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

Diabetes Mellitus Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01130480
• Other study ID #: RD000933
• Status: Completed
• Phase: N/A
• First received: May 19, 2010
• Last updated: April 3, 2017
• Start date: May 31, 2010
• Est. completion date: March 31, 2012

Study information

• Verified date: April 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 833
• Est. completion date: March 31, 2012
• Est. primary completion date: March 31, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 70 Years

Eligibility

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Device:
• Accu-Chek Integra Glucometer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c change between the baseline and end of study		From baseline to month 6
Primary	Successful rate of blood glucose control (the proportion of patients with HbA1c <7%)		From baseline to month 6
Secondary	SMBG frequency change between the baseline and the end of the study		From baseline to month 6
Secondary	Relationship between SMBG frequency change and blood glucose control		From baseline to month 6
Secondary	To evaluate the change of quality of life in the 6 months by the health questionnaire SF-36		From baseline to month 6