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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01130480
First received: May 19, 2010
Last updated: August 26, 2014
Last verified: June 2010

May 19, 2010
August 26, 2014
May 2010
March 2012   (final data collection date for primary outcome measure)
  • HbA1c change between the baseline and end of study [ Time Frame: From baseline to month 6 ] [ Designated as safety issue: No ]
  • Successful rate of blood glucose control (the proportion of patients with HbA1c <7%) [ Time Frame: From baseline to month 6 ] [ Designated as safety issue: No ]
  • HbA1c change between baseline and end of study [ Time Frame: From baseline to month 6 ] [ Designated as safety issue: No ]
  • Successful rate of blood glucose control (the proportion of patients with HbA1c <7%) [ Time Frame: From baseline to month 6 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01130480 on ClinicalTrials.gov Archive Site
  • SMBG frequency change between the baseline and the end of the study [ Time Frame: From baseline to month 6 ] [ Designated as safety issue: No ]
  • Relationship between SMBG frequency change and blood glucose control [ Time Frame: From baseline to month 6 ] [ Designated as safety issue: No ]
  • To evaluate the change of quality of life in the 6 months by the health questionnaire SF-36 [ Time Frame: From baseline to month 6 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Accu-Chek missiOn: SMBG in Patients With diAbetes on inSulin Study (COMPASS) - Multiple Center, Open, and Non-randomized Study
Accu-Chek missiOn: SMBG in Patients With diAbetes on inSulin Study (COMPASS) - Multiple Center, Open, and Non-randomized Study

COMPASS is a status and intervention study for the self-monitoring of blood gluc ose (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 blo od glucose control and its influencing factors with the help of Accu-Chek Integr a 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 anti cipated duration of the study is 6 months.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Diabetes Mellitus, Type 2
Device: Accu-Chek Integra Glucometer
Experimental: A
Intervention: Device: Accu-Chek Integra Glucometer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
1 Year to 70 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01130480
RD000933
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Kurt Fan Roche Diagnostics (Shanghai) Ltd
Hoffmann-La Roche
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP