Continuous Glucose Monitor for Type 2 Diabetes

Overseen By Ryan Larson, PharmD, CPP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must be taking: Insulin

Disqualifiers: Gestational diabetes, Type 1 diabetes, others

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether using a continuous glucose monitor, which tracks blood sugar levels, along with support from a clinical pharmacist, can better manage type 2 diabetes in uninsured minority patients. It evaluates whether this approach improves health outcomes compared to standard doctor visits. Individuals who are Hispanic or non-Hispanic Black, have type 2 diabetes, have recently experienced high blood sugar levels, and use insulin daily may be suitable candidates. Participants will either receive the continuous monitor and additional support or continue with their regular health care routine. As an unphased trial, this study provides a unique opportunity to explore innovative diabetes management strategies that could enhance the health care experience.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since you need an active prescription for insulin and must inject at least once daily, it seems you will continue using insulin.

What prior data suggests that this continuous glucose monitor is safe for type 2 diabetes patients?

Research has shown that continuous glucose monitors (CGMs) are generally safe for people with diabetes. These devices track blood sugar levels in real time, leading to better health outcomes. The FDA approved CGMs like the Dexcom G4 PLATINUM, indicating they are well-tolerated. Users often experience fewer low blood sugar episodes and require fewer fingerstick tests. This makes managing diabetes easier and safer for most people. Overall, CGMs have a strong safety record based on current evidence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using continuous glucose monitors (CGMs) for managing Type 2 diabetes because they offer real-time tracking of blood sugar levels. Unlike standard care, which typically involves periodic blood tests and routine doctor visits every few months, CGMs provide continuous data, allowing for more precise management of blood sugar. This real-time feedback helps patients make immediate lifestyle or medication adjustments, potentially leading to better overall glucose control and reducing the risk of complications.

What evidence suggests that a continuous glucose monitor is effective for type 2 diabetes?

In this trial, participants in the intervention arm will receive a continuous glucose monitor (CGM) in addition to usual care. Studies have shown that using a CGM can greatly help people with type 2 diabetes manage their blood sugar levels. Research indicates that those using CGMs often experience fewer episodes of low blood sugar and see a reduction in their A1C levels, which measures average blood sugar over time. CGM users typically gain a better understanding of their blood sugar patterns in real-time, aiding in healthier lifestyle choices. Additionally, regular CGM use has been linked to significant health improvements and fewer doctor visits. Overall, CGMs are considered a breakthrough in effectively managing diabetes. ^{1 6 7 8 9}

Who Is on the Research Team?

Ryan Larson, PharmD, CPP

Principal Investigator

Myers Park Internal Medicine

Are You a Good Fit for This Trial?

This trial is for uninsured Hispanic or non-Hispanic Black individuals with type 2 diabetes, specifically those who have had an HbA1c level of 8% or higher in the past three months and are currently taking insulin injections at least once a day.

Inclusion Criteria

I am either Hispanic or non-Hispanic Black.

My HbA1c level has been 8% or higher in the last 3 months.

I have been diagnosed with Type 2 diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a continuous glucose monitor and pharmacist-led medication management services

6 months

At least 1 visit per month (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Glucose Monitor

Trial Overview

The study is testing whether using a continuous glucose monitor (CGM) along with support from a clinical pharmacist can better manage blood sugar levels in participants compared to usual care without these additional tools.

How Is the Trial Designed?

Group I: Continuous Glucose Monitor Experimental Treatment 1 Intervention

Patients in the intervention arm will receive a continuous glucose monitor in addition to usual care. These patients will be scheduled at least once monthly for clinical pharmacy visits.

Group II: Usual Care Active Control 1 Intervention

Patients in the usual care arm will have routine physician office visits every 3 months if HbA1c outside goal or every 6 months if HbA1c within goal. Medication regimens will be managed by physicians, nurse practitioners, and physician assistants.

