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

142 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to determine if patient's own Continuous Glucose Monitor (CGMs) worn in the non-ICU hospital setting have adequate accuracy for blood glucose monitoring when compared to point-of-care (POC) capillary glucose measurement, and to determine if alerts given by CGMs worn in the non-ICU hospital would prevent episodes of hyperglycemia and hypoglycemia.

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+