Continuous Glucose Monitoring in Medical and Open-Heart Surgical Patients
Overview
- Phase
- Not Applicable
- Intervention
- CGM monitor
- Conditions
- Hyperglycemia
- Sponsor
- Parkview Health
- Enrollment
- 80
- Primary Endpoint
- CGM vs point of care test (POCT) glucose
- Status
- Withdrawn
- Last Updated
- 9 days ago
Overview
Brief Summary
The purpose of this study is to contribute to current research regarding the feasibility and accuracy of CGM in the hospital setting for both the medical and cardiovascular intensive care (ICU) patient populations.
Detailed Description
The use of continuous glucose monitors (CGM) in the outpatient setting has dramatically increased as these devices continue to improve in both ease of use, accessibility, and accuracy. Federal Drug Administration (FDA) clearance of certain devices has now been granted in both pregnancy and automated insulin delivery systems. As the world has embraced the safety and efficacy of continuous glucose monitors in the outpatient setting, health systems have turned attention to the potential of utilizing these devices to improve glycemic control in the hospital setting. With the announcement of the FDA granting enforcement discretion regarding the use of CGM technology in the hospital setting during the COVID-19 pandemic, the result was an abundance of research evaluating the potential of CGM longevity in the hospital setting. The Standards of Care in Diabetes: 2023 reported that "preliminary data suggests that CGM can significantly improve glycemic management and other hospital outcomes." Additionally, a systematic review of 32 studies evaluated the accuracy of CGM in the intensive care unit, with a consensus of moderate to good accuracy. CGM in the hospital setting could provide a valuable tool in reducing hypoglycemia, hyperglycemia, and increasing time spent in normoglycemia. Other potential benefits of CGM include a broader view of glucose patterns, capture of asymptomatic hypoglycemia, reduced length of stay, and decreased cost. The Diabetes Technology Society organized the Hospital Consensus Guideline Panel in 2020, with the final report including the recommendation for additional research on the accuracy, data management, and patient-centered outcomes of CGM use in the inpatient setting.
Investigators
Danielle Payne, FNP
Clinical Nurse Researcher & Nursing Research Program Coordinator
Parkview Health
Eligibility Criteria
Inclusion Criteria
- •Admitted patients 18 years of age or older
- •Glucose management per Glucommander and/or receiving POC blood glucose testing
- •Patients admitted to Medical 6 or elective or urgent open-heart surgery patients admitted to the Cardiovascular Intensive Care Unit (CVICU)
Exclusion Criteria
- •Patients less than 18 years of age
- •Pregnant or currently breastfeeding
- •Prisoners
- •Patients unable to consent in English.
- •Patients with a preexisting insulin pump on admission
- •Active skin infection at the insertion site(s)
Arms & Interventions
General medical inpatients
Medical inpatients who have a Glucommander order for management of hyperglycemia will have a CGM monitor placed within 24 hours of admission for up to 7 days or upon discharge.
Intervention: CGM monitor
Open-heart surgery inpatients
Patients having elective open-heart surgery including coronary artery bypass grafting (CABG), aortic valve repair/replacement (AVR), mitral valve repair/replacement (MVR), or any combination of those will have a CGM monitor placed within one hour of admission for up to 7 days or upon discharge.
Intervention: CGM monitor
Outcomes
Primary Outcomes
CGM vs point of care test (POCT) glucose
Time Frame: from date of admission up to 7 days
Continuous interstitial glucose monitor readings compared to point of care capillary blood glucose readings
Secondary Outcomes
- Slow downward trend arrow on CGM device(from date of admission up to 7 days)