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

NCT ID: NCT05857007

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-19
• Study Completion Date: 2023-12-31

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. 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?

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.

Conditions

Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus; Hyperglycemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

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

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine E Price, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

WakeForest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

IRB00087771

Identifier Type: -

Identifier Source: org_study_id