RecruitingNot ApplicableNCT05880810

Continuous Glucose Monitor for Mayo Clinic Advanced Care at Home Patients

Continuous Glucose Monitor Use for Mayo Clinic Advanced Care at Home Patients With Diabetes Mellitus


Sponsor

Mayo Clinic

Enrollment

100 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria19

  • 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.

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Interventions

DEVICEContinuous Glucose Monitor Dexcom G6 PRO

Connected to a smart phone that transmits continuous glucose monitoring data in real time to Advanced Care at Home Command Center for monitoring.


Locations(1)

Mayo Clinic in Florida

Jacksonville, Florida, United States

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NCT05880810


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