Diabetes Mellitus Clinical Trial
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.
;
Observational Model: Case-Crossover, Time Perspective: Prospective
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