Status:
NOT_YET_RECRUITING
Feasibility of CGM Use in Hospitalized Youth
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
University of California, San Francisco
Stanford University
Conditions:
Hyperglycemia
Eligibility:
All Genders
2-17 years
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 glu...
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,...
Eligibility Criteria
Inclusion
- Participants will be 2 to less than 18 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).
Exclusion
- 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.
Key Trial Info
Start Date :
February 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 14 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06143202
Start Date
February 15 2025
End Date
February 14 2026
Last Update
August 19 2024
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