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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
| Stanford University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Nursing staff | Nursing staff providing medical care for youth and young adult patients enrolled in the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Freestyle Libre 3 Continuous Glucose Monitor | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Retrospective glycemic CGM and point of care comparison | 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. | Duration of study, approximately 1 year from study start |
| Measure | Description | Time Frame |
|---|---|---|
| Nursing staff perspectives of CGM use in the hospital | 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 | Duration of study, approximately to 1 year from study start |
| Patient/Family perspectives of CGM use in the hospital |
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Inclusion Criteria:
Exclusion Criteria:
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Youth and young adult participants will be admitted to the hospital and have hyperglycemia resulting in an endocrine consult and requiring frequent glucose monitoring.
Nursing staff providing medical care for the youth and young adult participant will be invited to complete a survey on usability of the CGM in the hospital setting.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94158 | United States | ||
| Stanford University |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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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. |
| Duration of study, approximately 1 year from study start |
| Feasibility of CGM use through assessment of discontinuation and data loss | Identify the frequency and causes of sensor discontinuation as well as information on sensor data loss. | Duration of study, approximately 1 year from study start |
| Health economics data | Pilot analysis of health economics data from costs related to glycemic monitoring during the hospitalization. | Duration of study, approximately 1 year from study start |
| Stanford |
| California |
| 94305 |
| United States |
| University of Colorado, Barbara Davis Center | Aurora | Colorado | 80045 | United States |