Continuous Glucose Monitoring for Diabetes

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Under 18, Covid-19, Mental status, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Up to 30 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of continuous glucose monitors (CGMs) for hospitalized patients with diabetes who are not in the ICU. Researchers aim to determine if these monitors can accurately track blood sugar levels and help prevent extreme blood sugar episodes compared to traditional finger-prick tests. The trial tests whether alerts from these devices enable nurses to respond more quickly to changes in blood sugar. It is suitable for individuals with Type 1 or Type 2 diabetes who already use a CGM and are admitted to the hospital for medical or surgical reasons. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance hospital care for diabetes patients.

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

The trial does not specify if you need to stop your current medications. It includes patients treated with diet, insulin, or oral diabetes medications, so you may be able to continue your current treatment.

What prior data suggests that Continuous Glucose Monitors are safe for hospital use?

Research shows that continuous glucose monitors (CGMs) are generally safe for people with diabetes. These devices, worn on the body, track blood sugar levels in real-time. Studies have found that CGMs accurately measure sugar levels by checking the fluid between cells.

No major safety issues have been reported with CGMs. Most users tolerate them well and wear them continuously to manage their diabetes. Some people might experience minor skin irritation where the device attaches, but this is uncommon. The FDA has approved CGMs for managing diabetes, indicating they have passed safety checks.

Overall, CGMs are considered safe and effective for monitoring blood sugar levels. They provide important alerts for high or low glucose, helping to prevent dangerous episodes of high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia). ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Continuous Glucose Monitors (CGMs) for diabetes because they offer real-time glucose tracking, which is a game-changer compared to traditional finger-prick tests. Unlike standard methods that provide only intermittent glucose data, CGMs continuously monitor glucose levels, helping patients and healthcare providers quickly respond to high or low blood sugar levels. This immediate feedback can be crucial for patients admitted to hospitals, as it enables timely adjustments in their treatment, potentially improving outcomes and enhancing overall diabetes management.

What evidence suggests that Continuous Glucose Monitors are effective for diabetes management?

Studies have shown that continuous glucose monitors (CGMs) help manage diabetes by providing real-time blood sugar levels. Users can see if their sugar is too high or too low and take corrective action. Research indicates that using a CGM can lead to a small but important drop in HbA1c levels, a measure of long-term blood sugar control, for those with type 2 diabetes. Additionally, CGMs help prevent dangerous sugar spikes (high blood sugar) and drops (low blood sugar) by sending alerts. Overall, CGMs have proven to be an effective tool for better managing blood sugar levels. Participants in this trial will use CGMs to monitor their glucose levels in an inpatient setting, with device alarms communicated to nursing staff for timely intervention. ^{1 6 7 8 9}

Who Is on the Research Team?

Adrian Dumitrascu, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults with Type 1 or 2 Diabetes Mellitus who are hospitalized but not in the ICU. They must have their own Continuous Glucose Monitor (CGM) and be treated with diet, insulin, or oral medications. Excluded are those unable to scan CGMs every 8 hours, hospitalized under 24 hours, with COVID-19, skin infections at CGM site, altered mental status, or unable to consent.

Inclusion Criteria

Have their own Continuous Glucose Monitoring (CGM) monitor present on admission or able to be placed after admission

You have either type 1 or type 2 diabetes.

Patients admitted under medical or surgical services

Exclusion Criteria

You have an infection at the site where the sensor is placed, and it needs to be removed.

Patients who have changes in their ability to think clearly or remember things.

Inability to provide written consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Patients continue to use their home CGMs in the hospital, with data collection and comparison to POC glucometer readings

Up to 30 days

Daily monitoring (in-hospital)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including readmission rates and CGM data analysis

30 days post discharge

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Glucose Monitor (CGM)

Trial Overview The study tests if patients' own CGMs can accurately monitor blood glucose levels compared to standard point-of-care testing in a non-ICU hospital setting. It also examines whether CGM alerts can prevent extreme high and low blood sugar episodes.

How Is the Trial Designed?

Group I: CGM Patients Experimental Treatment 1 Intervention

Patients with diabetes mellitus admitted to the hospital and using a CGM will be encouraged to continue to use these devices in inpatient setting. The device alarms of high or low glucose levels will be communicated to the nursing staff.

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

Approved in United States as Continuous Glucose Monitoring System for:

• Type 1 diabetes
• Type 2 diabetes
• Glycemic control
• Hypoglycemia prevention

Approved in European Union as Continuous Glucose Monitoring System for:

• Type 1 diabetes
• Type 2 diabetes
• Glycemic control
• Hypoglycemia prevention

Approved in Canada as Continuous Glucose Monitoring System for:

• Type 1 diabetes
• Type 2 diabetes
• Glycemic control
• Hypoglycemia prevention

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

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

Effectiveness of Continuous Glucose Monitoring on Metrics ... Both rt-CGM and flash CGM led to modest but statistically significant declines in HbA1c among individuals with T2DM, with little heterogeneity in the results.

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

The Effectiveness of Continuous Glucose Monitoring ... This retrospective study aimed to assess the effectiveness of continuous glucose monitoring (CGM) devices in managing uncontrolled diabetes mellitus (DM).

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

Continuous Glucose Monitoring (CGM) With a CGM, one can see in real time if they're trending high or low and take preventative measures against hypoglycemia (low blood glucose) and hyperglycemia ( ...

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

Real-Time Continuous Glucose Monitoring in Pregnancies ... Adverse perinatal outcomes have been associated with hyperglycemia based on CGM metrics (7,15,16), but randomized controlled trials are lacking ...

5. 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4014941/

Continuous glucose monitoring system: Is it really accurate ... The continuous glucose monitoring system (CGM) has been used for constant checking of glucose level by measuring interstitial glucose concentrations.

7. 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.

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK279046/

Continuous Glucose Monitoring, Mobile Technology ... - NCBI This chapter will review the latest evidence for use of professional and personal CGM, mobile glucose monitoring approaches, and biomarkers of glycemic control.

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

Continuous Glucose Monitoring in Individuals With Type 2 ... A quality improvement (QI) program to evaluate the feasibility and impact of CGM use in its patients with type 2 diabetes.