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Clinical Trial NCT04015388 for Hyperglycemia, Diabetes Mellitus is completed. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Ohio State UniversityOptimization of Glycemic Control in the Hospital and Critical Care Setting 127
Clinical Trial NCT04015388 was an observational study for Hyperglycemia, Diabetes Mellitus that is now completed. The study started on August 19, 2014, with plans to enroll 127 participants. Led by Ohio State University, the expected completion date was February 4, 2021. The latest data from ClinicalTrials.gov was last updated on February 11, 2021.
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 ...Show More
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 su...
Show MoreOfficial 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
Conditions
HyperglycemiaDiabetes MellitusPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- 2013H0285
NCT ID Number
Start Date (Actual)
2014-08-19
Last Update Posted
2021-02-11
Completion Date (Estimated)
2021-02-04
Enrollment (Estimated)
127
Study Type
Observational
Status
Completed
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Diabetes Mellitus / Hyperglycemia iPro Continuous Glucose Monitoring on subjects with blood sugar value \>140 mg/dL upon admission to the intensive care unit or who have been diagnosed with type 1 or type 2 diabetes or have glycosylated hemoglobin A1C (HbA1C) values \> 6.5% prior to admission. | iPro Continuous Glucose Monitoring iPro device is a continuous glucose monitoring (CGM) FDA approved device. This CGM device consists of a small recorder which reports glucose values every five minutes. This recorder is connected directly to a glucose sensor. The glucose-oxidase based sensor measures extracellular fluid in the subcutaneous tissue. The tiny and flexible sensors are typically inserted just beneath the skin, usually in the abdominal area...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Evaluate performance of glucose predictive models, clinical decision support algorithms, and performance measures in simulated real-time setting. | Glucose measurements collected (mg/dL) in the iPro device will be further analyzed to create an algorithm to predict glucose changes (hyperglycemia or hypoglycemia). | Glucose levels collected since placement of the iPro device (Hour 0) until removal of the ipro device (Hour 72) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Ensure data collected has considerable quantity of hypoglycemia, normoglycemia, and hyperglycemia for algorithm model development and optimization. | Glucose measurements collected (mg/dL) in the iPro device will be reviewed to confirmed that sufficient hyperglycemia or hypoglycemia episodes, as well as normal glucose values, were recorded. Available data will be used to create the algorithm to predict glucose changes. | Glucose levels collected since placement of the iPro device (Hour 0) until removal of the ipro device (Hour 72) |
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. | Correlate glucose measurements collected (mg/dL) in the iPro device with the glucose values collected as at standard of care for each study subject at the Ohio State University Wexner Medical Center (OSUWMC). | Glucose levels collected since placement of the iPro device (Hour 0) until removal of the ipro device (Hour 72) |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Male or Female, ≥ 18 years of age.
- Subject able to provide written informed consent to participate in the study.
- 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.
- 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.
- Subjects younger than 18 years old.
- Subjects who are prisoners.
- Subjects with known hypersensitivity to latex or tape.
- Females who are pregnant or breastfeeding.
- Subjects unable to provided informed consent.
- Subjects unable to participate in the study for any reason in the opinion of the Principal Investigator.
- Subjects enrolled in other research studies.
Ohio State University456 active studies to exploreStudy Responsible Party
Ravi Tripathi, Principal Investigator, Principal Investigator, Clinical Assistant Professor, Ohio State University
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