Clinical Assessment of an in-Patient Glucose Monitoring System (Accu-Chek Inform Cobas IT 1000) (COBAS)
February 26, 2008 updated by: University Hospital, Grenoble
Evaluation of the Implementation of the Accu-Chek Inform Cobas IT 1000 System in Three Medical Hospital Departments: Impact on the Management of Diabetes
The principal objective of this single-center 2-period study is to evaluate the glycemic control of in-patients in 3 hospital departments (Diabetology, Cardiology and Pulmonary Care) as the rate of capillary blood glucose measurements within a pre-define target range, and to compare results during the period I (warning of the Accu-Check Inform glucose meter on glucose levels not activated) and period II (warning activated).
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The study is a 6-month large scale assessment of an information system consisting in a glucose meter with multiple alerts (Accu-Chek Inform) associated with a data base (Cobas IT 1000) in order to share the results of glucose monitoring using the hospital information network.
The appraisal of the glycemic control was based on the rate of capillary blood glucose measurements within a pre-defined target range (3.9-8.5 mMol/l) during each study period.
Whether the system implementation can improve the outcome related to the management of in-patients with diabetes is assessed in 3 hospital departments (Diabetology, Cardiology and Pulmonary Care) as follows:
- principal objective, glycemic control of in-patients (Cardiology and Pulmonary Care) as the rate of capillary blood glucose (CBG) values within the pre-defined target range, and comparison of results observed during period I (meter warning not activated) and period II (warning of the meter on out-of-target glucose level activated).
- the impact on the performance of quality controls of CBG measurements with (period II) or without (period I) activation of a warning on the meter related to inappropriate quality control frequency (all departments).
- evaluate the traceability of CBG results and compare it with (period II) or without (period I) the activation of the automatic record of data ensured by the Accu-Chek Inform meter and Cobas IT 1000 data base (all departments).
- during a sub-period of period II, the impact on patient glycemic control of the intervention of a diabetologist, determined by the activation of a warning sent to the physician in case of out of target CBG results via the Cobas IT 1000 data base (Cardiology and Pulmonary Care).
- the impact of the above warning activation plus diabetologist intervention on the incidence of low CBG.
Study Type
Observational
Enrollment (Actual)
949
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Grenoble, France, 38000
- University Hospital of Grenoble
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients requiring a monitoring of capillary blood glucose levels
Description
Inclusion Criteria:
- In-patients,
- Age > 18 years,
- Requiring a monitoring of capillary blood glucose levels
Exclusion Criteria:
- No glucose monitoring needed
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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1
period I (warning of the Accu-Check Inform glucose meter on glucose levels not activated)
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2
period II (warning activated).
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period II (warning activated)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
compare glycemic control of patients hospitalized in 3 departments
Time Frame: hospitalisation period
|
hospitalisation period
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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number of glycemia controls
Time Frame: hospitalisation period
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hospitalisation period
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number of traceable glycemia readings
Time Frame: hospitalisation period
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hospitalisation period
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number of hypoglycemia events and frequency of measures taken
Time Frame: hospitalisation period
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hospitalisation period
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mean of % of glycemia for patients in warning phase with or without diabetologist intervention
Time Frame: hospitalisation period
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hospitalisation period
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: NELLY WION, MD, University Hospital, Grenoble
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kucher N, Koo S, Quiroz R, Cooper JM, Paterno MD, Soukonnikov B, Goldhaber SZ. Electronic alerts to prevent venous thromboembolism among hospitalized patients. N Engl J Med. 2005 Mar 10;352(10):969-77. doi: 10.1056/NEJMoa041533.
- King H, Aubert RE, Herman WH. Global burden of diabetes, 1995-2025: prevalence, numerical estimates, and projections. Diabetes Care. 1998 Sep;21(9):1414-31. doi: 10.2337/diacare.21.9.1414.
- ACE/ADA Task Force on Inpatient Diabetes. American College of Endocrinology and American Diabetes Association Consensus statement on inpatient diabetes and glycemic control. Diabetes Care. 2006 Aug;29(8):1955-62. doi: 10.2337/dc06-9913. No abstract available.
- Inzucchi SE, Rosenstock J. Counterpoint: Inpatient glucose management: a premature call to arms? Diabetes Care. 2005 Apr;28(4):976-9. doi: 10.2337/diacare.28.4.976. No abstract available.
- Clement S, Braithwaite SS, Magee MF, Ahmann A, Smith EP, Schafer RG, Hirsch IB; American Diabetes Association Diabetes in Hospitals Writing Committee. Management of diabetes and hyperglycemia in hospitals. Diabetes Care. 2004 Feb;27(2):553-91. doi: 10.2337/diacare.27.2.553. No abstract available. Erratum In: Diabetes Care. 2004 Mar;27(3):856. Hirsh, Irl B [corrected to Hirsch, Irl B]. Diabetes Care. 2004 May;27(5):1255.
- Halimi S. [Benefits of blood glucose self-monitoring in the management of insulin-dependent (IDDM) and non-insulin-dependent diabetes (NIDDM). Analysis of the literature: mixed results]. Diabetes Metab. 1998 Nov;24 Suppl 3:35-41. French.
- Mise en place et conduite en France d'essais cliniques portant sur des dispositifs médicaux et dispositifs médicaux de diagnostic in vitro.Afssaps September 2006, 15. http://agmed.sante.gouv.fr
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
July 1, 2007
Study Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
June 14, 2007
First Submitted That Met QC Criteria
June 14, 2007
First Posted (Estimate)
June 15, 2007
Study Record Updates
Last Update Posted (Estimate)
March 4, 2008
Last Update Submitted That Met QC Criteria
February 26, 2008
Last Verified
February 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DCIC 05 51
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