Continuous Glucose Monitoring for Type 2 Diabetes

Overseen By Study Administration

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Signos Inc

Must not be taking: Clozapine, Hydroxyurea, Insulin

Disqualifiers: Type 1 diabetes, Eating disorders, 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 explores how continuous glucose monitoring (CGM) can aid weight management in people with type 2 diabetes. Participants use the Signos app with the CGM device to receive personalized advice on health, exercise, and eating habits. The trial targets individuals with type 2 diabetes who do not use insulin and are open to lifestyle changes. Participants should be comfortable using a smartphone app and willing to track their progress through surveys. As an unphased trial, it provides a unique opportunity to explore innovative methods for managing diabetes and improving overall health.

Will I have to stop taking my current medications?

The trial requires that you do not take Clozapine, Hydroxyurea, or any form of insulin. If you are currently taking any of these, you would need to stop before participating.

What prior data suggests that the Continuous Glucose Monitor Device is safe for use in people with type 2 diabetes?

Research shows that continuous glucose monitoring (CGM) devices are generally safe for people with diabetes. These devices track blood sugar levels in real time and are worn on the body. Studies have found that most users find CGMs comfortable and that they provide useful information without major problems.

However, a few considerations are important. Certain medical tests, like MRIs, can affect the sensor, so knowing when to remove the device is crucial. People using CGMs for other health conditions have not reported serious issues, suggesting they are safe for people with type 2 diabetes who are not using insulin.

Overall, CGMs serve as a useful tool for managing diabetes, with minimal risk for most users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about continuous glucose monitoring (CGM) for Type 2 diabetes because it offers a dynamic and personalized approach to managing blood sugar levels. Unlike traditional methods that rely on periodic finger-prick tests, CGM provides real-time data, allowing individuals to track their glucose levels continuously throughout the day and night. This constant monitoring can lead to more personalized and timely adjustments in diet and lifestyle, potentially improving overall health and wellness. The integration with the Signos digital health app further enhances the experience by analyzing CGM data to provide tailored health recommendations, making diabetes management more proactive and user-friendly.

What evidence suggests that the Continuous Glucose Monitor Device is effective for weight control in type 2 diabetes?

Research has shown that using a Continuous Glucose Monitor (CGM) helps people with type 2 diabetes manage their blood sugar more effectively. Studies have found that a CGM can slightly lower HbA1c levels, a measure of average blood sugar over time, and increase the time spent with blood sugar in a healthy range. This trial will incorporate the Signos digital health app with the CGM to provide customized recommendations for promoting general health and wellness. This technology offers real-time feedback, aiding users in making better food and exercise choices. By observing how daily activities affect blood sugar, individuals can adjust their habits, potentially improving weight control and overall health. ^{4 5 6 7 8}

Who Is on the Research Team?

Stephanie Kim, MD

Principal Investigator

Signos Inc

Are You a Good Fit for This Trial?

This trial is for adults with Type 2 Diabetes who are not using insulin. Participants must be willing to use a Continuous Glucose Monitor (CGM) device, engage with the Signos mHealth platform on their smartphone, and have medical clearance to make diet and lifestyle changes. They should not have severe hypoglycemia history, certain metabolic disorders, an eating disorder, or be taking specific medications like Clozapine.

Inclusion Criteria

Be a Signos mHealth (mobile/web-based) user

I have been diagnosed with Type 2 Diabetes based on my latest Hg A1c test results.

Able to speak and read English

Exclusion Criteria

I have been diagnosed with Type 1 Diabetes.

I have been diagnosed with an eating disorder like anorexia or bulimia.

You have had a bad skin reaction to adhesive in the past.

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 CGM device along with the Signos mobile health platform can help people with Type 2 Diabetes manage their weight better by promoting exercise and healthy eating habits. It's based on previous findings that suggest monitoring glucose levels can inspire beneficial behavioral changes.

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.

Continuous Glucose Monitor Device is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Continuous Glucose Monitor Device for:

• Diabetes management
• Monitoring of glucose levels in individuals with diabetes

Approved in United States as Continuous Glucose Monitor Device for:

• Diabetes management
• Monitoring of glucose levels in individuals with diabetes
• Adjunctive use in the management of type 1 and type 2 diabetes

Approved in Canada as Continuous Glucose Monitor Device for:

• Diabetes management
• Monitoring of glucose levels in individuals with diabetes

Approved in Japan as Continuous Glucose Monitor Device for:

• Diabetes management
• Monitoring of glucose levels in individuals with diabetes

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 Monitoring (CGM) devices, including real-time (rtCGM) and intermittently scanned (isCGM), significantly improve glucose control and reduce hypoglycemia in insulin-treated individuals with diabetes, based on recent clinical evidence.

