CGM-Assisted Management of PN

Launched by BOSTON CHILDREN'S HOSPITAL · Jun 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how different ways of giving nutrients through a vein (known as parenteral nutrition or PN) affect blood sugar levels in hospitalized infants who have intestinal failure. The researchers want to see how switching from continuous PN (given all day and night) to cycled PN (given for less than 24 hours) impacts glucose levels, which can sometimes be too high or too low. To help monitor these changes, a small sensor called a continuous glucose monitor (CGM) will be placed on the child's thigh. This device measures glucose levels every 5 minutes without needing to take blood samples. The study aims to better understand how these changes in nutrient delivery might affect the growth and health of infants.

To be eligible for this study, infants must be between 60 days and 18 months old, weigh at least 4 kg, and be receiving PN at Boston Children's Hospital. They should also be ready to start transitioning to cycled PN within a month. If parents agree to participate, their child will wear the CGM for up to 30 days or until they leave the hospital, and they can also choose to continue monitoring if certain glucose targets are not met. Importantly, the information from the CGM will not be shared with the clinical team, ensuring that the child continues to receive their usual care during the trial. This research could help improve how infants with intestinal failure are treated in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of intestinal failure with PN dependence
• • Hospitalized at Boston Children's Hospital
• • Age: 60 days to 18 months
• • Corrected gestational age: greater than or equal to 40 weeks
• • Weight: greater than or equal to 4kg
• • Likely to proceed to PN cycling within the next month, as assessed by the clinical team
• Exclusion Criteria:
• • Underlying medical conditions or medications that predispose to hypoglycemia or hyperglycemia (e.g. insulin administration, systemic glucocorticoids, hyperinsulinism, adrenal insufficiency, other metabolic diseases)
• • Diffuse skin disease such that placement of a CGM sensor would be unsafe or difficult to secure
• • Known history of allergy or severe reaction to the adhesive/tape that is used to secure the CGM
• • Diffuse body edema that would limit accuracy of CGM sensor
• • Poor peripheral perfusion or use of vasoactive agents that would limit accuracy of CGM sensor
• • Use of medications that interfere with CGM accuracy (e.g. Hydroxyurea, acetaminophen at more than a maximum dose of 1 g every 6 hours up to 4 g every 24 hours)
• • Enrolled in competing clinical trial
• • Ward of the state