Diabetes Mellitus Type 2
Conditions
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.
Interventions
DEVICEAccu-Chek Integra Glucometer
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To evaluate the change of quality of life in the 6 months by the health questionnaire SF-36 | From baseline to month 6 |
| 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 |
Countries
China
Outcome results
None listed