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

NCT05857007 | Completed FDA Device

• 1 other identifier: IRB00087771
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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. 1.Is CGM technology data accurate compared to the current standard point of care among NeuroICU patients?
2. 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. 3.How CGM technology could help treating hyperglycemia in the NeuroICU with resultant improvement in patient morbidity, mortality, and length of stay?

Conditions

Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus; Hyperglycemia

Keywords

CGM; IV insulin; EndoTool; subcutaneous insulin; continuous glucose monitoring; NeuroICU; critical care settings; Libre2

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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

• Comparison of CGM with fingerstick blood glucose values in critical care setting.

  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

Study Arms (1)

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

Interventions

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

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

Libre 2.0 CGM in patients taking EndoTool IV insulin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Pregnant women will be excluded from this study.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

WakeForest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Hyperglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Catherine E Price, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 12, 2023
• Study Start: July 19, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal

Locations

US (1)