A Study to Evaluate Continuous Glucose Monitor in Hospitalized, Post-operative Patients With Diabetes Mellitus

Study Overview
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Brief Summary
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The purposes of this study is to study if CGMs worn in the postoperative ICU or non-ICU hospital setting have adequate accuracy for blood glucose monitoring when compared to point-of-care (POC) capillary glucometers.

Detailed Description
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Eligible patients will be approached by research staff either preoperatively or on the first 5 days post-surgery and offered to be enrolled. If agreed to participate, they will be fitted with a blinded CGM monitor (Dexcom G6 PRO) as soon as they are awake and alert after the surgery. They will continue to have their blood glucose check as usual in the ICU and on surgical floors with POC glucometers. On discharge, or at the end of the first CGM sensor life, the sensor will be removed and sensor data will be analyzed. CGM data will be compared with Point-of-Care blood glucose monitoring obtained in the hospital.

Official Title
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Hospital Use of CGM (Continuous Glucose Monitor) in Post-operative Patients With Diabetes Mellitus at High Risk for Hypo and Hyperglycemia

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Continuous Glucose Monitor (CGM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Type 1 or 2 Diabetes Mellitus. Patients 18 years of age or older. Admitted for deceased donor renal transplant surgery, pancreas transplant surgery, heart transplant surgery, liver transplant surgery and lung transplant surgery. Anticipated minimum of 72h hospital stay. Patients on insulin therapy (IV, SQ) post-surgery. Exclusion Criteria: Active COVID-19 infection. Pregnant or lactating female. Altered Mental Status at the time of sensor placement (sensor will be placed once mental status will improve). Inability to provide informed consent. Patients taking more than 4 g of acetaminophen in 24 hours or more than 1 gm every 6 hours. Patients with skin lesions at the application site that may interfere with placement of the sensor. Patients with known allergy to medical grade adhesive.

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: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CGM Patients<br>Subjects with diabetes mellitus or medication induced diabetes that have been admitted to the hospital after a surgery for organ transplantation or scheduled for organ transplant surgery will be fitted with a CGM monitor to monitor glucose levels during hospitalization | Device: Continuous Glucose Monitor (CGM)<br>* A device that measures blood sugar levels every 1-5 minutes<br>* Other names: Dexcom G6 PRO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGM accuracy | Measured by the mean absolute relative difference (MARD), calculated between matched pairs of POC (point of care) glucose monitors and the closest CGM reading. MARD will be summarized as mean (standard deviation) or median (range) for glucose readings <70g/dl, >180g/dl, >250g/dl respectively. | From date of enrollment and until discharge from the hospital up to 30 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGM recorded hypoglycemia episodes | The incidence and duration of hypoglycemic episodes | From date of enrollment and until discharge from the hospital up to 30 days. | 
| CGM recorded hyperglycemia episodes | The incidence of hyperglycemic episodes | From date of enrollment and until discharge from the hospital up to 30 days. |