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

Evaluation of the Implementation of the Accu-Chek Inform Cobas IT 1000 System in Three Medical Hospital Departments: Impact on the Management of Diabetes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00486681
Acronym
COBAS
Enrollment
949
Registered
2007-06-15
Start date
2007-01-31
Completion date
2008-01-31
Last updated
2008-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Glucose, Diabetes Mellitus, Hospital Information Systems, Medical Device

Keywords

Glucose monitoring, Diabetes management, Information system, In-patient glycemic control

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.

Interventions

DEVICEAccu Chek Inform and Cobas IT 1000

period II (warning activated)

Sponsors

Roche Diagnostics Meylan France
CollaboratorUNKNOWN
Assistance Medico-Technique A Domicile
CollaboratorOTHER
University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* No glucose monitoring needed

Design outcomes

Primary

MeasureTime frame
compare glycemic control of patients hospitalized in 3 departmentshospitalisation period

Secondary

MeasureTime frame
number of glycemia controlshospitalisation period
number of traceable glycemia readingshospitalisation period
number of hypoglycemia events and frequency of measures takenhospitalisation period
mean of % of glycemia for patients in warning phase with or without diabetologist interventionhospitalisation period

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026