Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00674986
First received: May 7, 2008
Last updated: February 25, 2013
Last verified: June 2010
History of Changes
  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:

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
Active control group (ACG)
 Device: Accu-Chek 360 View Blood Glucose Analysis Tool
Cluster Randomized - Practices were randomized to an active control group (ACG) with enhanced usual care or a structured testing group (STG).
Device: Accu-Chek Aviva Meter
No Intervention: B
Structured testing group (STG)

  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%
  • 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):

Responsible Party: 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: February 25, 2013
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 May 16, 2013