Clinical Assessment of an in-Patient Glucose Monitoring System (Accu-Chek Inform Cobas IT 1000) (COBAS)
|ClinicalTrials.gov Identifier: NCT00486681|
Recruitment Status : Completed
First Posted : June 15, 2007
Last Update Posted : March 4, 2008
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus Blood Glucose Hospital Information Systems Medical Device||Device: Accu Chek Inform and Cobas IT 1000|
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|
|Actual Enrollment :||949 participants|
|Official Title:||Evaluation of the Implementation of the Accu-Chek Inform Cobas IT 1000 System in Three Medical Hospital Departments: Impact on the Management of Diabetes|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||January 2008|
period I (warning of the Accu-Check Inform glucose meter on glucose levels not activated)
period II (warning activated).
Device: Accu Chek Inform and Cobas IT 1000
period II (warning activated)
Other Name: Accu Chek Inform
- compare glycemic control of patients hospitalized in 3 departments [ Time Frame: hospitalisation period ]
- number of glycemia controls [ Time Frame: hospitalisation period ]
- number of traceable glycemia readings [ Time Frame: hospitalisation period ]
- number of hypoglycemia events and frequency of measures taken [ Time Frame: hospitalisation period ]
- mean of % of glycemia for patients in warning phase with or without diabetologist intervention [ Time Frame: hospitalisation period ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00486681
|University Hospital of Grenoble|
|Grenoble, France, 38000|
|Principal Investigator:||NELLY WION, MD||University Hospital, Grenoble|