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

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Blood Glucose; Diabetes Mellitus; Medical Device; Hospital Information Systems

Treatments: Device: Accu Chek Inform and Cobas IT 1000

Study type: Observational

Funder types: Other

Identifiers

NCT00486681

DCIC 05 51

Details and patient eligibility

About

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).

Full 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.

Enrollment: 949 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• No glucose monitoring needed

Trial design

949 participants in 2 patient groups

1

Description:

period I (warning of the Accu-Check Inform glucose meter on glucose levels not activated)

2

Description:

period II (warning activated).

Treatment:

Device: Accu Chek Inform and Cobas IT 1000