Continuous Glucose Monitor for Mayo Clinic Advanced Care at Home Patients

NCT ID: NCT05880810

Last Updated: 2025-06-04

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2027-05-31

Brief Summary

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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).

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Continuous Glucose Monitor Dexcom G6 PRO

Intervention Type DEVICE

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.

Group Type NO_INTERVENTION

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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Adrian G. Dumitrascu

Principal Investigator

Responsibility Role 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

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Adrian Dumitrascu, MD

Role: primary

904-953-2000

Other Identifiers

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23-000733

Identifier Type: -

Identifier Source: org_study_id

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