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Completed

NCT Number: NCT01130480

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 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.

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

Up to 70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Accu-Chek Integra Glucometer

Device

Primary outcomes

  1. HbA1c change between the baseline and end of study

    Time frame: From baseline to month 6

  2. Successful rate of blood glucose control (the proportion of patients with HbA1c <7%)

    Time frame: From baseline to month 6

Secondary outcomes

  1. SMBG frequency change between the baseline and the end of the study

    Time frame: From baseline to month 6

  2. Relationship between SMBG frequency change and blood glucose control

    Time frame: From baseline to month 6

  3. 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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 26, 2010
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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