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Clinical Assessment of an in-Patient Glucose Monitoring System (Accu-Chek Inform Cobas IT 1000) (COBAS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00486681
First Posted: June 15, 2007
Last Update Posted: March 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Roche Diagnostics Meylan France
Assistance Medico-Technique A Domicile
Information provided by:
University Hospital, Grenoble
  Purpose
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).

Condition Intervention
Diabetes Mellitus Blood Glucose Hospital Information Systems Medical Device Device: Accu Chek Inform and Cobas IT 1000

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • compare glycemic control of patients hospitalized in 3 departments [ Time Frame: hospitalisation period ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 949
Study Start Date: January 2007
Study Completion Date: January 2008
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
period I (warning of the Accu-Check Inform glucose meter on glucose levels not activated)
2
period II (warning activated).
Device: Accu Chek Inform and Cobas IT 1000
period II (warning activated)
Other Name: Accu Chek Inform

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients requiring a monitoring of capillary blood glucose levels
Criteria

Inclusion Criteria:

  • In-patients,
  • Age > 18 years,
  • Requiring a monitoring of capillary blood glucose levels

Exclusion Criteria:

  • No glucose monitoring needed
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00486681


Locations
France
University Hospital of Grenoble
Grenoble, France, 38000
Sponsors and Collaborators
University Hospital, Grenoble
Roche Diagnostics Meylan France
Assistance Medico-Technique A Domicile
Investigators
Principal Investigator: NELLY WION, MD University Hospital, Grenoble
  More Information

Publications:
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

Responsible Party: Nelly Wion, University Hospital of Grenoble
ClinicalTrials.gov Identifier: NCT00486681     History of Changes
Other Study ID Numbers: DCIC 05 51
First Submitted: June 14, 2007
First Posted: June 15, 2007
Last Update Posted: March 4, 2008
Last Verified: February 2008

Keywords provided by University Hospital, Grenoble:
Glucose monitoring
Diabetes management
Information system
In-patient glycemic control

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases