Continuous Glucose Monitor for Mayo Clinic Advanced Care at Home Patients

Overview

About this study

A prospective randomized, pilot, unblinded, two-arm study to investigate diabetes mellitus control with the use of CGM and diabetes education compared with usual care and diabetes education in male and female patients 18 years of age or older with diabetes mellitus under treatment with insulin therapy who are actively enrolled in Mayo Clinic’s Advanced Care at Home Program. 

The purpose of this study is to determine if applying CGM technology in the ACH setting is a low-risk intervention that could have significant benefits for diabetes mellitus management including improved average glucose, early identification of hyperglycemic or hypoglycemic states, reduced capillary glucose measurements and improved patient satisfaction.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 08/21/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Adrian Dumitrascu, M.D.

Open for enrollment

Contact information:

Adrian Dumitrascu M.D.

(904) 956-0081

Dumitrascu.Adrian@mayo.edu

More information

Publications

Publications are currently not available