Text Size

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: October 10, 2012
Last verified: June 2010
History of Changes
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
 Device: Accu-Chek Integra Glucometer

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Accu-Chek missiOn: SMBG in Patients With diAbetes on inSulin Study (COMPASS) - Multiple Center, Open, and Non-randomized Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1000
Study Start Date: May 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Device: Accu-Chek Integra Glucometer

  Eligibility

Ages Eligible for Study:   1 Year to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01130480

Locations
China
Beijing, China, 100044
Beijing, China, 100034
Beijing, China, 100730
Beijing, China, 100020
Chengdu, China, 610041
Guangzhou, China, 510515
Guangzhou, China, 510080
Guangzhou, China, 510120
Hangzhou, China, 310003
Nanjing, China, 210029
Nanjing, China, 210008
Shanghai, China, 200040
Shanghai, China, 200120
Shanghai, China, 200433
Shanghai, China, 2000092
Shenyang, China, 110001
Tianjin, China, 300070
Wuhan, China, 430030
Xian, China, 710061
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Kurt Fan Roche Diagnostics (Shanghai) Ltd
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01130480     History of Changes
Other Study ID Numbers: RD000933
Study First Received: May 19, 2010
Last Updated: October 10, 2012
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013