Trials / Enrolling By Invitation
Enrolling By InvitationNCT06143202
Feasibility of CGM Use in Hospitalized Youth
Feasibility of Continuous Glucose Monitor Use In Hospitalized Youth
- Status
- Enrolling By Invitation
- Phase
- —
- Study type
- Observational
- Enrollment
- 120 (estimated)
- Sponsor
- University of Colorado, Denver · Academic / Other
- Sex
- All
- Age
- 2 Years – 26 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Youth and young adult 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 28 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Freestyle Libre 3 Continuous Glucose Monitor | 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. |
Timeline
- Start date
- 2025-07-15
- Primary completion
- 2027-02-14
- Completion
- 2027-02-14
- First posted
- 2023-11-22
- Last updated
- 2026-03-03
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06143202. Inclusion in this directory is not an endorsement.