Feasibility of CGM Use in Hospitalized Youth

Официальное название

Feasibility of Continuous Glucose Monitor Use In Hospitalized Youth

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Retrospective glycemic CGM and point of care comparison [Срок оценки: Duration of study, approximately 1 year from study start]

Вторичные конечные точки (4)

• Nursing staff perspectives of CGM use in the hospital [Срок оценки: Duration of study, approximately to 1 year from study start]
• Patient/Family perspectives of CGM use in the hospital [Срок оценки: Duration of study, approximately 1 year from study start]
• Feasibility of CGM use through assessment of discontinuation and data loss [Срок оценки: Duration of study, approximately 1 year from study start]
• Health economics data [Срок оценки: Duration of study, approximately 1 year from study start]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 3 центра

• University of California San Francisco — San Francisco
• Stanford University — Stanford
• University of Colorado, Barbara Davis Center — Aurora

Идентификаторы

NCT: NCT06143202 · 23-1051

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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