Trial Information

Summary: Episodic intensive blood glucose monitoring in non-insulin treated type 2 diabetes.

Status: Recruiting

Protocol Number: RD000590

Sponsor:

Company Division: Diagnostic

Official Scientific Title: A clinical study to evaluate the use of episodic, intensive blood glucose monitoring in persons with non-insulin treated type 2 diabetes.

Brief 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 anticipiated time on study treatment is 1 year, and the target sample size is 504 individuals.

Study Phase: N/A

Study Design / Study Details:

• Purpose:
• Allocation: Randomized
• Masking: Open Label
• Control:
• Assignment: Parallel
• Endpoints:

Study Type:

Condition: Diabetes Mellitus, Type 2

Intervention Type: Diagnostic Test

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

Primary Outcome: Change in AbA1c levels from baseline. Timeframe: 12 months.

Key Secondary Outcomes: 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. Timeframe: Throughout study.

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 35 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: April, 2008

Trial Registration Date: 05/07/2008

Date Last Updated: 05/08/2008

Link To Trial Results

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Trial listings updated: December 2, 2008 at 3:17:35 PM