Print

Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Continuous Glucose Monitoring 		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.
  • Device: Continuous 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.
No Intervention
Control Arm (Standard of Care) 		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.

Recruiting Locations

Mayo Clinic in Florida
Jacksonville, Florida 32224
Contact:
Adrian Dumitrascu, MD
904-953-2000
Dumitrascu.Adrian@mayo.edu

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.