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NCT05857007 · ClinicalTrials.gov registry record

CGM Utilization With IV Insulin EndoTool and Subcutaneous Insulin in the Neuro ICU

A clinical trial, sponsored by Wake Forest University Health Sciences.

Completed
Registry status
8
Enrollment target

NCT05857007: Completed study, sponsored by Wake Forest University Health Sciences.

NCT05857007 is a clinical trial that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 8 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05857007 has completed, sponsored by Wake Forest University Health Sciences.

COMPLETED
Registry status
8 participants
Enrollment target

Study Summary

The goal of this study (CGM utilization with IV Insulin EndoTool and Subcutaneous Insulin in the Neuro ICU) is to understand how CGM technology utilized in conjunction with EndoTool IV insulin could improve glycemic management in the NeuroICU, specifically in predicting and preventing hypoglycemic and hyperglycemic episodes with resultant improvement in patient morbidity and mortality. The second arm of the study will focus on how CGM technology utilized in patients on basal bolus subcutaneous insulin while on high dose glucocorticoids could impact glycemic management. The main questions it aims to answer are: 1. Is CGM technology data accurate compared to the current standard point of care among NeuroICU patients? 2. How CGM technology could improve glycemic management in the critical care setting, specifically in predicting and preventing hypoglycemic episodes with IV or subcutaneous insulin? 3. How CGM technology could help treating hyperglycemia in the NeuroICU with resultant improvement in patient morbidity, mortality, and length of stay?

Primary Outcome

Neuro ICU patients with hyperglycemia, DKA or HHS and require IV insulin using the EndoTool software, will wear the freestyle Libre 2.0 CGM for either 14 consecutive days or their Neuro ICU admission. CGM data will be available in real time to monitor glucose during their hospitalization and studying if this data could improve insulin titration using the EndoTool software. Dosing of insulin will be performed utilizing standard of care fingerstick blood glucose values and not CGM data.

Interventions

  • DEVICE Libre 2.0 CGM in patients taking subcutaneous insulin with concomitant high dose glucocorticoids

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2023-07-19
Est. Completion 2023-12-31
Wake Forest University Health Sciences

1,140 total trials

What the finished NCT05857007 record still lists

NCT05857007 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 8 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Libre 2.0 CGM in patients taking subcutaneous insulin with concomitant high dose glucocorticoids is the first listed.

NCT05857007 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05857007 about?

NCT05857007 is a clinical study titled "CGM Utilization With IV Insulin EndoTool and Subcutaneous Insulin in the Neuro ICU". The goal of this study (CGM utilization with IV Insulin EndoTool and Subcutaneous Insulin in the Neuro ICU) is to understand how CGM technology utilized in conjunction with EndoTool IV insulin could improve glycemic management in the NeuroICU, specifically in predicting and preventing hypoglycemic a...

What is the current status of trial NCT05857007?

This trial is currently completed. The enrollment target is 8 participants. The study started on 2023-07-19. Estimated completion is 2023-12-31.

What interventions are being tested in trial NCT05857007?

The interventions under investigation include: Libre 2.0 CGM in patients taking subcutaneous insulin with concomitant high dose glucocorticoids (DEVICE).

Who is sponsoring clinical trial NCT05857007?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT05857007, the US trial registry maintained by the National Library of Medicine. NCT05857007 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.