Episodic Intensive Blood Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes - Full Text View

Sponsored by:	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: AccuChek Aviva Meter with use of Accu-Chek 360 view blood glucose analysis system

MedlinePlus related topics: Diabetes

Drug Information available for: Dextrose

U.S. FDA Resources

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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Change in HbA1c 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 behaviors, 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 ]

Estimated Enrollment:	504
Study Start Date:	April 2008
Estimated Study Completion Date:	November 2008

Arms	Assigned Interventions
1: Experimental	Device: AccuChek Aviva Meter with use of Accu-Chek 360 view blood glucose analysis system
2: No Intervention

Eligibility

Ages Eligible for Study:	35 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients >=35 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

Contacts

Contact: Please Reference Study ID Number: RD000590	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

United States, Alabama
	Recruiting
Mobile, Alabama, United States
	Recruiting
Pell City, Alabama, United States
United States, Florida
	Recruiting
Chipley, Florida, United States
	Recruiting
Marrianna, Florida, United States
	Recruiting
Pembroke Pines, Florida, United States
United States, Georgia
	Recruiting
Atlanta, Georgia, United States
United States, Illinois
	Recruiting
O'Fallon, Illinois, United States
United States, Indiana
	Recruiting
Fishers, Indiana, United States
	Recruiting
Indianopolis, Indiana, United States
United States, North Carolina
	Recruiting
Hickory, North Carolina, United States
United States, Ohio
	Recruiting
Cuyahoga Falls, Ohio, United States
	Recruiting
Zanesville, Ohio, United States
United States, Pennsylvania
	Recruiting
Pottstown, Pennsylvania, United States
United States, South Carolina
	Recruiting
High Point, South Carolina, United States
	Recruiting
Lancaster, South Carolina, United States
United States, Tennessee
	Recruiting
Crossville, Tennessee, United States
United States, Virginia
	Recruiting
Abingdon, Virginia, United States

Sponsors and Collaborators

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Study Director )
Study ID Numbers:	RD000590, RDC-MI&A-01-2007
Study First Received:	May 7, 2008
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00674986 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Proxymetacaine
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on May 07, 2009