Monitoring glucose levels in infants with intestinal failure on parenteral nutrition
CAMP: CGM-Assisted Management of PN
This study is testing how glucose levels change in hospitalized infants with intestinal failure who are switching from continuous feeding to a different feeding method to see if it helps catch any problems with their blood sugar.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 2 Months to 18 Months |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05902104 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate glucose level changes in hospitalized infants with intestinal failure who are transitioning from continuous parenteral nutrition (PN) to cycled PN. Continuous glucose monitors (CGM) will be utilized to track interstitial glucose levels every five minutes, providing insights into glucose abnormalities that may arise during this transition. The study will focus on quantifying dysglycemia associated with higher glucose infusion rates (GIR) in this vulnerable population. By using CGM, the study seeks to identify clinically actionable trends in glucose levels that may not be detected through traditional blood glucose checks.
Who should consider this trial
Good fit: Ideal candidates for this study are hospitalized infants aged 60 days to 18 months with a diagnosis of intestinal failure and dependence on parenteral nutrition.
Not a fit: Patients with underlying medical conditions or medications that predispose them to abnormal glucose levels may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of glucose levels in infants with intestinal failure, potentially enhancing their growth and brain health.
How similar studies have performed: While the use of continuous glucose monitors in infants is gaining traction, this specific approach to monitor glucose levels during the transition to cycled PN is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Michael SD Agus, MD — Boston Children's Hospital
- Study coordinator: Jessica L Ruiz, MD
- Email: jessica.ruiz@childrens.harvard.edu
- Phone: 617-355-7241
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.