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

20000 Participants Needed

Trial Summary

What is the purpose of this trial?

The use of continuous glucose monitoring (CGM) in earlier data has inspired behavioral changes leading to improved adherence to an exercise plan in individuals and eating habits in people with diabetes. Mobile health (mHealth) platforms provide satisfactory, easy-to-use tools to help participants in the pursuit of weight change goals. We hypothesize that the use of CGM data and the Signos mHealth platform will assist with weight control in a population of people with type 2 diabetes mellitus who are not using insulin.

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 data supports the effectiveness of the treatment Continuous Glucose Monitor Device for Type 2 Diabetes?

Research shows that continuous glucose monitoring (CGM) helps people with diabetes, including type 2, by providing detailed information about their blood sugar levels. This helps them manage their condition better, leading to improved blood sugar control and reduced risk of low blood sugar episodes. ^{1 2 3 4 5}

Is continuous glucose monitoring safe for humans?

Continuous glucose monitoring (CGM) systems are generally safe for humans, with a large study showing no serious related adverse events over multiple uses. Some minor issues like sensor site infections and skin irritation can occur, but they are relatively rare. ^{2 5 6 7 8}

How is continuous glucose monitoring different from other treatments for type 2 diabetes?

Continuous glucose monitoring (CGM) is unique because it provides real-time, continuous tracking of glucose levels, allowing for better management of blood sugar without increasing the risk of low blood sugar episodes. Unlike traditional methods that require finger-prick blood tests, CGM uses a sensor to measure glucose in the fluid under the skin and can alert users to changes in glucose levels. ^{1 9 10 11 12}

Research Team

Stephanie Kim, MD

Principal Investigator

Signos Inc

Eligibility Criteria

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

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

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.

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.

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+

Findings from Research

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) 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]

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]

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, 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 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 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]

References

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

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

2. Ireland pubmed.ncbi.nlm.nih.gov

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

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

Continuous Glucose Monitoring for the Internist. [2022]

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

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

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

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

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

Clinical overview of continuous glucose monitoring. [2021]

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

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

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

Real-World Safety of an Implantable Continuous Glucose Sensor Over Multiple Cycles of Use: A Post-Market Registry Study. [2020]

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

An updated algorithm for an effective choice of continuous glucose monitoring for people with insulin-treated diabetes. [2023]

10. England 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. [2022]

11. Canada 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. [2023]

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

Test-retest reliability of a continuous glucose monitoring system in individuals with type 2 diabetes. [2022]