Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring System in Non-Critically Ill Patients in the Inpatient Setting

Study Overview
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Brief Summary
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Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring System in Non-Critically Ill Patients in the Inpatient Setting

Detailed Description
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To assess the performance of the CGM System in comparison to a blood glucose comparator method in non-critically ill hospitalized patients who need glucose control.

Official Title
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Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring System in Non-Critically Ill Patients in the Inpatient Setting

Conditions
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Patients Needing Glucose Control

Intervention / Treatment
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* Device: Continuous Glucose Monitoring System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age and older Admitted to the hospital in a non-ICU bed or once transferred out of ICU Anticipate at least 48 hours of hospital stay On treatment for glucose control. Willingness to complete the study. Willingness to wear up to 3 CGM systems simultaneously. Two in the abdomen and one on the back of the arm or one on each arm and one on the abdomen. Subject and/or caretaker are able to speak, read, and write English Exclusion Criteria: Presence of extensive skin changes/diseases at sensor wear site(s) that preclude wearing the sensor(s) on normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) Currently in an intensive care unit (ICU) of the following type (does not apply to participants placed in an ICU bed due to space issues in the non-ICU areas) Known allergy to medical-grade adhesives Pregnancy, demonstrated by a positive test (for subjects of childbearing potential) Women admitted to give birth or any other admission related to pregnancy Patients receiving Hydroxyurea Bleeding disorder Participants that are currently being treated for malignancies, cancer Participant that are hospitalized to receive an organ transplant Require a Magnetic Resonance Imaging (MRI) scan End stage renal disease and currently managed by dialysis or anticipating initiating dialysis during the study wear period Current participation in another investigational study protocol (If a subject has recently completed participation in another drug study, the subject must have completed that study at least 7 days prior to being enrolled in this study.) Any condition that, in the opinion of the Investigator, would interfere with their participation in the trial or pose an excessive risk to study staff (e.g., known history of hepatitis B or C)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hospitalized Patients<br>To assess performance of CGM compared to comparator measurement. | Device: Continuous Glucose Monitoring System<br>* Continuous Glucose Monitoring System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System Performance | Assess the performance of the CGM System in comparison to a blood glucose comparator method in non-critically ill hospitalized patients who need glucose control. | Up to 10 days |