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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: April 3, 2017
Last verified: April 2017
  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: Intervention Model: Single Group Assignment
Masking: None (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

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 ]
  • Successful rate of blood glucose control (the proportion of patients with HbA1c <7%) [ Time Frame: From baseline to month 6 ]

Secondary Outcome Measures:
  • SMBG frequency change between the baseline and the end of the study [ Time Frame: From baseline to month 6 ]
  • Relationship between SMBG frequency change and blood glucose control [ Time Frame: From baseline to month 6 ]
  • 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 ]

Enrollment: 833
Actual Study Start Date: May 31, 2010
Study Completion Date: March 31, 2012
Primary Completion Date: March 31, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Device: Accu-Chek Integra Glucometer

  Eligibility

Ages Eligible for Study:   up to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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: April 3, 2017

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

ClinicalTrials.gov processed this record on August 17, 2017