Freestyle Libre 3 Continuous Glucose Monitor
DeviceYouth 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.
NCT Number: NCT06143202
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.
Interested in participating?
Request Info2 year–26 year
All sexes
Observational
University of California San Francisco, San Francisco, California, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Duration of study, approximately 1 year from study start
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.
Time frame: Duration of study, approximately to 1 year from study start
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
Time frame: Duration of study, approximately 1 year from study start
Surveys will be completed by patients/family to evaluate their experience with sensor wear in the hospital, sensor insertion, and goals for glycemic monitoring while in the hospital.
Time frame: Duration of study, approximately 1 year from study start
Identify the frequency and causes of sensor discontinuation as well as information on sensor data loss.
Time frame: Duration of study, approximately 1 year from study start
Pilot analysis of health economics data from costs related to glycemic monitoring during the hospitalization.
University of Colorado, Denver
Other
Feasibility of Continuous Glucose Monitor Use In Hospitalized Youth
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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