Accuracy and Perspectives of CGM Use During Hospitalization in Youth

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hyperglycemia
• Intervention / Treatment: Device: Dexcom Pro CGM

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 120

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pediatric participants will be admitted to the hospital and have hyperglycemia resulting in an endocrine consult and requiring frequent glucose monitoring.

Nursing staff providing medical care for the pediatric participant will be invited to complete a survey on usability of the CGM in the hospital setting.

Description

Inclusion Criteria:

1. Participants will be 2 to less than 18 years of age at the time of enrollment.
2. 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.
3. 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.
4. 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:

1. 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).
2. 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]).
3. Admission to inpatient psychiatry.
4. Pregnancy.
5. Currently using hydroxyurea.
6. A condition that the investigator determines would prevent the patient from participation.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pediatric patients with hyperglycemia; Any pediatric patient admitted to the hospital and requiring an endocrine consult for frequent glucose monitoring and hyperglycemia management	Device: Dexcom Pro CGM; 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.
Nursing staff; Nursing staff providing medical care for pediatric patients enrolled in the study.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: University of California, San Francisco; Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): February 15, 2024
• Primary Completion (Estimated): February 14, 2025
• Study Completion (Estimated): February 14, 2025

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Pediatrics; Hospital; Hyperglycemia; Continuous glucose monitors
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia
• Other Study ID Numbers: 23-1051

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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.: Yes