Continuous Glucose Monitoring for Metabolic Health

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Signos Inc

Must not be taking: Insulin, Sulfonylureas, Hydroxyurea, others

Disqualifiers: Diabetes, Eating disorders, Chronic diseases, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

If you are currently taking Hydroxyurea, insulin, sulfonylureas, or medications prescribed specifically for diabetes, you cannot participate in this trial. Otherwise, the protocol does not specify if you need to stop other medications.

What data supports the effectiveness of the treatment Continuous Glucose Monitor Device?

Continuous glucose monitors (CGMs) have been shown to help people with diabetes better manage their blood sugar levels by providing real-time data and alerts for high or low blood sugar. Studies indicate that CGMs can improve blood sugar control without increasing the risk of dangerously low blood sugar levels. ^{1 2 3 4 5}

Is continuous glucose monitoring safe for humans?

Continuous glucose monitors (CGMs) have been associated with a significant number of adverse events, with 281,963 reported in 2022 for people with diabetes. While CGMs can help manage blood sugar levels, users should be aware of potential risks, such as inaccurate sensor readings, which can affect safety. ^{1 5 6 7 8}

How is continuous glucose monitoring different from other treatments for metabolic health?

Continuous glucose monitoring (CGM) is unique because it provides real-time, continuous tracking of glucose levels, allowing for immediate adjustments and better control of blood sugar without increasing the risk of low blood sugar episodes. Unlike traditional methods, CGM offers alarms for rapid changes and predictions of high or low blood sugar, making it a more dynamic and responsive tool for managing metabolic health. ^{1 7 8 9 10}

Research Team

Eligibility Criteria

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.

Inclusion Criteria

I own a smartphone and agree to use the Signos App for the study.

Able to speak and read English

Willingness to complete questionnaires or other surveys

Exclusion Criteria

Inability or unwillingness of subject to give informed consent

I have a genetic disorder like PKU or MSUD.

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Signos app and CGM to receive personalized health and wellness recommendations

5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

• Continuous Glucose Monitor Device (Continuous Glucose Monitor)

Trial Overview 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.

Participant Groups

Group I: Signos digital health app and CGM Experimental Treatment 1 Intervention

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Signos Burlingame, CA

Signos Palo Alto, CA

Who Is Running the Clinical Trial?

Signos Inc

Lead Sponsor

Trials

3

Patients Recruited

120,000+

Findings from Research

The new-generation continuous glucose monitoring system, Dexcom G4 PLATINUM (DG4P), demonstrated significantly better accuracy than the previous generation, with a mean absolute relative difference (MARD) of 13% compared to 16% for the Dexcom SEVEN PLUS (DSP).

DG4P also showed improved reliability, with 90% of its sensors achieving a MARD of ≤ 20%, compared to only 76% for DSP, suggesting that the enhanced performance of DG4P could lead to better glycemic control and increased adoption of CGM technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new-generation continuous glucose monitoring system: improved accuracy and reliability compared with a previous-generation system. Christiansen, M., Bailey, T., Watkins, E., et al.[2022]

Continuous glucose monitors (CGMs) have been shown to provide accurate glucose readings, making them a reliable tool for individuals with diabetes and their healthcare providers.

Recent clinical trials highlight the practical benefits of CGMs, demonstrating their effectiveness in managing diabetes and improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Implications of Accuracy Measurements of Continuous Glucose Sensors. Bailey, TS.[2018]

The new continuous glucose monitoring (CGM) system demonstrated strong accuracy over a 10-day period, with a mean absolute relative difference of 9.6%, indicating reliable glucose readings for users.

With 99.6% of measurements categorized as 'no' or 'slight' risk for discrepancies compared to self-monitored blood glucose values, this CGM system supports its use in diabetes management without the need for adjunctive testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stability, Accuracy, and Risk Assessment of a Novel Subcutaneous Glucose Sensor. Hughes, J., Welsh, JB., Bhavaraju, NC., et al.[2019]

Continuous glucose monitoring (CGM) devices are now widely available in the U.S. for both consumer purchase and research, providing a new tool for diabetes management.

CGM technology allows for real-time monitoring of glucose levels, which can help individuals manage their diabetes more effectively, as well as enabling retrospective analysis of glucose data for better long-term management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical overview of continuous glucose monitoring. Buckingham, B.[2021]

Continuous glucose monitoring (CGM) significantly improves glycemic control in diabetes patients compared to traditional monitoring methods, helping to reduce both the frequency and severity of hypoglycemic episodes.

CGM technology plays a crucial role in the development of the 'artificial pancreas', highlighting its importance in advancing diabetes management and treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Performance of Continuous Glucose Monitoring: An Overview. Singh, H., Venkatesan, V.[2023]

Continuous glucose monitoring (CGM) technology is crucial for assessing glucose metabolism in diabetes, helping to evaluate treatment outcomes and guide therapy.

The article reviews the advancements, potential benefits, and challenges associated with CGM, highlighting its importance for both patients and healthcare providers in managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring in China: Then, now and in the future. Jia, W.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring: current use and future directions. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A new-generation continuous glucose monitoring system: improved accuracy and reliability compared with a previous-generation system. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Clinical Implications of Accuracy Measurements of Continuous Glucose Sensors. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Continuous glucose monitors: the long-awaited watch dogs? [2007]

5. Ireland pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring: A review of the technology and clinical use. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse Event Causes From 2022 for Four Continuous Glucose Monitors. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Stability, Accuracy, and Risk Assessment of a Novel Subcutaneous Glucose Sensor. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Clinical overview of continuous glucose monitoring. [2021]

9. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Safety and Performance of Continuous Glucose Monitoring: An Overview. [2023]

10. Japan pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring in China: Then, now and in the future. [2018]