Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT05880810

Conditions

Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Continuous Glucose Monitor Dexcom G6 PRO

Study Details

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).

Conditions

Diabetes Mellitus

Study ID

NCT05880810

Start date

May 1, 2024

Status verified date

Jun, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Time in Range [ Time Frame: 10 days ]
  • Mean daily glucose [ Time Frame: 10 days ]

Central Contacts and Locations

Locations

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Adrian Dumitrascu, MD

904-953-2000Dumitrascu.Adrian@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Keywords

  • Advanced Care at Home Program (home hospital)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-03.