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NCT05902104 · ClinicalTrials.gov registry record
CGM-Assisted Management of PN
A clinical trial of Hypoglycemia and Hyperglycemia, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- 10
- Enrollment target
- 1
- Study location
NCT05902104: Recruiting study of Hypoglycemia and Hyperglycemia, sponsored by Boston Children's Hospital.
NCT05902104 is a study of Hypoglycemia and Hyperglycemia that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 10 participants, below the 506-participant average among 40 other Hypoglycemia trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05902104, a study of Hypoglycemia and Hyperglycemia, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- 10 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Study Locations (1)
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-07-06 |
| Est. Completion | 2025-08 |
What NCT05902104 shows while recruiting
NCT05902104 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 506-participant average among 40 other Hypoglycemia trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Hypoglycemia appearing as the primary indexed condition, and to 0 interventions.
NCT05902104 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05902104 about?
NCT05902104 is a clinical study titled "CGM-Assisted Management of PN". 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 d...
What is the current status of trial NCT05902104?
This trial is currently recruiting. The enrollment target is 10 participants. The study started on 2023-07-06. Estimated completion is 2025-08.
What conditions does trial NCT05902104 study?
This clinical trial studies the following conditions: Hypoglycemia, Hyperglycemia, Intestinal Failure.
Who is sponsoring clinical trial NCT05902104?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05902104 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05902104's enrollment target sits among peer trials
10 33rd of 40 higher than 5 of 40 other Hypoglycemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypoglycemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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