Feasibility of Continuous Glucose Monitor Use In Hospitalized Youth
概览
- 阶段
- 不适用
- 干预措施
- Nursing staff
- 疾病 / 适应症
- Hyperglycemia
- 发起方
- University of Colorado, Denver
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Retrospective glycemic CGM and point of care comparison
- 状态
- Enrolling By Invitation
- 最后更新
- 2个月前
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •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).
排除标准
- •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.
- •Currently using hydroxyurea.
- •A condition that the investigator determines would prevent the patient from participation.
研究组 & 干预措施
Nursing staff
Nursing staff providing medical care for youth and young adult patients enrolled in the study.
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
干预措施: Freestyle Libre 3 Continuous Glucose Monitor
结局指标
主要结局
Retrospective glycemic CGM and point of care comparison
时间窗: 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.
次要结局
- Feasibility of CGM use through assessment of discontinuation and data loss(Duration of study, approximately 1 year from study start)
- Nursing staff perspectives of CGM use in the hospital(Duration of study, approximately to 1 year from study start)
- Health economics data(Duration of study, approximately 1 year from study start)
- Patient/Family perspectives of CGM use in the hospital(Duration of study, approximately 1 year from study start)