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

NCT ID: NCT01130480

Last Updated: 2017-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

833 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus Type 2

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Accu-Chek Integra Glucometer

Intervention Type DEVICE

Interventions

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Accu-Chek Integra Glucometer

Intervention Type DEVICE

Eligibility Criteria

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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
Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bettina Petersen

Role: STUDY_DIRECTOR

Roche Diagnostics (Shanghai) Ltd

Locations

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Beijing, , China

Site Status

Beijing, , China

Site Status

Beijing, , China

Site Status

Beijing, , China

Site Status

Chengdu, , China

Site Status

Guangzhou, , China

Site Status

Guangzhou, , China

Site Status

Guangzhou, , China

Site Status

Hangzhou, , China

Site Status

Nanjing, , China

Site Status

Nanjing, , China

Site Status

Shanghai, , China

Site Status

Shanghai, , China

Site Status

Shanghai, , China

Site Status

Shanghai, , China

Site Status

Shenyang, , China

Site Status

Tianjin, , China

Site Status

Wuhan, , China

Site Status

Xi'an, , China

Site Status

Countries

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China

Other Identifiers

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RD000933

Identifier Type: -

Identifier Source: org_study_id

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