Continuous Glucose Monitoring for Diabetes

Overseen By Adrian G Dumitrascu, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: Insulin

Must not be taking: Acetaminophen, Hydroxyurea, Ascorbic acid, Tetracycline

Disqualifiers: ICU admission, Liver cirrhosis, ESRD, others

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

Compensation: Varies

Number of Visits: 2

Duration: Up to 8 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the use of personal Continuous Glucose Monitors (CGMs) in hospitals to manage diabetes by guiding insulin therapy. It aims to improve blood sugar control and reduce extreme highs and lows, while maintaining satisfaction among patients and healthcare providers with the monitoring process. The trial includes two groups: one with real-time CGM data monitoring and another without it. It suits individuals with diabetes who already use a CGM and are hospitalized for more than two days. As an unphased trial, it provides a unique opportunity to contribute to innovative diabetes care research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention restrictions for certain medications if you are using specific glucose monitors. For example, if you use Medtronic or Dexcom sensors, you should not take more than 4g of acetaminophen per day, and if you use Libre sensors, you should not take over 500 mg of ascorbic acid.

What prior data suggests that continuous glucose monitoring is safe for hospital use?

Research has shown that continuous glucose monitors (CGMs) are generally safe for people with diabetes. Studies have found that using a CGM helps stabilize blood sugar levels, reducing both high and low episodes. This can lead to better overall health.

One study found that using a CGM not only improved health but also lowered healthcare costs for people with diabetes. Another study discovered that people using CGMs were more satisfied with their diabetes management. This suggests that CGMs are easy to use and simplify diabetes management.

Overall, these findings support the safety of CGMs for people with diabetes, as they demonstrate fewer complications and greater satisfaction with diabetes care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring how continuous glucose monitoring (CGM) can be used in hospitals to improve diabetes care. Unlike traditional glucose monitoring methods that require periodic finger pricks and don't provide real-time data, CGMs continuously track glucose levels and can alert healthcare providers to any dangerous fluctuations instantly. This real-time monitoring can potentially lead to more precise adjustments in treatment and better overall glucose control for patients admitted to the hospital. By comparing patients whose CGM data is actively monitored with those whose data is not, researchers hope to demonstrate the benefits of immediate intervention in glucose management.

What evidence suggests that using a personal continuous glucose monitor is effective for improving glycemic control in diabetes?

Research has shown that using a real-time continuous glucose monitor (CGM) can significantly help people with diabetes manage their blood sugar levels. Studies have found that CGMs can lower average blood sugar levels, known as HbA1c, and reduce the risk of very high or low blood sugar. Many CGM users report greater satisfaction with their diabetes management and experience better overall health outcomes. In this trial, participants will be divided into two groups: one group will have their CGM data monitored in real time, while the other group will wear a CGM without real-time monitoring. Evidence suggests that real-time monitoring with a CGM provides more accurate and timely information, aiding in more effective insulin use and improved diabetes care. These findings support the idea that CGMs are valuable tools for managing diabetes in various settings, including hospitals. ^{4 6 7 8 9}

Who Is on the Research Team?

Adrian G Dumitrascu, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for hospitalized individuals with Diabetes Mellitus who use a personal continuous glucose monitor (CGM). Participants should be willing to share their CGM data upon admission and discharge. Those not using a personal CGM or unable to consent to data sharing are excluded.

Inclusion Criteria

I am either male or female.

I use a continuous glucose monitor (CGM) and will bring it to the hospital.

Expected to remain in the hospital for more than 48 hours

Exclusion Criteria

I am on dialysis due to end-stage renal disease or acute kidney failure.

I use Medtronic or Dexcom sensors and take more than 4g of acetaminophen daily.

I am unable to understand and give consent for my own medical treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants are hospitalized and monitored for glucose control using CGM data, with adjustments to insulin therapy based on real-time data for the intervention arm.

Up to 8 weeks

Continuous monitoring during hospitalization

Follow-up

Participants' glucose levels and satisfaction with CGM monitoring are assessed at discharge.

At discharge

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Personal Continuous Glucose Monitor (CGM)

Trial Overview The study tests if monitoring real-time CGM data in the hospital can guide insulin therapy more effectively than standard methods, aiming to improve blood sugar control and reduce episodes of low or high blood sugar without affecting patient satisfaction.

How Is the Trial Designed?

Group I: Monitored Experimental Treatment 3 Interventions

patients admitted to the hospital wearing a CGM with data monitored in real time

Group II: Control Active Control 1 Intervention

patients admitted to the hospital wearing a CGM with data not monitored in real time

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

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

The Effectiveness of Continuous Glucose Monitoring ... In conclusion, our study demonstrates that CGM devices lead to significant improvements in glycemic control in comparison to SMBG, including ...

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

Continuous Glucose Monitoring (CGM) Real-time continuous glucose monitoring has led to tremendous outcomes for people with diabetes who, without a CGM, may have experienced potentially life- ...

3. diabetesjournals.org diabetesjournals.org/care/article/48/9/1581/163057/Real-Time-Continuous-Glucose-Monitoring-in

Real-Time Continuous Glucose Monitoring in Pregnancies ... We demonstrated a significantly higher %TIR using real-time CGM compared with CBG glucose monitoring among pregnant people with GDM. Studies are ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S016882272400809X

The effectiveness of continuous glucose monitoring with ... In participants with type 2 diabetes, trials of CGM have demonstrated an average effectiveness of 0.31 % [3.4 mmol/mol] lower HbA1c compared to CBG, across 12 ...

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

Advances in Continuous Glucose Monitoring: Clinical ... Studies show that people with diabetes (PwD) using CGM achieve better glycemic outcomes and greater satisfaction with their diabetes management.

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

Demonstrating the Clinical Impact of Continuous Glucose ... Data from this study demonstrated that a CGM device improved patient health, decreased utilization, and reduced PMPM cost in a cohort of patients with diabetes.

7. 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.

8. 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 ... Visualization of glucose data can enable providers to educate individuals to understand and avoid hypoglycemia; Potentially avoid hospitalizations via reduction ...

9. jmcp.org jmcp.org/doi/10.18553/jmcp.2024.30.10-b.s30

Using continuous glucose monitoring to measure and ... The Glucose Management Indicator can be used as a measure of glucose control. This article discusses the benefits of value-based care, the importance of ...