HyperglycemiaMAHINCT01763567
Feasibility Study to Evaluate Safety and Device Performance of the Hospital Glucose Management System (HGMS)
An observational study of Hyperglycemia, run by Medtronic MiniMed, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess safety and device performance of the Medtronic Hospital Glucose Management System (HGMS) for up to 72-hours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycemia
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Sep 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Adult patients admitted to the Intensive Care Unit (ICU) and on intravenous (IV) insulin therapy for the treatment of transient or diabetes-related hyperglycemia
Who may be able to join
- Subject is at least 18 years old
- Subject is admitted to the ICU
- Subject has a treatment regimen that includes a glucose target range of ≥140 mg/dl
- Subject has a treatment regimen that includes an intended continuous intravenous insulin for at least 24 hours
- Including patients with no previous diagnosis of Diabetes Mellitus
- Subject has anticipated life expectancy greater than 96 hours
- Subject has recent platelet count greater than 30,000 per micro-liter
Who cannot join
- Subject currently has a suspected or diagnosed medical condition that, in the opinion of the Investigator, warrants exclusion from the study or prevents the subject from completing the study
- Subject is currently participating in another investigational drug or device study
- Subject is pregnant, as determined by hospital admission
- Subject is receiving treatment that includes Hydroxyurea.
Trial locations and contacts
1 site in 1 country.
United States1 site
St Luke's Hospital Mid America Heart Institute
Kansas City, Missouri, 64111
About this study
Official title: A Multi-Phased, Multi-Center Study to Evaluate Safety and Device Performance of the Medtronic Hospital Glucose Management System (HGMS) in Critically Ill Adult Patients
The purpose of this study is to assess safety and device performance of the Medtronic Hospital Glucose Management System (HGMS) for up to 72-hours.
Read the detailed description
Assess safety and device performance of the Medtronic HGMS in the critically-ill setting and analyze the following:
- Device Performance:
- Functionality of HGMS
- Alerts/Alarms Specificity and Sensitivity
- System Workflow
- Safety:
- Descriptive statistics will be used to characterize safety events
- Moderate and severe anticipated device and procedure related adverse events
- All serious adverse events and unanticipated adverse device effects related events
- Conditions
- Hyperglycemia
- Keywords
- Medtronic, Diabetes, Hospital, Continuous Glucose Monitor, Intensive Care Unit
- Medical subject headings
- Hyperglycemia, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Performance: Accuracy of HGMS
Mean Absolute Relative Difference (MARD), calculated as the absolute difference of [(sensor glucose values - iSTAT glucose values) / iSTAT glucose values].
The portable i-STAT handheld makes patient-side testing easy:
- Requires no special sample preparation or user calibration; maintenance is minimal
- Weighs 18 ounces, making it portable
- Patient-side testing is as easy as entering the operator and patient information into the handheld, inserting one of the several filled test cartridges, and then viewing test results:
- The system prompts users step by step through the testing process
- Operator and patient information can be entered via barcode scanner
- Operator lockout prevents unauthorized users from performing or viewing test results
- Test results are uploaded automatically when the i-STAT handheld is placed in a downloader
Measured: up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startMar 2012
- Primary completionAug 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mikhail Kosiborod, M.D, Principal investigator, St Luke's Hospital - Mid America Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763567
- Sponsor's protocol ID
- CEP244
- Acronym
- MAHI
- Status last verified
- May 2015
- First submitted
- 21 Dec 2012
- Last updated
- 7 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kosiborod M, Gottlieb RK, Sekella JA, Peterman D, Grodzinsky A, Kennedy P, Borkon MA. Performance of the Medtronic Sentrino continuous glucose management (CGM) system in the cardiac intensive care unit. BMJ Open Diabetes Res Care. 2014 Jul 21;2(1):e000037. doi: 10.1136/bmjdrc-2014-000037. eCollection 2014.
PubMed 25452874
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Phased, Multi-Center Study to Evaluate Safety and Device Performance of the Medtronic Hospital Glucose Management System (HGMS) in Critically Ill Adult Patients
- ClinicalTrials.gov ID
- NCT01763567
- Acronym / sponsor ID
- MAHI / CEP244
- Conditions
- Hyperglycemia
- Keywords
- Medtronic, Diabetes, Hospital, Continuous Glucose Monitor, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 9 Jan 2013 (estimated)
- Results
- Posted 7 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess safety and device performance of the Medtronic Hospital Glucose Management System (HGMS) for up to 72-hours.
Detailed description
Assess safety and device performance of the Medtronic HGMS in the critically-ill setting and analyze the following:
- Device Performance:
- Functionality of HGMS
- Alerts/Alarms Specificity and Sensitivity
- System Workflow
- Safety:
- Descriptive statistics will be used to characterize safety events
- Moderate and severe anticipated device and procedure related adverse events
- All serious adverse events and unanticipated adverse device effects related events
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the Intensive Care Unit (ICU) and on intravenous (IV) insulin therapy for the treatment of transient or diabetes-related hyperglycemia
Key inclusion criteria (7 listed)
- Subject is at least 18 years old
- Subject is admitted to the ICU
- Subject has a treatment regimen that includes a glucose target range of ≥140 mg/dl
- Subject has a treatment regimen that includes an intended continuous intravenous insulin for at least 24 hours
- Subject has anticipated life expectancy greater than 96 hours
Key exclusion criteria (4 listed)
- Subject currently has a suspected or diagnosed medical condition that, in the opinion of the Investigator, warrants exclusion from the study or prevents the subject from completing the study
- Subject is currently participating in another investigational drug or device study
- Subject is pregnant, as determined by hospital admission
- Subject is receiving treatment that includes Hydroxyurea.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Device Performance: Accuracy of HGMS
Time frame: up to 72 hours
Mean Absolute Relative Difference (MARD), calculated as the absolute difference of [(sensor glucose values - iSTAT glucose values) / iSTAT glucose values]. The portable i-STAT handheld makes patient-side testing easy: * Requires no special sample preparation or user calibration; maintenance is minimal * Weighs 18 ounces, making it portable * Patient-side testing is as easy as entering the operator and patient information into the handheld, inserting one of the several filled test cartridges, and then viewing test results: * The system prompts users step by step through the testing process * Operator and patient information can be entered via barcode scanner * Operator lockout prevents unauthorized users from performing or viewing test results * Test results are uploaded automatically when the i-STAT handheld is placed in a downloader
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25452874Kosiborod M, Gottlieb RK, Sekella JA, Peterman D, Grodzinsky A, Kennedy P, Borkon MA. Performance of the Medtronic Sentrino continuous glucose management (CGM) system in the cardiac intensive care unit. BMJ Open Diabetes Res Care. 2014 Jul 21;2(1):e000037. doi: 10.1136/bmjdrc-2014-000037. eCollection 2014.
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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.
Mikhail Kosiborod, M.D principal investigator
St Luke's Hospital - Mid America Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperglycemia, run by Medtronic MiniMed, Inc. at 1 site in United States.
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 7 inclusion and 4 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 7 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 7 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Device Performance: Accuracy of HGMS (time frame: up to 72 hours). 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 NCT01763567, which also lists 1 linked publication.
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 7 May 2015.