CGM for Type 2 Diabetes

(CMGProject Trial)

Overseen By Thomas Grace, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Blanchard Valley Health System

Must not be taking: Glucocorticoids

Disqualifiers: Pregnancy, Renal disease, Visual impairment, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether real-time continuous glucose monitoring (RT-CGM) can help people with Type 2 diabetes manage their blood sugar more effectively than traditional finger-prick tests. Participants will use the Dexcom G6 CGM to determine if it improves blood sugar levels and quality of life. It suits those with Type 2 diabetes who regularly see a doctor, have high blood sugar levels (A1C of 7.7% or more), and aim to lower their A1C to around 7%. Participants should be willing to wear a sensor and not have recently used a personal CGM. As an unphased trial, this study provides an opportunity to explore innovative ways to manage diabetes and enhance quality of life.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. However, if you are using glucocorticoids (a type of steroid) that affect blood sugar, you may not be eligible unless the dose is stable. It's best to discuss your specific medications with the trial team.

What prior data suggests that this device is safe for patients with Type 2 Diabetes?

A previous study showed promising safety results for the Dexcom G6 Continuous Glucose Monitor (CGM). This small device provides real-time blood sugar readings, aiding in more effective diabetes management. Some safety notes include avoiding use during procedures like MRI or CT scans. However, for everyday use, users generally tolerate it well.

The FDA has approved the device for managing diabetes, indicating a strong safety record. Participants in earlier studies demonstrated significant improvements in diabetes control without major safety issues. Overall, the Dexcom G6 is considered safe, but consulting a healthcare provider for any concerns is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Dexcom G6 CGM is unique because it continuously monitors glucose levels in real-time, offering a more dynamic way to manage Type 2 Diabetes compared to traditional methods like fingerstick blood tests. This real-time continuous glucose monitoring allows for more precise and timely adjustments to diet, exercise, and medication, potentially improving overall glycemic control. Researchers are excited about this technology because it could significantly enhance the quality of life for patients by reducing the guesswork in managing diabetes and providing immediate feedback that can lead to better long-term health outcomes.

What evidence suggests that using RT-CGM is effective for improving glycemic outcomes in Type 2 Diabetes?

Research has shown that the Dexcom G6 continuous glucose monitor (CGM) can significantly improve blood sugar control for people with type 2 diabetes. In one study, participants using a CGM saw their A1C levels, which measure average blood sugar over time, drop from 8.4% to 6.9% after three months. Another study reported a 2.4% decrease in A1C over six months. These findings suggest that CGMs like the Dexcom G6, which all participants in this trial will receive, can help people manage their diabetes more effectively by providing real-time blood sugar information. This tool could be particularly beneficial for those not meeting their blood sugar goals with traditional monitoring methods. ^{3 6 7 8 9}

Who Is on the Research Team?

Thomas Grace, MD

Principal Investigator

Hancock County Health Department

Are You a Good Fit for This Trial?

Adults with Type 2 Diabetes not meeting their A1C goals (A1C ≥7.7%) despite regular doctor visits and a desire to improve control are eligible for this trial. They must be willing to wear a continuous glucose monitor (CGM) and have stable diabetes management, as judged by the investigator. Pregnant individuals, those with certain medical conditions or severe allergies to adhesives, and anyone using CGMs in the last 3 months are excluded.

Inclusion Criteria

Followed regularly by a physician with at least 2 office visits in last year as documented by clinical history

I have been diagnosed with type 2 diabetes.

My blood sugar control is poor, with an A1C level of 7.7% or higher.

Exclusion Criteria

Current participation in another investigational study within the last 30 days

I have been using a real-time CGM device for the last 3 months.

Any condition per investigator assessment that could impact reliability of the A1C measurement

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Prescreening period

Treatment

Participants receive real-time continuous glucose monitoring (RT-CGM) and basic CGM education

12 months

Visits every 3 months for CGM supplies and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dexcom G6 CGM

Trial Overview The study is testing if real-time continuous glucose monitoring (RT-CGM) can better manage blood sugar levels compared to standard self-monitoring in people with Type 2 Diabetes who aren't reaching their target A1C levels. It also looks at how RT-CGM affects quality of life.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

All participants will be given a rtCGM (Dexcom G6) to assess their glycemic control.

Who Is Running the Clinical Trial?

Blanchard Valley Health System

Lead Sponsor

Trials

1

Recruited

200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11929555/

Clinical outcomes of a real‐world prospective study using ... This study assessed real‐world glycaemic outcomes associated with the use of Dexcom ONE in adults with suboptimally controlled diabetes.

2. provider.dexcom.com provider.dexcom.com/dexcom-community-glucose-monitoring-project-six-month-results-using-continuous-glucose-monitoring-0

Six-Month Results Using Continuous Glucose Monitoring ... Participants using a glucose sensor (n=237) showed clinically meaningful and statistically significant (p<0.001) decrease in A1C of 2.4%+1.9% at 6 months.

3. diabetesjournals.org diabetesjournals.org/clinical/article-pdf/42/4/540/787035/diaclincd240030.pdf

The Dexcom Community Glucose Monitoring Project: 6-Month ... Greater CGM use in the primary care setting among people with type 2 diabetes may help patients successfully manage their diabetes. The number of patients with ...

4. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.70008

Continuous glucose monitoring in noninsulin‐treated type 2 ... In a study of 47 non-insulin users, Reed et al. found that 3 months of G6 use was associated with significant decreases in mean HbA1c (8.4%–6.9 ...

5. dexcom.com dexcom.com/en-gb/press-releases/dexcom-showcases-leadership-in-aid

Dexcom Showcases Leadership in AID And Power of ... New data shows long-term use of an AID system powered by Dexcom CGM can safely maintain improvements in glycaemic outcomes for up to two ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8252147/

Safety and Functional Integrity of Continuous Glucose ... Wearable G6 components are labeled as “MR Unsafe” and are contraindicated for magnetic resonance imaging (MRI), computed tomography (CT), and diathermy.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8323182/

Accuracy of Dexcom G6 Continuous Glucose Monitoring in ... In a prospective study of 97 insulin-treated patients with type 2 diabetes, CGM (blinded FreeStyle Libre) showed overall lower mean glucose values than POC ...

8. dexcom.com dexcom.com/en-us

Dexcom Continuous Glucose Monitoring Dexcom Continuous Glucose Monitoring is simplifying diabetes management with a small device, accurate real-time glucose readings, and proven results.

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 ...