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

Approved in United States as Continuous Glucose Monitor for:

• Type 1 Diabetes
• Type 2 Diabetes
• Insulin-treated Diabetes

Approved in European Union as Continuous Glucose Monitor for:

• Type 1 Diabetes
• Type 2 Diabetes
• Gestational Diabetes

Approved in Canada as Continuous Glucose Monitor for:

• Type 1 Diabetes
• Type 2 Diabetes

Approved in Japan as Continuous Glucose Monitor for:

• Type 1 Diabetes
• Type 2 Diabetes

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

American Society of Health System

Collaborator

Trials

1

Recruited

60+

American Society of Health-System Pharmacists

Collaborator

Trials

5

Recruited

330+

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) was analyzed in 53 diabetic patients, primarily those with type 1 diabetes (90.5%), and was found to be effective in detecting asymptomatic hypoglycemic events and guiding therapy changes in 64.5% of cases.

The method provided additional information that improved glycemic control and potentially life expectancy in type 1 diabetes patients, but it was noted to be less effective for type 2 diabetes patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The role of continuous glucose monitoring in the therapy of diabetes mellitus]. Bagosi, Z., Oroszlán, T., Bujtor, Z., 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]

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]

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]

The new continuous glucose monitoring system (CGMS) was well tolerated by 20 children with type 1 diabetes over 7 days, with 90% of sensors still in use at the end of the study, indicating good patient acceptance and safety.

The study found that the CGMS could effectively function beyond the typical 72-hour limit, with 78% of sensors still operational after 7 days, suggesting that the device can provide extended monitoring without significant loss of accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended use of a new continuous glucose monitoring system with wireless data transmission in children with type 1 diabetes mellitus. Wong, LJ., Buckingham, BA., Kunselman, B., et al.[2009]

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]

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 a 5-week pilot study involving 9 subjects with type 1 diabetes, continuous glucose monitoring led to a significant reduction in HbA1c from 9.9% to 8.8%, indicating improved glycemic control without changing daily insulin usage.

The continuous glucose monitors accurately identified glucose patterns, allowing for therapy adjustments that would not have been possible with traditional blood glucose meter data, suggesting a valuable tool for managing diabetes effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring used to adjust diabetes therapy improves glycosylated hemoglobin: a pilot study. Bode, BW., Gross, TM., Thornton, KR., et al.[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]

Citations

1.

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 ...

2.

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 ...

3.

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 ...

4.

jmcp.org

jmcp.org/doi/10.18553/jmcp.2024.24255

Initiating continuous glucose monitoring is associated with ...

This study showed that CGM use in patients with diabetes was associated with clinically meaningful improvements in A1c and reduced health care resource ...

5.

e-enm.org

e-enm.org/journal/view.php?number=2600

Advances in Continuous Glucose Monitoring: Clinical ...

Continuous glucose monitoring systems have revolutionized diabetes management, significantly improving glycemic control in both Type 1 and Type 2 diabetes.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8861781/

Demonstrating the Clinical Impact of Continuous Glucose ...

Participants using CGM devices had meaningful improvements in clinical outcomes, costs, and self-reported measures compared to the FSG group.

7.

accessdata.fda.gov

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

FDA - Summary of Safety and Effectiveness Data (SSED)

The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age ...

8.

diabetesjournals.org

diabetesjournals.org/care/article/47/1/169/154009/Efficacy-and-Safety-of-Continuous-Glucose

Efficacy and Safety of Continuous Glucose Monitoring and ...

Both CGM and isCGM demonstrated a reduction in HbA 1c levels in individuals with T2D, and unlike CGM, isCGM use was associated with improved user satisfaction.

9.

adces.org

adces.org/education/danatech/glucose-monitoring/continuous-glucose-monitors-(cgm)/cgm-101/pros-cons-of-cgm

CGM l Pros and Cons of Continuous Glucose Monitors ...

CGM provides continuous, real-time glucose data, eliminating the need for frequent fingerstick checks. It enhances hypoglycemia prevention, improves glycemic ...