An updated algorithm was developed to help healthcare providers choose the most suitable CGM device for different clinical scenarios, such as type 1 and type 2 diabetes, pregnancy, and frailty, ensuring a personalized approach to diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An updated algorithm for an effective choice of continuous glucose monitoring for people with insulin-treated diabetes. Maiorino, MI., Buzzetti, R., Irace, C., et al.[2023]

The new seventh-generation (G7) continuous glucose monitoring (CGM) device significantly reduces the number of tasks required for deployment compared to the sixth-generation (G6), making it easier for older adults and diabetes care specialists to use.

With a high usability score of 92.8, the G7 CGM device is reported to have a low cognitive burden, which may lead to better diabetes management outcomes for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability and Teachability of Continuous Glucose Monitoring Devices in Older Adults and Diabetes Educators: Task Analysis and Ease-of-Use Survey. Psavko, S., Katz, N., Mirchi, T., et al.[2023]

The continuous glucose monitoring system (CGMS) demonstrated high test-retest reliability in measuring glucose levels in individuals with type 2 diabetes, with relative reliability scores ranging from 0.77 to 0.95 for various glycemic measures.

Specific measures of glycemic variability, such as standard deviation (SD(w)) and mean amplitude of glycemic excursions (MAGE), showed significant reliability, indicating that CGMS can be effectively used in clinical trials for monitoring glucose levels over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Test-retest reliability of a continuous glucose monitoring system in individuals with type 2 diabetes. Terada, T., Loehr, S., Guigard, E., et al.[2022]

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]

The Eversense continuous glucose monitoring (CGM) system demonstrated long-term safety with no related serious adverse events reported among 3023 patients over multiple sensor insertion-removal cycles, totaling 1260 patient-years of follow-up.

The most common minor adverse events included site infections and irritation, but these occurred at low rates, indicating that the Eversense CGM system is generally well-tolerated in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Safety of an Implantable Continuous Glucose Sensor Over Multiple Cycles of Use: A Post-Market Registry Study. Deiss, D., Irace, C., Carlson, G., et al.[2020]

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]

The Eversense continuous glucose monitoring (CGM) system, which features a fully implantable sensor with a lifespan of up to 180 days, has shown a mean absolute relative difference (MARD) of 8.5% to 9.4%, indicating good accuracy in glucose monitoring.

Clinical trials reported no serious device-related adverse events, with minor issues such as site irritation (0.66%) and infection (0.96%), suggesting that the Eversense system is safe for long-term use in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device profile of the eversense continuous glucose monitoring system for glycemic control in type-1 diabetes: overview of its safety and efficacy. Irace, C., Cutruzzolà, A., Tweden, K., 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]

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 monitoring systems provide real-time glucose readings from interstitial fluid, significantly improving diabetes management for both type 1 and type 2 diabetes patients.

These systems help patients and healthcare providers analyze glucose patterns, leading to better glycemic control, reduced hemoglobin A1c levels, and fewer instances of hypoglycemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring for the Internist. Lee, GS., Lupsa, BC.[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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37987208/

Effectiveness of Continuous Glucose Monitoring on Metrics ... Moderate certainty of evidence indicated that use of CGM had a modest but statistically significant reduction in HbA1c levels of about 0.32%.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10460137/

The Effectiveness of Continuous Glucose Monitoring ... The results of our study demonstrated that the adoption of CGM device leads to significant improvements in glycemic control, as evidenced by a ...

3. nature.com nature.com/articles/s41598-024-83548-4

Continuous glucose monitoring among adults with type 2 ... Patients showed improvements in time in range (39.7–61.9%, p < 0.0001), time > 180 mg/dL (60.1–37.9%, p < 0.001), time > 250 mg/dL (27.6–8.5%, p ...

4. diabetesjournals.org diabetesjournals.org/clinical/article/43/1/139/157329/Continuous-Glucose-Monitoring-in-Individuals-With

Continuous Glucose Monitoring in Individuals With Type 2 ... The use of CGM in the population of people with type 2 diabetes has been shown to improve patients' ability to use real-time glycemic ...

5. diabetes.org diabetes.org/advocacy/cgm-continuous-glucose-monitors

Continuous Glucose Monitoring (CGM) People with type 1 and type 2 diabetes who use a CGM have fewer instances of hypoglycemia and a lower A1C. Obstacles to Accessing CGMs. Image. CGM Advo l2. One ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10658671/

Safety and Functional Integrity of Continuous Glucose ... This study is a comprehensive evaluation of the effects of common radiologic procedures of CT, X-ray scanning, and MRI on the glucose sensor components.

7. 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 ...

8. my.clevelandclinic.org my.clevelandclinic.org/health/articles/continuous-glucose-monitoring-cgm

Continuous Glucose Monitoring (CGM): What It Is A continuous glucose monitor (CGM) is a wearable device that tracks your glucose (sugar) levels in real time. It's a tool people with diabetes use.