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

NCT ID: NCT00486681

Last Updated: 2008-03-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 949 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2008-01-31

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.

Conditions

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

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

1

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

No interventions assigned to this group

2

period II (warning activated).

Accu Chek Inform and Cobas IT 1000

Intervention Type: DEVICE

period II (warning activated)

Interventions

Accu Chek Inform and Cobas IT 1000

period II (warning activated)

Intervention Type: DEVICE

Other Intervention Names

Accu Chek Inform

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• No glucose monitoring needed

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Diagnostics Meylan France

UNKNOWN

Sponsor Role: collaborator

Assistance Medico-Technique A Domicile

OTHER

Sponsor Role: collaborator

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

University Hospital of Grenoble

Principal Investigators

NELLY WION, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

University Hospital of Grenoble

Grenoble, , France

Countries

France

References

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. doi: 10.1056/NEJMoa041533.

Reference Type: BACKGROUND

PMID: 15758007 (View on PubMed)

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. doi: 10.2337/dc06-9913. No abstract available.

Reference Type: BACKGROUND

PMID: 16873812 (View on PubMed)

Inzucchi SE, Rosenstock J. Counterpoint: Inpatient glucose management: a premature call to arms? Diabetes Care. 2005 Apr;28(4):976-9. doi: 10.2337/diacare.28.4.976. No abstract available.

Reference Type: BACKGROUND

PMID: 15793210 (View on PubMed)

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. doi: 10.2337/diacare.27.2.553. No abstract available.

Reference Type: BACKGROUND

PMID: 14747243 (View on PubMed)

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. French.

Reference Type: BACKGROUND

PMID: 9881230 (View on PubMed)

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. doi: 10.2337/diacare.21.9.1414.

Reference Type: BACKGROUND

PMID: 9727886 (View on PubMed)

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

Reference Type: BACKGROUND

Other Identifiers

DCIC 05 51

Identifier Type: -

Identifier Source: org_study_id