Optimization of Glycemic Control in the Hospital and Critical Care Setting
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.