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...
Brief Summary
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: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
- Study Primary Completion Date: February 2010
Intervention(s) in this Clinical Trial
- Device: Accu-Chek 360 View Blood Glucose Analysis Tool
- Device: Accu-Chek Aviva Meter
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: A
- No Intervention: B
Outcome Measures for this Clinical Trial
Primary Measures
- Change in AbA1c levels from baseline
- Time Frame: 12 months
Safety Issue?: No
- Time Frame: 12 months
Secondary 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
Safety Issue?: No
- Time Frame: Throughout study
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 25 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Hoffmann-La Roche Industry
Overall Clinical Trial Officials and Contacts
Linda Amstutz Study Director Roche Diagnostics Corporation
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00674986
