Accuracy and Perspectives of CGM Use During Hospitalization in Youth

Hyperglycemia Clinical Trial

Official title:

Accuracy and Perspectives of CGM Use During Hospitalization in Youth

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06143202
• Other study ID #: 23-1051
• Status: Not yet recruiting
• Start date: February 15, 2025
• Est. completion date: February 14, 2026

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: February 14, 2026
• Est. primary completion date: February 14, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperglycemia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	Stanford University, University of California, San Francisco

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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