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

Completed

• Conditions: Diabetes Mellitus; Blood Glucose; Hospital Information Systems; Medical Device
• Interventions: Device: Accu Chek Inform and Cobas IT 1000

• Registration Number: NCT00486681
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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).

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 Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-06-14
• Study First Submitted QC: 2007-06-14
• Study First Posted: 2007-06-15
• Primary Completion: 2007-07
• Study Completion: 2008-01
• Status Verified: 2008-02
• Last Update Submitted: 2008-02-26
• Last Update Posted: 2008-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 949

Inclusion Criteria

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

Exclusion Criteria

• No glucose monitoring needed

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2	Accu Chek Inform and Cobas IT 1000	period II (warning activated).

Primary Outcome Measures

Name	Time	Method
compare glycemic control of patients hospitalized in 3 departments	hospitalisation period

Secondary Outcome Measures

Name	Time	Method
number of glycemia controls	hospitalisation period
number of traceable glycemia readings	hospitalisation period
number of hypoglycemia events and frequency of measures taken	hospitalisation period
mean of % of glycemia for patients in warning phase with or without diabetologist intervention	hospitalisation period

Trial Locations

Locations (1)

University Hospital of Grenoble; 🇫🇷 Grenoble, France