The Use of Continuous Glucose Monitoring With Patients Undergoing a New Subcutaneous Insulin Protocol for Mild to Moderate Diabetic Ketoacidosis or Hyperosmolar Hyperglycemic State
概览
- 阶段
- 不适用
- 干预措施
- CGM with alerts
- 疾病 / 适应症
- Diabetic Ketoacidosis
- 发起方
- HealthPartners Institute
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Determine feasibility of CGM placement by hospital staff for patients experiencing hyperglycemia
- 状态
- 撤回
- 最后更新
- 上个月
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •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
- •HCO3 ≥ 12
排除标准
- •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
- •Pregnancy
- •Severe sepsis or septic shock
- •AMS \> if patient cannot consent
- •Euglycemic DKA
研究组 & 干预措施
CGM with alerts
The experimental group will have a Dexcom 7 CGM placed by a trained and credentialed member of the research team, or by a trained care team member (e.g. nurse, physician, diabetes educator). 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 2. CGM alerts to interstitial glucose level of 150 mg/dL or less.
干预措施: CGM with alerts
CGM without alerts
The control group will have a Dexcom 7 CGM placed by a trained and credentialed member of the research team, or by a trained care team member (e.g. nurse, physician, diabetes educator). The control group will have the device placed and glucose levels will be collected, but the device will not be set to alert (though note that the Dexcom 7 CGM will always alert when glucose drops below 55 mg/dl, so this alert will exist for both groups).
结局指标
主要结局
Determine feasibility of CGM placement by hospital staff for patients experiencing hyperglycemia
时间窗: 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).
Determine feasibility of CGM placement by hospital staff for patients experiencing hyperglycemia
时间窗: Duration of hospital stay from admission to discharge (average of 4 days).
Recruitment, overall participation, and completion rate.
次要结局
- 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).)
- Describe accuracy and usefulness of CGM for monitoring resolution from hyperglycemia(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(Duration of hospital stay from admission to discharge (average of 4 days).)