Diabetes Mellitus Clinical Trial
— COBASOfficial 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
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).
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 |
Observational Model: Case-Crossover, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
France | University Hospital of Grenoble | Grenoble |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble | Assistance Medico-Technique A Domicile, Hoffmann-La Roche |
France,
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
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 |
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