Clinical trial NCT05880810: Continuous Glucose Monitor for Mayo Clinic Advanced Care at Home Patients
Official title: Continuous Glucose Monitor Use for Mayo Clinic Advanced Care at Home Patients With Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Advanced Care at Home Program (home hospital)
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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.

Primary outcomes:
measure: Time in Range
timeFrame: 10 days
measure: Mean daily glucose
timeFrame: 10 days
Secondary outcomes:
measure: Frequency of hypoglycemia episodes
timeFrame: 10 days
measure: Mean absolute relative difference (MARD) variation with Oxygen saturation.
timeFrame: 10 days
measure: Mean absolute relative difference (MARD) variation with Daily hemoglobin.
timeFrame: 10 days
measure: Mean absolute relative difference (MARD) variation with Glomerular filtration rate (GFR)
timeFrame: 10 days
measure: Mean absolute relative difference (MARD) variation with Arterial blood pressure
timeFrame: 10 days
measure: Percentage of subjects to continue use of continuous glucose monitor
timeFrame: 40 days
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Adrian Dumitrascu, MD
role: PRINCIPAL_INVESTIGATOR
References: