Feasibility and Performance of Continuous Glucose Monitoring to Guide Computerized Insulin Infusion Therapy in Non-ICU Patients Receiving Corticosteroid Therapy and Specialized Nutrition

The objective of this pilot study is to assess the feasibility and performance of real-time CGM for titrating Continuous Insulin Infusion Therapy (CII) via: (1) evaluation of CGM glucose accuracy in oncology and post-transplant population receiving IV insulin therapy, and (2) assessing both nursing acceptance/convenience and patient satisfaction with CGM use. (3) Background and Rationale

Managing blood glucose in the hospital is challenging but important. Hypoglycemia and hyperglycemia have been associated with increased length of stay, decreased wound healing, and mortality. For patients experiencing severe hyperglycemia and for those with rapidly changing insulin requirement, insulin infusion therapy is considered a mainstay of hospital management. The short half-life of intravenous insulin allows for precise titration of insulin drip that is facilitated by frequent glucose monitoring. However CII therapy also poses unique challenges. Safe administration of insulin by this route is very labor intensive for the nursing staff. This is particularly true for patients receiving insulin drips on the general floor and step down unit where nursing/patient ratios are typically 1-4 to 1-6 .

Placing a CGM sensor on these patients would provide nursing staff with the ability to monitor blood glucose levels with minimal patient disruption for finger stick glucose checks. The use of CGM is endorsed by Endocrine Society's 2022 Guidelines to effectively achieve glycemic targets and reduce hypoglycemia in hospitalized patients. Adjunctive use of CGM in addition to POC testing has been described as safe and effective for patients receiving insulin drips.

In addition, utilizing insulin drips for days on, is burdensome for the patient due to hourly finger sticks and disruption of sleep and impaired wellbeing associated with the process. Evidence demonstrates decreasing sleep disruptions may reduce delirium, hypertension, and mortality and improve the overall patient experience. Current standard of care requires that patients receiving insulin infusions receives POC monitoring every 1-2 hours, day or night, resulting in significant pain associated with PPC testing and the need to wake patients up during their sleep. With the adjunctive use of CGM monitoring POC testing would be reduced to every 6 hours.

Lastly, safety is an important consideration. Hypoglycemia is a common complication of insulin therapy even with close monitoring. In our institution, last year there were 210 hypoglycemic events were recorded for patients receiving insulin infusions (~ 8.6% of patients on insulin drips). The causes are multifactorial, with significant contribution of those related to algorithm adjustment, however failure to keep with hourly POC due to time constraints and logistical barriers in workflow contributed.

A 2018 study found the average marginal cost for an inpatient stay with a hypoglycemic adverse event was $4,312 per event. This increase in cost is related to an increase in average length of stay, an increase of 38.9% in total charges, increase in likelihood of requiring skilled nursing care post discharge, and a 7% increase of in-hospital mortality.

Inclusion criteria

• Age >19 years old
• Patients with diabetes or stress induced hyperglycemia requiring continuous insulin infusion therapy, with anticipated duration of this therapy being > 24 hours. Specifically, we will include
• Patients with Type 2 diabetes; or if not previously diagnosed as having diabetes, HbA1c >7.0% (laboratory-measured at or since hospital admission or within prior 3-months).
• Type 1 diabetes, as well as atypical forms of diabetes (including pancreatectomy and pancreatitis) and
• Stress hyperglycemia defined as at least 1 blood glucose measurement >180 mg/dL since admission in a patient without history of diabetes, if CII is indicated per treating physician
• Insulin drip (CII) already initiated since admission or planned to be initiated
• Non-critical hospitalization with expected duration of CII > 24 hours at time of randomization
• Oncology and post-transplant population receiving IV insulin therapy

Exclusion criteria

• Inability to provide written consent
• Medically unstable patients receiving pressor therapy and ICU level of care.
• Patients transferred from ICU with an expected requirement for CII > 24 hours on a non-ICU floor are eligible)
• For women of childbearing potential: currently pregnant or breastfeeding
• Hypoxia (O2 saturation < 90 %) present at time of potential enrollment
• Hemoglobin < 7 mg/dL;
• Anasarca present at time of potential enrollment
• Use of hydroxyurea or high dose acetaminophen use of >4g daily as those are substances known to interfere with CGM system.
• eGFR < 20 mL/min or dialysis being received or planned
• Known allergy to medical grade adhesives or a skin condition that may impact CGM performance per investigator discretion
• Admission for Diabetic ketoacidosis or hyperosmolar hyperglycemic state

Nurse Participants:

• Adults aged 19 and older involved in the routine care of the patient participants
• Adequate proficiency to understand and provide informed consent in English