HyperglycemiaNCT04015388
Optimization of Glycemic Control in the Hospital and Critical Care Setting
An observational study of Hyperglycemia and Diabetes Mellitus, run by Ohio State University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycemia, Diabetes Mellitus
- What is being tested?
- iPro Continuous Glucose Monitoring
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 127 participants
- Where
- No sites listed yet
- Study dates
- 19 Aug 2014to 4 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
Read the 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.
- Conditions
- Hyperglycemia, Diabetes Mellitus
- Being tested
- iPro Continuous Glucose Monitoring
- Medical subject headings
- Hyperglycemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPro Continuous Glucose MonitoringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: iPro Continuous Glucose Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 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.
Measured: 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).
Measured: Glucose levels collected since placement of the iPro device (Hour 0) until removal of the ipro device (Hour 72)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start19 Aug 2014
- Primary completion2 Aug 2016
- Study completion4 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ravi Tripathi, Ohio State University
- Investigators
- Ravi Tripathi, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015388
- Sponsor's protocol ID
- 2013H0285
- Status last verified
- Feb 2021
- First submitted
- 6 Jul 2019
- Last updated
- 11 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 10868825Engoren 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.
PubMed 24887924Giugliano 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.
PubMed 9107164Ingels 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.
PubMed 16608860Inzucchi 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.
PubMed 19318385Kanji 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.
PubMed 16352960Sung 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.
PubMed 16096543Van 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.
PubMed 15520847Pappada 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.
PubMed 20828400Pappada 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.
PubMed 23894489
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04015388
- Acronym / sponsor ID
- 2013H0285
- Conditions
- Hyperglycemia, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 19 Aug 2014 (actual)
- Primary completion
- 2 Aug 2016 (actual)
- Study completion
- 4 Feb 2021 (actual)
- First posted
- 11 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes Mellitus / Hyperglycemia | – | Device: iPro Continuous Glucose MonitoringiPro 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iPro Continuous Glucose MonitoringiPro 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. | Device | Diabetes Mellitus / Hyperglycemia |
Primary outcome
Evaluate performance of glucose predictive models, clinical decision support algorithms, and performance measures in simulated real-time setting.
Time frame: Glucose levels collected since placement of the iPro device (Hour 0) until removal of the ipro device (Hour 72)
Glucose measurements collected (mg/dL) in the iPro device will be further analyzed to create an algorithm to predict glucose changes (hyperglycemia or hypoglycemia).
2 secondary outcomes
Ensure data collected has considerable quantity of hypoglycemia, normoglycemia, and hyperglycemia for algorithm model development and optimization.
Time frame: 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.
Time frame: Glucose levels collected since placement of the iPro device (Hour 0) until removal of the ipro device (Hour 72)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Background: PubMed 10868825Cox 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.
- Background: PubMed 24887924Engoren 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.
- Background: PubMed 9107164Giugliano 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.
- Background: PubMed 16608860Ingels 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.
- Background: PubMed 19318385Inzucchi 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.
- Background: PubMed 16352960Kanji 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.
- Background: PubMed 16096543Sung 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.
- Background: PubMed 15520847Van 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.
- Background: PubMed 20828400Pappada 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.
- Background: PubMed 23894489Pappada 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ravi Tripathi, MD principal investigator
Ohio State University
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperglycemia and Diabetes Mellitus, run by Ohio State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate performance of glucose predictive models, clinical decision support algorithms, and performance measures in simulated real-time setting. (time frame: Glucose levels collected since placement of the iPro device (Hour 0) until removal of the ipro device (Hour 72)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04015388, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.