Clinical trial NCT05857007: CGM Utilization With IV Insulin EndoTool and Subcutaneous Insulin in the Neuro ICU
Official title: CGM Utilization With IV Insulin EndoTool and Subcutaneous Insulin in the Neuro ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: 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.
timeFrame: Participants will wear CGM for either 14 consecutive days or duration of their Neuro ICU admission
measure: Feasibility of CGM technology in the critical care setting - monitor glucose during their hospitalization and studying if this data could improve subcutaneous insulin titration
timeFrame: Participants will wear CGM for either 14 consecutive days or duration of their Neuro ICU admission
measure: Comparison of CGM with fingerstick blood glucose values in critical care setting.
timeFrame: Participants will wear CGM for either 14 consecutive days or duration of their Neuro ICU admission
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: WakeForest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Catherine E Price, MD
role: PRINCIPAL_INVESTIGATOR
References: