Continuous Glucose Monitor for Mayo Clinic Advanced Care at Home Patients
NCT ID: NCT05880810
Last Updated: 2025-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-05-01
2027-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Adrian G. Dumitrascu
Principal Investigator
Principal Investigators
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Adrian Dumitrascu, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Florida
Jacksonville, Florida, United States
Countries
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Facility Contacts
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Other Identifiers
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23-000733
Identifier Type: -
Identifier Source: org_study_id
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