NCT00486681

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
949

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 15, 2007

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

March 4, 2008

Status Verified

February 1, 2008

Enrollment Period

6 months

First QC Date

June 14, 2007

Last Update Submit

February 26, 2008

Conditions

Diabetes MellitusBlood GlucoseHospital Information SystemsMedical Device

Keywords

Glucose monitoringDiabetes managementInformation systemIn-patient glycemic control

Outcome Measures

Primary Outcomes (1)

  • compare glycemic control of patients hospitalized in 3 departments

    hospitalisation period

Secondary Outcomes (4)

  • number of glycemia controls

    hospitalisation period

  • number of traceable glycemia readings

    hospitalisation period

  • number of hypoglycemia events and frequency of measures taken

    hospitalisation period

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

    hospitalisation period

Study Arms (2)

1

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

2

period II (warning activated).

Device: Accu Chek Inform and Cobas IT 1000

Interventions

Accu Chek Inform and Cobas IT 1000DEVICE

period II (warning activated)

Also known as: Accu Chek Inform
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients requiring a monitoring of capillary blood glucose levels

You may qualify if:

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

You may not qualify if:

  • No glucose monitoring needed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Grenoble

Grenoble, 38000, France

Location

Related Publications (7)

  • 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.

    PMID: 15758007BACKGROUND

  • 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.

    PMID: 16873812BACKGROUND

  • 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.

    PMID: 15793210BACKGROUND

  • 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.

    PMID: 14747243BACKGROUND

  • 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.

    PMID: 9881230BACKGROUND

  • 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.

    PMID: 9727886BACKGROUND

  • 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

    BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • NELLY WION, MD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 14, 2007

First Posted

June 15, 2007

Study Start

January 1, 2007

Primary Completion

July 1, 2007

Study Completion

January 1, 2008

Last Updated

March 4, 2008

Record last verified: 2008-02

Locations

FR(1)