Accu-Chek missiOn: SMBG in Patients With diAbetes on inSulin Study (COMPASS) - Multiple Center, Open, and Non-randomized Study

Not Applicable

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Device: Accu-Chek Integra Glucometer

• Registration Number: NCT01130480
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

COMPASS is a status and intervention study for the self-monitoring of blood glucose (SMBG) in type 2 diabetic patients with insulin treatment. This multi-centre, open-label prospective study will assess the use and frequency of SMBG and blood glucose control and its influencing factors with the help of Accu-Chek Integra glucometer. Patients with type 2 diabetes mellitus who have received more than 3 months of insulin therapy are eligible to participate in this study. The anticipated duration of the study is 6 months.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-19
• Study First Submitted QC: 2010-05-24
• Study First Posted: 2010-05-26
• Study Start: 2010-05-31
• Primary Completion: 2012-03-31
• Study Completion: 2012-03-31
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-03
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 833

Inclusion Criteria

• Type II diabetes mellitus patients who have received insulin treatment for more than 3 months
• Patients willing to sign written informed consent form
• Patients who meet the criteria for the first cross-sectional investigation and have an HbA1c < 7% will receive the second cross-sectional investigation

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Exclusion Criteria

• Patients unable or unwilling to comply with the requirements of the protocol

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Accu-Chek Integra Glucometer	-

Primary Outcome Measures

Name	Time	Method
Successful rate of blood glucose control (the proportion of patients with HbA1c <7%)	From baseline to month 6
HbA1c change between the baseline and end of study	From baseline to month 6

Secondary Outcome Measures

Name	Time	Method
SMBG frequency change between the baseline and the end of the study	From baseline to month 6
Relationship between SMBG frequency change and blood glucose control	From baseline to month 6
To evaluate the change of quality of life in the 6 months by the health questionnaire SF-36	From baseline to month 6