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

Diabetes Mellitus Clinical Trial

— COBAS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00486681
• Other study ID #: DCIC 05 51
• Status: Completed
• Phase: N/A
• First received: June 14, 2007
• Last updated: February 26, 2008
• Start date: January 2007
• Est. completion date: January 2008

Study information

• Verified date: February 2008
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 949
• Est. completion date: January 2008
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• In-patients,

• Age > 18 years,

• Requiring a monitoring of capillary blood glucose levels

Exclusion Criteria:

• No glucose monitoring needed

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Device:
• Accu Chek Inform and Cobas IT 1000
period II (warning activated)

Locations

Country	Name	City	State
France	University Hospital of Grenoble	Grenoble

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Assistance Medico-Technique A Domicile, Hoffmann-La Roche

Country where clinical trial is conducted

France, 

References & Publications (7)

ACE/ADA Task Force on Inpatient Diabetes. American College of Endocrinology and American Diabetes Association Consensus statement on inpatient diabetes and glycemic control. Diabetes Care. 2006 Aug;29(8):1955-62. Review. — View Citation

Clement S, Braithwaite SS, Magee MF, Ahmann A, Smith EP, Schafer RG, Hirsch IB; American Diabetes Association Diabetes in Hospitals Writing Committee. Management of diabetes and hyperglycemia in hospitals. Diabetes Care. 2004 Feb;27(2):553-91. Review. Erratum in: Diabetes Care. 2004 Mar;27(3):856. Hirsh, Irl B [corrected to Hirsch, Irl B]. Diabetes Care. 2004 May;27(5):1255. — View Citation

Halimi S. [Benefits of blood glucose self-monitoring in the management of insulin-dependent (IDDM) and non-insulin-dependent diabetes (NIDDM). Analysis of the literature: mixed results]. Diabetes Metab. 1998 Nov;24 Suppl 3:35-41. Review. French. — View Citation

Inzucchi SE, Rosenstock J. Counterpoint: Inpatient glucose management: a premature call to arms? Diabetes Care. 2005 Apr;28(4):976-9. Review. — View Citation

King H, Aubert RE, Herman WH. Global burden of diabetes, 1995-2025: prevalence, numerical estimates, and projections. Diabetes Care. 1998 Sep;21(9):1414-31. — View Citation

Kucher N, Koo S, Quiroz R, Cooper JM, Paterno MD, Soukonnikov B, Goldhaber SZ. Electronic alerts to prevent venous thromboembolism among hospitalized patients. N Engl J Med. 2005 Mar 10;352(10):969-77. — View Citation

Mise en place et conduite en France d'essais cliniques portant sur des dispositifs médicaux et dispositifs médicaux de diagnostic in vitro.Afssaps September 2006, 15. http://agmed.sante.gouv.fr

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare glycemic control of patients hospitalized in 3 departments		hospitalisation period	No
Secondary	number of glycemia controls		hospitalisation period	No
Secondary	number of traceable glycemia readings		hospitalisation period	No
Secondary	number of hypoglycemia events and frequency of measures taken		hospitalisation period	Yes
Secondary	mean of % of glycemia for patients in warning phase with or without diabetologist intervention		hospitalisation period	No