Time in range

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.

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.
Is there a path for approval of an antiobesity drug: what did the Sibutramine Cardiovascular Outcomes Trial find?

Find a Location

Who is running the clinical trial?

Signos IncLead Sponsor
2 Previous Clinical Trials
20,380 Total Patients Enrolled

Media Library

Signos digital health app and CGM Clinical Trial Eligibility Overview. Trial Name: NCT05121844 — N/A
Abdominal Obesity Research Study Groups: Signos digital health app and CGM
Abdominal Obesity Clinical Trial 2023: Signos digital health app and CGM Highlights & Side Effects. Trial Name: NCT05121844 — N/A
Signos digital health app and CGM 2023 Treatment Timeline for Medical Study. Trial Name: NCT05121844 — N/A
~45763 spots leftby Nov 2026