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Continuous Glucose Monitor for Mayo Clinic Advanced Care at Home Patients

Primary Purpose

Diabetes Mellitus

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous Glucose Monitor Dexcom G6 PRO
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Advanced Care at Home Program (home hospital)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic in Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Continuous Glucose Monitoring

Control Arm (Standard of Care)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Time in Range
Percentage of time with continuous glucose monitor values within 70-180 mg/dl
Mean daily glucose
Mean daily glucose level (mg/dl)

Secondary Outcome Measures

Frequency of hypoglycemia episodes
Number of episodes with blood glucose below 70 mg/dl measured via point of care testing (POCT) and Continuous Glucose Monitor (CGM)
Mean absolute relative difference (MARD) variation with Oxygen saturation.
Measured in percentage
Mean absolute relative difference (MARD) variation with Daily hemoglobin.
Measured in grams per deciliter (g/dl)
Mean absolute relative difference (MARD) variation with Glomerular filtration rate (GFR)
Measured in ml/min
Mean absolute relative difference (MARD) variation with Arterial blood pressure
Measured in millimeters of mercury (mmHg)
Percentage of subjects to continue use of continuous glucose monitor
Percentage of subjects will using continuous glucose monitor at 40 days post enrollment

Full Information

First Posted
May 16, 2023
Last Updated
August 3, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05880810
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
Keywords
Advanced Care at Home Program (home hospital)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Continuous Glucose Monitoring
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Arm (Standard of Care)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Continuous Glucose Monitor Dexcom G6 PRO
Intervention Description
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 Information:
Title
Time in Range
Description
Percentage of time with continuous glucose monitor values within 70-180 mg/dl
Time Frame
10 days
Title
Mean daily glucose
Description
Mean daily glucose level (mg/dl)
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Frequency of hypoglycemia episodes
Description
Number of episodes with blood glucose below 70 mg/dl measured via point of care testing (POCT) and Continuous Glucose Monitor (CGM)
Time Frame
10 days
Title
Mean absolute relative difference (MARD) variation with Oxygen saturation.
Description
Measured in percentage
Time Frame
10 days
Title
Mean absolute relative difference (MARD) variation with Daily hemoglobin.
Description
Measured in grams per deciliter (g/dl)
Time Frame
10 days
Title
Mean absolute relative difference (MARD) variation with Glomerular filtration rate (GFR)
Description
Measured in ml/min
Time Frame
10 days
Title
Mean absolute relative difference (MARD) variation with Arterial blood pressure
Description
Measured in millimeters of mercury (mmHg)
Time Frame
10 days
Title
Percentage of subjects to continue use of continuous glucose monitor
Description
Percentage of subjects will using continuous glucose monitor at 40 days post enrollment
Time Frame
40 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Dumitrascu, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Continuous Glucose Monitor for Mayo Clinic Advanced Care at Home Patients

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