CGM-Assisted Management of PN

NCT05902104 | Completed

• 1 other identifier: IRB-P00039631
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn more about changes in glucose levels in hospitalized infants with intestinal failure receiving parenteral nutrition or PN (nutrients delivered intravenously), as they transition from continuous PN (given 24 hours a day) to cycled PN (given less than 24 hours a day). There is an increased risk of glucose abnormalities with cycled PN, which can be harmful to infant growth and brain health. Continuous glucose monitors (CGM) will be used to measure interstitial glucose levels (in the tissue under the skin), which are similar to blood glucose levels. CGM is a small, minimally-invasive sensor worn on the thigh, which gives a glucose measurement every 5 minutes, and can help us understand changes in blood sugar levels without having to do a blood draw or fingerstick. CGM will be used during PN cycling for up to 30 days or until hospital discharge. If target GIR cycled PN is not reached following 3 sensor periods (up to 10 days per sensor), the parent/guardian will be approached to accept or decline participation in an optional extension phase. In the extension phase, the primary study will be repeated and CGM monitoring will continue until target GIR cycled PN is reached, up to an additional 3 sensor placements. CGM data will be hidden from the clinical team, there will be no change to routine clinical care. CGM may provide false low glucose readings when the tissue around the sensor is compressed (compression lows), such as when laying on the sensor during sleep. We will generate data during the study to help identify and filter the final dataset to remove likely compression lows. This study may help us understand how cycled PN affects glucose levels in infants with intestinal failure, which may help other children treated with cycled PN in the future.

Conditions

Intestinal Failure; Hypoglycemia; Hyperglycemia

Keywords

Intestinal Failure; Parenteral Nutrition; Continuous Glucose Monitoring; Hypoglycemia; Hyperglycemia

Outcome Measures

Primary Outcomes (2)

• Trough glucose while PN is suspended

  For each subject, "trough glucose" will be defined as the lowest sensor glucose value, during the entire study period, that occurs while PN is suspended.

  Through study completion, up to 30 days

• Average glucose while receiving the target GIR

  For each subject, "average glucose" will be defined as an average of all sensor glucose values recorded while receiving the target GIR. "Target GIR" will be defined as the final GIR prior to discharge home, or highest GIR given during the study period if clinical goal GIR is not reached during the study period.

  Through study completion, up to 30 days

Secondary Outcomes (1)

• Measures of dysglycemia

  Through study completion, up to 30 days

Eligibility Criteria

• Age: 2 Months - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Inpatients at Boston Children's Hospital (BCH) with intestinal failure dependent on PN followed by the Home Parenteral Nutrition (HPN) and/or Center for Advanced Intestinal Rehabilitation (CAIR) program at BCH.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• DexCom, Inc.: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (4)

• Bendorf K, Friesen CA, Roberts CC. Glucose response to discontinuation of parenteral nutrition in patients less than 3 years of age. JPEN J Parenter Enteral Nutr. 1996 Mar-Apr;20(2):120-2. doi: 10.1177/0148607196020002120.

  PMID: 8676529 BACKGROUND

• Beltrand J, Colomb V, Marinier E, Daubrosse C, Alison M, Burcelin R, Cani PD, Chevenne D, Marchal CL. Lower insulin secretory response to glucose induced by artificial nutrition in children: prolonged and total parenteral nutrition. Pediatr Res. 2007 Nov;62(5):624-9. doi: 10.1203/PDR.0b013e3181559d5c.

  PMID: 17805200 BACKGROUND

• Austhof SI, DeChicco R, Cresci G, Corrigan ML, Lopez R, Steiger E, Kirby DF. Expediting Transition to Home Parenteral Nutrition With Fast-Track Cycling. JPEN J Parenter Enteral Nutr. 2017 Mar;41(3):446-454. doi: 10.1177/0148607115595620. Epub 2016 Sep 29.

  PMID: 26187939 BACKGROUND

• Yanagisawa R, Takeuchi K, Komori K, Fujihara I, Hidaka Y, Morita D, Futatsugi A, Ono T, Hidaka E, Sakashita K, Shiohara M. Hypoglycemia During the Temporary Interruption of Parenteral Nutrition Infusion in Pediatric Hematopoietic Stem Cell Transplantation. JPEN J Parenter Enteral Nutr. 2017 Nov;41(8):1414-1418. doi: 10.1177/0148607116665797. Epub 2016 Aug 23.

  PMID: 27554675 BACKGROUND

MeSH Terms

Conditions

Intestinal Failure; Hypoglycemia; Hyperglycemia; Hyperphagia

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael SD Agus, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chief, Medical Critical Care

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 13, 2023
• Study Start: July 6, 2023
• Primary Completion: May 16, 2025
• Study Completion: May 16, 2025
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)