Continuous Glucose Monitoring Using a New Subcutaneous Insulin Protocol for Mild to Moderate Diabetic Ketoacidosis
- Conditions
- Diabetic KetoacidosisHyperglycemia
- Registration Number
- NCT06693115
- Lead Sponsor
- HealthPartners Institute
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 18 years or older
- Presents at Regions Hospital ED including transfers from other hospitals
- Meets criteria for new subQ insulin protocol:
- Diagnosis of DKA or HHS (hyperosmolar hyperglycemic state) and provider decision to initiate insulin
- pH ≥ 7.1
- HCO3 ≥ 12
- Under 18 years of age
- Excluded from new subQ protocol, specifically:
- Acute CHF exacerbation
- Acute MI (ACS/NSTEMI type 1 not demand ischemia)
- CKD stage 4 or AKI with creatinine > 3
- ESLD
- Pregnancy
- Severe sepsis or septic shock
- AMS > if patient cannot consent
- Euglycemic DKA
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Determine feasibility of CGM placement by hospital staff for patients experiencing hyperglycemia From time of admission until the time of first insulin administration by CGM (average of 2 hours). Time to place CGM (time from admission, time from insulin administration).
- Secondary Outcome Measures
Name Time Method Evaluate patient safety and care outcomes related to use of CGM during hospitalization From admission to medical clearance for discharge or transfer to another healthcare facility, whichever comes first (average of 4 days). Time until DKA/HHS resolution
Describe accuracy and usefulness of CGM for monitoring resolution from hyperglycemia Duration of hospital stay from admission to discharge (average of 4 days). 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).
Trial Locations
- Locations (1)
Regions Hospital
🇺🇸Saint Paul, Minnesota, United States