Continuous Glucose Monitor for Mayo Clinic Advanced Care at Home Patients

Mayo Clinic

Status: Enrolling

Conditions: Diabetes Mellitus

Treatments: Device: Continuous Glucose Monitor Dexcom G6 PRO

Study type: Interventional

Funder types: Other

Identifiers

NCT05880810

23-000733

Details and patient eligibility

About

The purpose of this study is to measure differences in diabetes control with the use of continuous glucose monitor (CGM) and diabetes education compared with standard of care for glucose monitoring (glucometer checks) and diabetes education in participants with diabetes mellitus receiving therapy with insulin and being admitted to Mayo Clinic Advanced Care at Home Program (ACH).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who are admitted to Advanced Care at Home (ACH) Program and supposed to remain in ACH for at least 72 hours.
• Patients with previous diagnosis of DM type 1 or type 2.
• Patients taking subcutaneous (SQ) insulin either via multidose injections or SQ insulin pump.
• Capable of giving signed informed consent

Exclusion criteria

• Actively treated for diabetes ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS).
• Participants taking acetaminophen more than 4g per day or more than 1gm every 6 hours.
• Participants with altered mental status.
• Participants diagnosed with dementia.
• Patients with suicidal ideations or experiencing suicidal behavior.
• Patients with liver cirrhosis.
• Patients with End Stage Renal Disease on dialysis bot hemodialysis or peritoneal dialysis.
• Participants with allergy to medical grade adhesive or medical tape.
• Participants taking hydroxyurea.
• Participants who are pregnant, wanting to become pregnant, or nursing during study period.
• Patients with a planned MRI within the following 10 days after admission to ACH.
• Participants currently using continuous glucose monitor (CGM) to dose insulin or check glucose level.
• Participants with diabetes mellitus (DM) treated with diet alone.
• Participants with DM treated with oral hypoglycemic medications.
• Participants with DM treated with one SQ insulin injection daily.
• Participants enrolled in other studies addressing CGM use.
• Participants physically or emotionally incapable of handling a cell phone with a smart display.
• Participants with hearing impaired to a degree that they are not able to hear a smart phone alert or alarm.
• Patients lacking WIFI or Cellular coverage needed to connect the monitoring cell phone to Internet network.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Continuous Glucose Monitoring

Experimental group

Description:

Subjects admitted to the Advanced Care at Home program (home hospital) will have the continuous glucose monitor sensor placed for up to 10 days to monitor and dose insulin.

Treatment:

Device: Continuous Glucose Monitor Dexcom G6 PRO

Control Arm (Standard of Care)

No Intervention group

Description:

Subjects admitted to the Advanced Care at Home program (home hospital) will continue with standard of care glucose monitoring (capillary glucose levels checked via glucometer), insulin dosing, and DM treatment during the 10 day period.