Optimization of Glycemic Control in the Hospital and Critical Care Setting

NCT04015388 | Completed FDA Device

• 1 other identifier: 2013H0285
• Study Type: observational
• Target: 127
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hyperglycemia; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• Ensure data collected has considerable quantity of hypoglycemia, normoglycemia, and hyperglycemia for algorithm model development and optimization.

  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.

  Glucose levels collected since placement of the iPro device (Hour 0) until removal of the ipro device (Hour 72)

Study Arms (1)

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.

Device: iPro Continuous Glucose Monitoring

Interventions

iPro Continuous Glucose Monitoring DEVICE

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.

Diabetes Mellitus / Hyperglycemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead

Related Publications (10)

• 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.

  PMID: 10868825 BACKGROUND

• 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.

  PMID: 24887924 BACKGROUND

• 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.

  PMID: 9107164 BACKGROUND

• 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.

  PMID: 16608860 BACKGROUND

• 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.

  PMID: 19318385 BACKGROUND

• 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.

  PMID: 16352960 BACKGROUND

• 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.

  PMID: 16096543 BACKGROUND

• 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.

  PMID: 15520847 BACKGROUND

• 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.

  PMID: 20828400 BACKGROUND

• 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.

  PMID: 23894489 BACKGROUND

MeSH Terms

Conditions

Hyperglycemia; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ravi Tripathi, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Assistant Professor

Study Record Dates

• First Submitted: July 6, 2019
• First Posted: July 11, 2019
• Study Start: August 19, 2014
• Primary Completion: August 2, 2016
• Study Completion: February 4, 2021
• Last Updated: February 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share