Skip to main content
OpenTrials
Completed

NCT Number: NCT00486681

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus Blood Glucose Endocrine System Diseases Glucose Metabolism Disorders Hospital Information Systems Medical Device Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Grenoble

Grenoble, 38000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No glucose monitoring needed

Treatment and study plan

Accu Chek Inform and Cobas IT 1000

Device

period II (warning activated)

Other names: Accu Chek Inform

Primary outcomes

  1. compare glycemic control of patients hospitalized in 3 departments

    Time frame: hospitalisation period

Secondary outcomes

  1. number of glycemia controls

    Time frame: hospitalisation period

  2. number of traceable glycemia readings

    Time frame: hospitalisation period

  3. number of hypoglycemia events and frequency of measures taken

    Time frame: hospitalisation period

  4. mean of % of glycemia for patients in warning phase with or without diabetologist intervention

    Time frame: hospitalisation period

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Assistance Medico-Technique A Domicile
  • Roche Diagnostics Meylan France

Registry information

Official study 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

Acronym: COBAS

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Jun 15, 2007
Registry last updated
Mar 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.