Accu-Chek missiOn: SMBG in Patients With diAbetes on inSulin Study (COMPASS) - Multiple Center, Open, and Non-randomized Study
1 other identifier
interventional
833
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started May 2010
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2010
CompletedFirst Posted
Study publicly available on registry
May 26, 2010
CompletedStudy Start
First participant enrolled
May 31, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2012
CompletedApril 4, 2017
April 1, 2017
1.8 years
May 19, 2010
April 3, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
HbA1c change between the baseline and end of study
From baseline to month 6
Successful rate of blood glucose control (the proportion of patients with HbA1c <7%)
From baseline to month 6
Secondary Outcomes (3)
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
Study Arms (1)
A
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients unable or unwilling to comply with the requirements of the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Unknown Facility
Beijing, 100020, China
Unknown Facility
Beijing, 100034, China
Unknown Facility
Beijing, 100044, China
Unknown Facility
Beijing, 100730, China
Unknown Facility
Chengdu, 610041, China
Unknown Facility
Guangzhou, 510080, China
Unknown Facility
Guangzhou, 510120, China
Unknown Facility
Guangzhou, 510515, China
Unknown Facility
Hangzhou, 310003, China
Unknown Facility
Nanjing, 210008, China
Unknown Facility
Nanjing, 210029, China
Unknown Facility
Shanghai, 2000092, China
Unknown Facility
Shanghai, 200040, China
Unknown Facility
Shanghai, 200120, China
Unknown Facility
Shanghai, 200433, China
Unknown Facility
Shenyang, 110001, China
Unknown Facility
Tianjin, 300070, China
Unknown Facility
Wuhan, 430030, China
Unknown Facility
Xi'an, 710061, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bettina Petersen
Roche Diagnostics (Shanghai) Ltd
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2010
First Posted
May 26, 2010
Study Start
May 31, 2010
Primary Completion
March 31, 2012
Study Completion
March 31, 2012
Last Updated
April 4, 2017
Record last verified: 2017-04