A Clinical Study to Evaluate the Use of Episodic, Intensive Blood Glucose Monitoring in Persons With Non-insulin Treated Type 2 Diabetes
NCT00674986 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 522
Last updated 2013-10-21
Summary
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.
Conditions
- Diabetes Mellitus, Type 2
Interventions
- DEVICE
-
Accu-Chek 360° View Blood Glucose Analysis Tool
- DEVICE
-
Accu-Chek Aviva Glucose Meter
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bettina Petersen · Roche Diagnostics GmbH
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 25 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-03-31
- Primary Completion
- 2010-02-28
- Completion
- 2010-02-28
Countries
- United States
Study Locations
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