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

Roche

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Device: Accu-Chek 360° View Blood Glucose Analysis Tool; Device: Accu-Chek Aviva Glucose Meter

Study type: Interventional

Funder types: Industry

Identifiers

NCT00674986

RD000590

RDC-MI&A-01-2007

Details and patient eligibility

About

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.

Enrollment: 522 patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients >= 25 years of age
• Type 2 diabetes for >= 1 year
• Hemoglobin 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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522 participants in 2 patient groups

Active Control Group (ACG)

Other group

Description:

Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.

Treatment:

Device: Accu-Chek Aviva Glucose Meter

Structured Testing Group (STG)

Experimental group

Description:

Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.

Treatment:

Device: Accu-Chek 360° View Blood Glucose Analysis Tool

Device: Accu-Chek Aviva Glucose Meter