Clinical trial NCT06143202: Feasibility of CGM Use in Hospitalized Youth
Official title: Feasibility of Continuous Glucose Monitor Use In Hospitalized Youth
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hyperglycemia
Keywords: Hyperglycemia
Continuous glucose monitors
Pediatrics
Hospital
Diabetes
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: Stanford University
First posted: 2023-11-22
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric 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 pediatric participant will be invited to complete a survey on usability of the CGM in the hospital setting.

Brief summary: This study is assessing the feasibility of a continuous glucose monitor during hospital admissions in youth with hyperglycemia due to diabetes or other underlying conditions that requires frequent glucose monitoring, through pediatric 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: Pediatric 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.

Eligibility criteria: Inclusion Criteria:

1. Participants will be 2 to less than 18 years of age at the time of enrollment.
2. 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.
3. 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.
4. 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:

1. 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).
2. 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 \[i.e. 24-48 before planned procedure\]).
3. Admission to inpatient psychiatry.
4. Pregnancy.
5. Currently using hydroxyurea.
6. A condition that the investigator determines would prevent the patient from participation.

Primary outcomes:
measure: Retrospective glycemic CGM and point of care comparison
timeFrame: Duration of study, approximately 1 year from study start
Secondary outcomes:
measure: Nursing staff perspectives of CGM use in the hospital
timeFrame: Duration of study, approximately to 1 year from study start
measure: Patient/Family perspectives of CGM use in the hospital
timeFrame: Duration of study, approximately 1 year from study start
measure: Feasibility of CGM use through assessment of discontinuation and data loss
timeFrame: Duration of study, approximately 1 year from study start
measure: Health economics data
timeFrame: Duration of study, approximately 1 year from study start
Other outcomes:
Locations:
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