Using a prospective, mixed methods study design, the investigators will assess the feasibility, usefulness, and care team acceptability of CGM in conjunction with FSBG during implementation of the new subQ DKA/HHS protocol at Regions Hospital. This will include evaluating how many patients agree to have a CGM device placed, time to place the CGM devices, CGM impact on length of stay, level of care required, frequency of alerts to changing glucose levels events, and assessing the match between CGM and FSBG readings done in the inpatient setting. Results will help inform cost effective, safe, patient-centered strategies, while gauging care team satisfaction to optimize DKA and HHS management in the future.
Diabetic ketoacidosis (DKA) and Hyperosmolar Hyperglycemic State (HHS) are severe complications of diabetes mellitus and one of the most common causes of hospital admission among people with diabetes. Up to now, the standard of care for managing DKA and HHS at Regions Hospital has involved intravenous (IV) insulin to treat hyperglycemia. However, the use of IV insulin is associated with increased care team resource utilization and the potential for adverse events such as hypoglycemia. Regions Hospital is in the process of implementing a new subcutaneous (subQ) insulin protocol, which has the potential to reduce resource utilization and improve patient safety, while producing similar outcomes for patients. One critical part of the new protocol is reducing the frequency of point of care capillary blood glucose monitoring, commonly known as a Finger Stick Blood Glucose test (FSBG) from hourly (Q1) to every 4 hours (Q4). The use of subQ insulin with less frequent blood sugar monitoring is possible owing to subQ insulin's slower mechanism of action than the IV insulin. Protocols have been shown to be safe within other hospital systems. However, the change from Q1 to Q4 monitoring of blood sugars does lead to some concern on the part of providers about correcting hyperglycemia too slowly or failing to recognize impending hypoglycemic events. The use of Continuous Glucose Monitoring (CGM) technology has been proposed to provide continuous (i.e. every 5 mins) updates about patient glucose levels in between FSBG checks in patients being treated for mild to moderate DKA or HHS. This continuous monitoring would help provide prompt identification of hypoglycemic episodes and improve safety during hospitalization, a change that could provide peace of mind to care providers and patients as the change is made from Q1 to Q4 FSBG. Using a prospective, mixed methods study design, the investigators will assess the feasibility, usefulness, and care team acceptability of CGM in conjunction with FSBG during implementation of the new subQ DKA/HHS protocol at Regions Hospital. This will include evaluating how many patients agree to have a CGM device placed, time to place the CGM devices, CGM impact on length of stay, level of care required, frequency of alerts to changing glucose levels events, and assessing the match between CGM and FSBG readings done in the inpatient setting. Results will help inform cost effective, safe, patient-centered strategies, while gauging care team satisfaction to optimize DKA and HHS management in the future.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
CGM devices will be set to alert the care team when interstitial glucose levels hit 250 mg/dL and 150 mg/dL. Dexcom 7s automatically alert when glucose levels are 55 mg/dL or lower. Nurses will be instructed to check the glucose trends on the CGM device when alerted. They will be asked to check glucose levels with a FSBG according to the following instructions: 1. CGM alerts to interstitial glucose level of 250 mg/dL AND trend indicates rapidly decreasing glucose levels (indicated by double down arrow on Dexcom 7) 2. CGM alerts to interstitial glucose level of 150 mg/dL or less.
Regions Hospital
Saint Paul, Minnesota, United States
Determine feasibility of CGM placement by hospital staff for patients experiencing hyperglycemia
Recruitment, overall participation, and completion rate.
Time frame: Duration of hospital stay from admission to discharge (average of 4 days).
Determine feasibility of CGM placement by hospital staff for patients experiencing hyperglycemia
Time to place CGM (time from admission, time from insulin administration).
Time frame: From time of admission until the time of first insulin administration by CGM (average of 2 hours).
Evaluate patient safety and care outcomes related to use of CGM during hospitalization
Length of hospital stay (ED, ICU, and/or Non-ICU)
Time frame: Duration of hospital stay from admission to discharge (average of 4 days).
Evaluate patient safety and care outcomes related to use of CGM during hospitalization
Time until DKA/HHS resolution
Time frame: From admission to medical clearance for discharge or transfer to another healthcare facility, whichever comes first (average of 4 days).
Describe accuracy and usefulness of CGM for monitoring resolution from hyperglycemia
Hits: how often does CGM device alert to glucose levels that are confirmed by FSBG to require intervention? Misses: how often does FSBG identify glucose levels that require intervention when CGM does not alert? False alarms: how often does CGM device alert when FSBG suggests no intervention is necessary? Nurse acceptability of CGM use: The investigators seek to measure care team acceptability of CGM during the treatment of patients with DKA/HHS by comparing their survey responses in reference to caring for patients who have CGM devices with alerts (Experimental group) vs patients who have CGM devices without alerts (Control group).
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Time frame: Duration of hospital stay from admission to discharge (average of 4 days).