Clinical trial NCT04015388: Optimization of Glycemic Control in the Hospital and Critical Care Setting
Official title: Development of a Comprehensive Clinical Decision Support System and Educational Tool to Support Optimization of Glycemic Control in the Hospital and Critical Care Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperglycemia
Diabetes Mellitus
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2019-07-11
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population included in this study were adult patients, with at least 18 years old, admitted in The Ohio State University Wexner Medical Center critical care setting. Subjects had a blood sugar value \>140 mg/dL upon admission to ICU or had been diagnosed with type 1 or type 2 diabetes or had glycosylated hemoglobin A1C (HbA1C) values \> 6.5% prior to admission.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate performance of glucose predictive models, clinical decision support algorithms, and performance measures in simulated real-time setting.
timeFrame: Glucose levels collected since placement of the iPro device (Hour 0) until removal of the ipro device (Hour 72)
Secondary outcomes:
measure: Ensure data collected has considerable quantity of hypoglycemia, normoglycemia, and hyperglycemia for algorithm model development and optimization.
timeFrame: Glucose levels collected since placement of the iPro device (Hour 0) until removal of the ipro device (Hour 72)
measure: Further development of GlyCU system functionality (simulation, training, and clinical decision support capabilities) and identification of necessary steps for integration with the OSUWMC electronic health record database.
timeFrame: Glucose levels collected since placement of the iPro device (Hour 0) until removal of the ipro device (Hour 72)
Other outcomes:
Locations:
Study officials:
affiliation: Ohio State University
name: Ravi Tripathi, MD
role: PRINCIPAL_INVESTIGATOR
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