Accuracy and Perspectives of CGM Use During Hospitalization in Youth

Study Overview
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Brief Summary
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This study is assessing the accuracy and usability of a continuous glucose monitor during hospital admissions in youth with hyperglycemia due to diabetes or other underlying conditions that requires frequent glucose monitoring. In addition, pediatric patient/family and nursing staff feedback on their perspectives and usability of the system in the hospital will be assessed through surveys.

Detailed Description
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Pediatric patients admitted to the hospital for any reason, but require glucose monitoring during the hospitalization will be enrolled in this study. Participant diagnosis can include type 1 diabetes, type 2 diabetes, medication-induced diabetes, cystic fibrosis-related diabetes, or other causes of hyperglycemia that it has been determined by the hospital team requires frequent glucose monitoring, with or without insulin management. Enrolled participants will wear a blinded continuous glucose monitor for up to 20 days (2 sensors) or until the end of their hospitalization. In addition, enrolled participants will complete a survey to assess their perspectives on the CGM wear experience and interest in future CGM use during hospitalizations. Nursing staff of the enrolled participant will also be invited to complete a survey regarding their perspectives of CGM use in the hospital setting.

Official Title
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Accuracy and Perspectives of CGM Use During Hospitalization in Youth

Conditions
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Hyperglycemia

Intervention / Treatment
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* Device: Dexcom Pro CGM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants will be 2 to less than 18 years of age at the time of enrollment. Participants will have a diagnosis of type 1 diabetes, type 2 diabetes, diabetes/hyperglycemia due to an underlying condition (such as in cystic fibrosis, monogenic diabetes), or medication induced diabetes/hyperglycemia (such as steroid-induced hyperglycemia or PEG-asparaginase induced hyperglycemia) and would benefit clinically from close glucose monitoring during hospitalization due to fluctuations in blood glucose values. Participant is expected to be in the hospital for longer than 12 hours after study enrollment with a goal of 36 hours or more as determined by study investigator or trained staff. Participant is willing to wear the continuous glucose monitor for the duration of the hospital admission or the lifespan of a continuous glucose monitor (7-14 days). Exclusion Criteria: Has had a history of a significant skin reaction to the adhesives of a continuous glucose monitor in the past or concerns that one may occur due to underlying skin conditions (ie severe eczema, uncontrolled psoriasis, etc). Planned MRI or surgery during the study device use (can be enrolled pre or post procedure if sufficient time for sensor wear as determined by investigator [i.e. 24-48 before planned procedure]). Admission to inpatient psychiatry. Pregnancy. Currently using hydroxyurea. A condition that the investigator determines would prevent the patient from participation.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pediatric patients with hyperglycemia<br>Any pediatric patient admitted to the hospital and requiring an endocrine consult for frequent glucose monitoring and hyperglycemia management | Device: Dexcom Pro CGM<br>* Pediatric participants will wear a blinded Dexcom Pro CGM. Data will not be available, and therefore the device will not be used to modify medical management.<br>|
| Nursing staff<br>Nursing staff providing medical care for pediatric patients enrolled in the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of the continuous glucose monitor using mean absolute relative difference (MARD). | Accuracy will be assessed using standard methods, including mean absolute relative difference (MARD). | Duration of study, approximately 1 year from study start | 
| Accuracy of the continuous glucose monitor using Clarke Error Grids | Accuracy will be assessed using standard methods, including Clarke Error Grids. | Duration of study, approximately to 1 year from study start | 
| Accuracy of the continuous glucose monitor using the % within 15/15, 20/20, and 30/30. | Accuracy will be assessed using standard methods, including the % within 15/15, 20/20, and 30/30. | Duration of study, approximately to 1 year from study start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient perspectives of CGM use in the hospital | Surveys will be provided to the patient/family to obtain qualitative perspectives on the usability of CGMs in the hospital setting | Duration of study, approximately to 1 year from study start | 
| Nursing staff perspectives of CGM use in the hospital | Surveys will be provided to the nursing staff associated with an enrolled patient participant to obtain qualitative perspectives on the usability of CGMs in the hospital setting | Duration of study, approximately to 1 year from study start | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatrics, Hyperglycemia, Continuous glucose monitors, Hospital