Feasibility of CGM Use in Hospitalized Youth

NCT06143202 | Enrolling By Invitation FDA Device

• 1 other identifier: 23-1051
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

This study is assessing the feasibility of a continuous glucose monitor during hospital admissions in youth and young adults with hyperglycemia due to diabetes or other underlying conditions that requires frequent glucose monitoring, through patient/family and nursing staff feedback on their perspectives and usability of the system in the hospital will be assessed through surveys. In addition, retrospective glycemic comparisons between CGM data and POC will be conducted.

Conditions

Hyperglycemia

Keywords

Hyperglycemia; Continuous glucose monitors; Pediatrics; Hospital; Diabetes

Outcome Measures

Primary Outcomes (1)

• Retrospective glycemic CGM and point of care comparison

  Glycemic data related to time in range, time hypoglycemic, time hyperglycemic and the time of first onset of hypoglycemia and hyperglycemia will be obtained by both CGM and point of care glucose values.

  Duration of study, approximately 1 year from study start

Secondary Outcomes (4)

• Nursing staff perspectives of CGM use in the hospital

  Duration of study, approximately to 1 year from study start

• Patient/Family perspectives of CGM use in the hospital

  Duration of study, approximately 1 year from study start

• Feasibility of CGM use through assessment of discontinuation and data loss

  Duration of study, approximately 1 year from study start

• Health economics data

  Duration of study, approximately 1 year from study start

Study Arms (2)

You and young adult patients with hyperglycemia

Any youth and young adult patient admitted to the hospital and requiring an endocrine consult for frequent glucose monitoring and hyperglycemia management

Device: Freestyle Libre 3 Continuous Glucose Monitor

Nursing staff

Nursing staff providing medical care for youth and young adult patients enrolled in the study.

Interventions

Freestyle Libre 3 Continuous Glucose Monitor DEVICE

Youth and young adult participants will wear a blinded Freestyle Libre 3 CGM. Data will not be available, and therefore the device will not be used to modify medical management.

You and young adult patients with hyperglycemia

Eligibility Criteria

• Age: 2 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Youth and young adult 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 youth and young adult participant will be invited to complete a survey on usability of the CGM in the hospital setting.

You may qualify if:

• Participants will be 2 to less than 26 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• University of California, San Francisco: collaborator
• Stanford University: collaborator

Study Sites (3)

University of California San Francisco

San Francisco, California, 94158, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

University of Colorado, Barbara Davis Center

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Hyperglycemia; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 22, 2023
• Study Start: July 15, 2025
• Primary Completion (Estimated): February 14, 2027
• Study Completion (Estimated): February 14, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)