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

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”

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).

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.

Intervention(s) in this Clinical Trial

• Device: Accu Chek Inform and Cobas IT 1000
  • period II (warning activated)

Arms, Groups and Cohorts in this Clinical Trial

• : 1
  • period I (warning of the Accu-Check Inform glucose meter on glucose levels not activated)
• : 2
  • period II (warning activated).

Primary Measures

• compare glycemic control of patients hospitalized in 3 departments
  • Time Frame: hospitalisation period
    Safety Issue?: No

Secondary Measures

• number of glycemia controls
  • Time Frame: hospitalisation period
    Safety Issue?: No
• number of traceable glycemia readings
  • Time Frame: hospitalisation period
    Safety Issue?: No
• number of hypoglycemia events and frequency of measures taken
  • Time Frame: hospitalisation period
    Safety Issue?: Yes
• mean of % of glycemia for patients in warning phase with or without diabetologist intervention
  • Time Frame: hospitalisation period
    Safety Issue?: No

Inclusion Criteria:

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

Exclusion Criteria:

• No glucose monitoring needed

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University Hospital, Grenoble Other

Overall Clinical Trial Officials and Contacts

NELLY WION, MD Principal Investigator University Hospital, Grenoble  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00486681

Study ID Number: DCIC 05 51

ClinicalTrials.gov Identifier: NCT00486681

Health Authority: France: Afssaps - French Health Products Safety Agency