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

April 23, 2024 updated by: Wake Forest University Health Sciences

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is comparing current standard of care blood glucose fingersticks or serum blood glucose collection to CGM data utilizing the Freestyle Libre 2.0 CGM. A recently conducted study of 8 critically ill patients with diabetes that wore Freestyle Libre 2.0 CGM's during their ICU stay demonstrated high test-retest reliability and acceptable accuracy when compared with arterial blood glucose measurements. The study aims to evaluate utilization of CGM technology and EndoTool in the critical care setting by recruiting a cohort of 10 participants with hyperglycemia and/or diabetes mellitus who are anticipated to require blood glucose monitoring and IV insulin to achieve adequate glycemic control while in the Neuro ICU. The study also aims to evaluate utilization of CGM technology and subcutaneous insulin by recruiting a cohort of 10 patients with a history of diabetes mellitus on high dose steroids who are anticipated to require blood glucose monitoring and treatment with basal bolus insulin.

Participants will be enrolled on admission to the Neuro ICU and have the CGM device placed. The study aims to evaluate CGM technology by comparison of glucose values obtained from the CGM to the serum or fingerstick blood glucose levels while the patient is either receiving IV insulin via EndoTool or subcutaneous insulin while on high dose glucocorticoids. Current standard of care with monitoring glycemic data utilizing point of care blood glucose fingersticks and serum glucose will be utilized for comparison.

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • WakeForest University Health Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with hyperglycemia and/or diabetes mellitus with need of IV insulin management or subcutaneous insulin with concomitant high dose glucocorticoids who are admitted to the Neuro ICU at Atrium Health Wake Forest Baptist Hospital.

Description

Inclusion Criteria:

  • Participants that are 18 years of age or older with hyperglycemia and/or diabetes mellitus with need of IV insulin management or subcutaneous insulin with concomitant high dose glucocorticoids who are admitted to the Neuro ICU at Atrium Health Wake Forest Baptist Hospital.

Exclusion Criteria:

  • Pregnant women will be excluded from this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Libre 2.0 CGM in patients taking EndoTool IV insulin
Ten patients with Hyperglycemia or/and Diabetes in the neuro ICU requires IV insulin through EndoTool algorithm will wear Libre 2.0 CGM for either 14 days or their stay in the neuro ICU
Device: Libre 2.0 CGM in patients taking subcutaneous insulin with concomitant high dose glucocorticoids
Ten patients with hyperglycemia or/and diabetes in the neuro ICU requires subcutaneous insulin with concomitant high dose glucocorticoids will wear Libre 2.0 CGM for either 14 days or their stay in the neuro ICU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of CGM with fingerstick blood glucose values in critical care setting.
Time Frame: Participants will wear CGM for either 14 consecutive days or duration of their Neuro ICU admission
Neuro ICU patients with hyperglycemia, DKA or HHS and require either EndoTool IV insulin or subcutaneous insulin with concurrent high dose glucocorticoids, 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. Comparison of glucose values from CGM technology and the standard of care fingerstick blood glucose values will be performed.
Participants will wear CGM for either 14 consecutive days or duration of their Neuro ICU admission
Feasibility of CGM technology- 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.
Time Frame: Participants will wear CGM for either 14 consecutive days or duration of their Neuro ICU admission
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.
Participants will wear CGM for either 14 consecutive days or duration of their Neuro ICU admission
Feasibility of CGM technology in the critical care setting - monitor glucose during their hospitalization and studying if this data could improve subcutaneous insulin titration
Time Frame: Participants will wear CGM for either 14 consecutive days or duration of their Neuro ICU admission
Neuro ICU patients with hyperglycemia, DKA or HHS and require subcutaneous insulin with concurrent high dose glucocorticoids, 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 subcutaneous insulin titration . Dosing of insulin will be performed utilizing standard of care fingerstick blood glucose values and not CGM data.
Participants will wear CGM for either 14 consecutive days or duration of their Neuro ICU admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Catherine E Price, MD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

April 27, 2023

First Submitted That Met QC Criteria

May 3, 2023

First Posted (Actual)

May 12, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00087771

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article after deidentification (text, tables, figures, and appendices)

IPD Sharing Time Frame

Beginning 3 months and ending 5 years following article publication

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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