Optimization of Glycemic Control in the Hospital and Critical Care Setting
NCT ID: NCT04015388
Last Updated: 2021-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
127 participants
OBSERVATIONAL
2014-08-19
2021-02-04
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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, but can also be placed in the buttock, or anterior or lateral thigh.
Interventions
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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, but can also be placed in the buttock, or anterior or lateral thigh.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Ohio State University
OTHER
Responsible Party
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Ravi Tripathi
Principal Investigator, Clinical Assistant Professor
Principal Investigators
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Ravi Tripathi, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
References
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Cox DJ, Gonder-Frederick LA, Kovatchev BP, Julian DM, Clarke WL. Progressive hypoglycemia's impact on driving simulation performance. Occurrence, awareness and correction. Diabetes Care. 2000 Feb;23(2):163-70. doi: 10.2337/diacare.23.2.163.
Engoren M, Schwann TA, Habib RH. Elevated hemoglobin A1c is associated with readmission but not complications. Asian Cardiovasc Thorac Ann. 2014 Sep;22(7):800-6. doi: 10.1177/0218492313515895. Epub 2013 Dec 6.
Giugliano D, Marfella R, Coppola L, Verrazzo G, Acampora R, Giunta R, Nappo F, Lucarelli C, D'Onofrio F. Vascular effects of acute hyperglycemia in humans are reversed by L-arginine. Evidence for reduced availability of nitric oxide during hyperglycemia. Circulation. 1997 Apr 1;95(7):1783-90. doi: 10.1161/01.cir.95.7.1783.
Ingels C, Debaveye Y, Milants I, Buelens E, Peeraer A, Devriendt Y, Vanhoutte T, Van Damme A, Schetz M, Wouters PJ, Van den Berghe G. Strict blood glucose control with insulin during intensive care after cardiac surgery: impact on 4-years survival, dependency on medical care, and quality-of-life. Eur Heart J. 2006 Nov;27(22):2716-24. doi: 10.1093/eurheartj/ehi855. Epub 2006 Apr 11.
Inzucchi SE, Siegel MD. Glucose control in the ICU--how tight is too tight? N Engl J Med. 2009 Mar 26;360(13):1346-9. doi: 10.1056/NEJMe0901507. Epub 2009 Mar 24. No abstract available.
Kanji S, Buffie J, Hutton B, Bunting PS, Singh A, McDonald K, Fergusson D, McIntyre LA, Hebert PC. Reliability of point-of-care testing for glucose measurement in critically ill adults. Crit Care Med. 2005 Dec;33(12):2778-85. doi: 10.1097/01.ccm.0000189939.10881.60.
Sung J, Bochicchio GV, Joshi M, Bochicchio K, Tracy K, Scalea TM. Admission hyperglycemia is predictive of outcome in critically ill trauma patients. J Trauma. 2005 Jul;59(1):80-3. doi: 10.1097/01.ta.0000171452.96585.84.
Van den Berghe G. How does blood glucose control with insulin save lives in intensive care? J Clin Invest. 2004 Nov;114(9):1187-95. doi: 10.1172/JCI23506.
Pappada SM, Borst MJ, Cameron BD, Bourey RE, Lather JD, Shipp D, Chiricolo A, Papadimos TJ. Development of a neural network model for predicting glucose levels in a surgical critical care setting. Patient Saf Surg. 2010 Sep 9;4(1):15. doi: 10.1186/1754-9493-4-15.
Pappada SM, Cameron BD, Tulman DB, Bourey RE, Borst MJ, Olorunto W, Bergese SD, Evans DC, Stawicki SP, Papadimos TJ. Evaluation of a model for glycemic prediction in critically ill surgical patients. PLoS One. 2013 Jul 19;8(7):e69475. doi: 10.1371/journal.pone.0069475. Print 2013.
Other Identifiers
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2013H0285
Identifier Type: -
Identifier Source: org_study_id
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