A Clinical Study to Evaluate the Use of Episodic, Intensive Blood Glucose Monitoring in Persons With Non-insulin Treated Type 2 Diabetes - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00674986

Purpose

This randomized, parallel group study will determine whether the use of episodic, intensive glucose monitoring via the Accu-Chek 360 view blood glucose analysis system has a positive effect on overall glycemic control. Patients will be randomized into either the 'usual care' group, or the 'interventional group' supplemented with the Accu-Chek 360 view blood glucose analysis system. The effect of each treatment regimen on glycemic control will be assessed by measurement of change in baseline HbA1c values at 12 months. The anticipated time on study treatment is 1 year, and the target sample size is 504 individuals.

Condition	Intervention
Diabetes Mellitus, Type 2	Device: Accu-Chek 360 View Blood Glucose Analysis Tool Device: Accu-Chek Aviva Meter

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	A Clinical Study to Evaluate the Use of Episodic, Intensive Blood Glucose Monitoring in Persons With Non-insulin Treated Type 2 Diabetes

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Dextrose Proparacaine Proparacaine hydrochloride

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Change in AbA1c levels from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluation of changes in patients' knowledge of diabetes, self-care behaviours, QoL, attitude and satisfaction with their diabetes care; cost effectiveness analysis; evaluation of treatment intensification and time to treatment intensification [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	522
Study Start Date:	March 2008
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Device: Accu-Chek 360 View Blood Glucose Analysis Tool Device: Accu-Chek Aviva Meter
No Intervention: B

Eligibility

Ages Eligible for Study:	25 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult patients >= 25 years of age
Type 2 diabetes for >= 1 year
A1c >= 7.5% and <= 11.0%
Diabetes managed by exercise and diet, prescription oral medication or an injectable incretin mimetic

Exclusion Criteria:

Type 1 diabetes
On any type of insulin therapy at start of study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00674986

Show 29 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Linda Amstutz

Roche Diagnostics Corporation

More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fisher L, Polonsky W, Parkin CG, Jelsovsky Z, Amstutz L, Wagner RS. The impact of blood glucose monitoring on depression and distress in insulin-naïve patients with type 2 diabetes. Curr Med Res Opin. 2011 Nov;27 Suppl 3:39-46. Epub 2011 Sep 14.

Polonsky WH, Fisher L, Schikman CH, Hinnen DA, Parkin CG, Jelsovsky Z, Petersen B, Schweitzer M, Wagner RS. Structured self-monitoring of blood glucose significantly reduces A1C levels in poorly controlled, noninsulin-treated type 2 diabetes: results from the Structured Testing Program study. Diabetes Care. 2011 Feb;34(2):262-7.

Polonsky W, Fisher L, Schikman C, Hinnen D, Parkin C, Jelsovsky Z, Amstutz L, Schweitzer M, Wagner R. The value of episodic, intensive blood glucose monitoring in non-insulin treated persons with Type 2 Diabetes: design of the Structured Testing Program (STeP) study, a cluster-randomised, clinical trial [NCT00674986]. BMC Fam Pract. 2010 May 18;11:37.

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00674986 History of Changes
Other Study ID Numbers:	RD000590, RDC-MI&A-01-2007
Study First Received:	May 7, 2008
Last Updated:	November 21, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on February 09, 2012