Continuous Glucose Monitor for Mayo Clinic Advanced Care at Home Patients

Study Overview
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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).

Official Title
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Continuous Glucose Monitor Use for Mayo Clinic Advanced Care at Home Patients With Diabetes Mellitus

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Continuous Glucose Monitor Dexcom G6 PRO


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Glucose Monitoring<br>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. | Device: Continuous Glucose Monitor Dexcom G6 PRO<br>* Connected to a smart phone that transmits continuous glucose monitoring data in real time to Advanced Care at Home Command Center for monitoring.<br>|
| No Intervention: Control Arm (Standard of Care)<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in Range | Percentage of time with continuous glucose monitor values within 70-180 mg/dl | 10 days | 
| Mean daily glucose | Mean daily glucose level (mg/dl) | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 10 days | 
| Mean absolute relative difference (MARD) variation with Oxygen saturation. | Measured in percentage | 10 days | 
| Mean absolute relative difference (MARD) variation with Daily hemoglobin. | Measured in grams per deciliter (g/dl) | 10 days | 
| Mean absolute relative difference (MARD) variation with Glomerular filtration rate (GFR) | Measured in ml/min | 10 days | 
| Mean absolute relative difference (MARD) variation with Arterial blood pressure | Measured in millimeters of mercury (mmHg) | 10 days | 
| Percentage of subjects to continue use of continuous glucose monitor | Percentage of subjects will using continuous glucose monitor at 40 days post enrollment | 40 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Care at Home Program (home hospital)