Official Title: “A Clinical Study to Evaluate the Use of Episodic, Intensive Blood Glucose Monitoring in Persons With Non-Insulin Treated Type 2 Diabetes”

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.

Study Type: Interventional

Study Design: Diagnostic, Randomized, Open Label, Parallel Assignment

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• No Intervention: 2

Primary Measures

• Change in HbA1c levels from baseline
  • Time Frame: 12 months
    Safety Issue?: No

Secondary 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
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 35 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hoffmann-La Roche

Overall Clinical Trial Officials and Contacts

Overall Contact: Please Reference Study ID Number: RD000590 973-235-5000 

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00674986

Study ID Number: RD000590

ClinicalTrials.gov Identifier: NCT00674986

Health Authority: United States: Institutional Review Board