Optimization of Glycemic Control in the Hospital and Critical Care Setting

Development of a Comprehensive Clinical Decision Support System and Educational Tool to Support Optimization of Glycemic Control in the Hospital and Critical Care Setting

Continuous Glucose Monitoring collected using the iPro device, to complete a large dataset consisting of routine electronic health records, biological, neurophysiological, physiological, and glycemic data. This dataset will eventually contribute to the further development and optimization of a comprehensive simulation, training, and clinical decision support system designed to contribute the optimization of glycemic control in the hospital and critical care setting.

Although recent advances in technology such as electronic medical records and continuous glucose monitoring provide enhanced monitoring capabilities, optimal glycemic control in the hospital and critical care setting is still extremely difficult to obtain. These technologies provide little to no identification of trends in data, and clinical decision support.

The goal of this research study was to collect data to support further development and optimization of a comprehensive clinical decision support system with simulation, training, and clinical decision support functionality. The system will also be designed to provide real-time performance measurement and feedback to ensure glycemic control is maintained at an optimal level.

The continuous glucose monitor (CGM) device utilized in this investigation was the iPro Recorder® (Medtronic Diabetes, Northridge, CA), a FDA approved monitoring device which reports glucose values every five minutes.

Subjects with a history of hyperglycemia or current hyperglycemia were identified either in the intensive care unit or prior to surgery. Upon enrollment of eligible patients in the study, CGM device was placed on subject's abdomen or thigh. The times logged by the CGM device were synchronized to achieve valid data pairing according to time. Subjects were visited as needed or at least twice in a 24-hour period to ensure that the devices were still in place and comfortable for the patient. After 72 hours of data collection, the CGM device was removed and the area of attachment cleaned.

Research staff collected medical history and standard of care glucose point of care obtained during subject's participation into the study. Other data from the patient's standard of care monitor, such as oxygen saturation levels, blood pressure, respiratory and heart rate, were collected as part of the patient's safety assessment assurance.

Data analysis will be completed offsite by investigators at Aptima, Inc. and their wholly owned subsidiary, Analytic Diabetic Systems, LLC. All patient data collected in this investigation was appropriately de-identified.

Inclusion Criteria:

1. Male or Female, ≥ 18 years of age.
2. Subject able to provide written informed consent to participate in the study.
3. Female subject with a negative urine or serum pregnancy test, or not of childbearing potential, defined as surgically sterile due to bilateral tubal ligation, bilateral oophorectomy or hysterectomy; or are postmenopausal for at least 1 year.
4. Have a blood sugar value of >140 mg/dL or an glycosylated hemoglobin A1C (HbA1C) values >6.5% upon admission to the surgical Intensive Care Unit (ICU), medical ICU, or cardiovascular ICU, and have or not have been diagnosed with type 1 or type 2 diabetes.

Exclusion Criteria:

1. Subjects younger than 18 years old.
2. Subjects who are prisoners.
3. Subjects with known hypersensitivity to latex or tape.
4. Females who are pregnant or breastfeeding.
5. Subjects unable to provided informed consent.
6. Subjects unable to participate in the study for any reason in the opinion of the Principal Investigator.
7. Subjects enrolled in other research studies.