Continuous Glucose Monitoring for Metabolic Health

Not currently recruiting at 1 trial location

Overseen By Study Administration

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Signos Inc

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

Disqualifiers: Diabetes, Eating disorders, Chronic diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 5 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a continuous glucose monitor (CGM) and a digital health app can help individuals improve their weight and overall health. It targets adults seeking to optimize their weight through better diet and exercise, even if they are not diabetic. Participants will track their glucose levels using the CGM and receive personalized recommendations via the Signos app. This trial suits those who own a smartphone, speak English, and are interested in using technology to achieve their weight goals. As an unphased trial, it offers a unique opportunity to explore innovative technology for weight management.

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 prior data suggests that this continuous glucose monitoring device is safe for metabolic health?

Research shows that continuous glucose monitors (CGMs) are generally safe, but potential risks exist. In 2022, 281,963 problems with CGMs were reported. Most involved device malfunctions, but 13,644 cases involved injuries, and 9 deaths occurred. Some CGMs, such as the FreeStyle Libre 3 sensor, have been recalled due to inaccurate readings, which can be concerning.

Inserting the sensor into the skin can sometimes cause local infection, inflammation, pain, or bleeding. Despite these risks, many people use CGMs without major issues, and they are approved for monitoring glucose levels in people with diabetes. Awareness of these possible side effects is important, and consulting a healthcare provider before starting use is recommended. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using continuous glucose monitors (CGMs) alongside the Signos digital health app because it offers a personalized approach to metabolic health that current standard options, like fingerstick blood tests and basic diet recommendations, can't match. This treatment stands out by providing real-time glucose monitoring and customized health recommendations, empowering users to make instant lifestyle changes based on their unique data. Unlike traditional methods, which often involve retrospective analysis, this combination of technology allows for proactive management of glucose levels, potentially leading to better overall health and wellness.

What evidence suggests that the Continuous Glucose Monitor Device is effective for metabolic health?

Research shows that using a continuous glucose monitor (CGM) can help people manage their health, even without diabetes. Studies have found that CGMs provide real-time information, enabling healthier choices like improved eating habits and increased exercise. This can lead to better weight management and overall health. For people with diabetes, CGMs help control blood sugar levels, suggesting potential benefits for those without diabetes as well. In this trial, participants will use the CGM device with the Signos digital health app, which utilizes CGM data to offer customized health and wellness recommendations. The CGM device constantly checks glucose levels, providing users with ongoing feedback to guide their health decisions. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Glucose Monitor Device

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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

Signos Inc

Lead Sponsor

Trials

3

Recruited

120,000+

Published Research Related to This Trial

Continuous glucose monitoring (CGM) technology allows for real-time tracking of glucose levels, helping users manage their blood sugar more effectively without increasing the risk of hypoglycemia.

Key challenges for CGM include ensuring sensor accuracy, reliability, and comfort, which are essential for advancing towards artificial pancreas systems that automate blood sugar management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring: current use and future directions. DeSalvo, D., Buckingham, B.[2022]

Continuous glucose monitors (CGMs) have been developed and are available, but their widespread use in diabetes care is still limited due to insufficient evidence of their effectiveness in improving glycemic control for most type 1 diabetes patients.

Current studies show a lack of controlled trials demonstrating significant impacts of CGMs on important health metrics like hemoglobin A1c and hypoglycemia frequency, highlighting the need for future research to focus on patient outcomes and the overall effectiveness of CGMs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitors: the long-awaited watch dogs? Wentholt, IM., Hoekstra, JB., Devries, JH.[2007]

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]

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]

In 2022, there were 281,963 reported adverse events related to continuous glucose monitors (CGMs), highlighting a significant safety concern for people with diabetes.

The analysis of adverse events for four CGM products revealed that common issues included inaccuracy and device malfunctions, indicating a need for improved monitoring and device reliability to enhance user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Event Causes From 2022 for Four Continuous Glucose Monitors. Krouwer, JS.[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]

Continuous glucose monitoring (CGM) significantly improves diabetes management for insulin-requiring patients, particularly in type 1 diabetes, by providing real-time insights into glycemic fluctuations and allowing for better lifestyle and medication adjustments.

The review highlights that CGM can lead to improved hemoglobin A1c (A1C) levels, reduced hypoglycemia, and enhanced quality of life, suggesting its potential benefits for broader patient populations with proper education and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring: A review of the technology and clinical use. Klonoff, DC., Ahn, D., Drincic, A.[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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12061739/

Advances in Continuous Glucose Monitoring: Clinical ...

Recent evidence supports its effectiveness in both type 1 and type 2 diabetes management, with benefits extending beyond traditional glucose ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05121844

Study Details | NCT05121844 | Use of Continuous Glucose ...

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

3.

thrombosis.org

thrombosis.org/patients/patient-articles/continuous-glucose-monitoring-for-non-diabetics-a-new-frontier-in-metabolic-health-optimization

Continuous Glucose Monitoring for Non Diabetics

As a wearable sensor, the device continuously tracks glucose data in real time, providing users with actionable health information. The ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1871403X25001176

A mixed-methods cross-sectional study

Continuous glucose monitoring (CGM) is increasingly used by people with and without diabetes to support lifestyle change.

5.

nature.com

nature.com/articles/s41598-024-56933-2

Metabolic health tracking using Ultrahuman M1 continuous ...

In this study, we acquired glycemic variability (GV) using the Ultrahuman (UH) M1 CGM, and activity metrics via the Fitbit wearable for Indians/South Asians.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11688675/

Adverse Event Causes From 2022 for Four Continuous ...

For the year 2022, CGMs had a total of 281 963 adverse events with 268 310 malfunctions, 13 644 injuries, and 9 deaths.

7.

fda.gov

fda.gov/medical-devices/medical-device-recalls-and-early-alerts/continuous-glucose-monitoring-cgm-sensor-recall-abbott-diabetes-care-inc-issues-recall-certain

CGM Sensor Recall: Abbott FreeStyle Libre 3 Sensors

FreeStyle Libre 3 sensor provides continuous monitoring of glucose levels but a small number of sensors may give inaccurate high readings.

8.

freestyle.abbott

freestyle.abbott/us-en/safety-information.html

Safety Information | The FreeStyle Libre System

Read safety information regarding your FreeStyle Libre 14 day system, including MRI contraindications, insulin contraindications, and sensor removal ...

9.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf12/P120005S018b.pdf

FDA - Summary of Safety and Effectiveness Data (SSED)

The following events are possible adverse device effects of inserting a sensor into your skin: local infection, inflammation, pain or discomfort, bleeding ...

10.

newsweek.com

newsweek.com/dexcom-g7-cgm-glucose-monitor-reports-issues-10932888

'It's Life-Threatening'—Dexcom G7 Users Say Glucose ...

Dexcom is facing scrutiny and class-action lawsuits over alleged safety and accuracy issues with its G7 monitor.