Feasibility of CGM Use in Hospitalized Youth
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Freestyle Libre 3 Continuous Glucose Monitor.
- Who it may be relevant to
- Registry conditions: Hyperglycemia. Basic parameters: 2 years — 26 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Feasibility of Continuous Glucose Monitor Use In Hospitalized Youth
Overview
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.
Interventions
- 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.
Primary outcome measures
- Retrospective glycemic CGM and point of care comparison [Time frame: Duration of study, approximately 1 year from study start]
Secondary outcome measures (4)
- Nursing staff perspectives of CGM use in the hospital [Time frame: Duration of study, approximately to 1 year from study start]
- Patient/Family perspectives of CGM use in the hospital [Time frame: Duration of study, approximately 1 year from study start]
- Feasibility of CGM use through assessment of discontinuation and data loss [Time frame: Duration of study, approximately 1 year from study start]
- Health economics data [Time frame: Duration of study, approximately 1 year from study start]
Eligibility criteria
Inclusion criteria
- 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).
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 3 centers
- University of California San Francisco — San Francisco
- Stanford University — Stanford
- University of Colorado, Barbara Davis Center — Aurora
Identifiers
NCT: NCT06143202 · 23-1051