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

Primary Purpose

Diabetes Mellitus Type 2

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Accu-Chek Integra Glucometer

About this trial

This is an interventional diagnostic trial for Diabetes Mellitus Type 2

Eligibility Criteria

undefined - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

HbA1c change between the baseline and end of study

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

Secondary Outcome Measures

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

Relationship between SMBG frequency change and blood glucose control

To evaluate the change of quality of life in the 6 months by the health questionnaire SF-36

Full Information

NCT ID

NCT01130480

First Posted

May 19, 2010

Last Updated

April 3, 2017

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT01130480

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

May 31, 2010 (Actual)

Primary Completion Date

March 31, 2012 (Actual)

Study Completion Date

March 31, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus Type 2

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

833 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Accu-Chek Integra Glucometer

Primary Outcome Measure Information:

Title

HbA1c change between the baseline and end of study

Time Frame

From baseline to month 6

Title

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

Time Frame

From baseline to month 6

Secondary Outcome Measure Information:

Title

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

Time Frame

From baseline to month 6

Title

Relationship between SMBG frequency change and blood glucose control

Time Frame

From baseline to month 6

Title

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

10. Eligibility

Sex

All

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bettina Petersen

Organizational Affiliation

Roche Diagnostics (Shanghai) Ltd

Official's Role

Study Director

Facility Information:

City

Beijing

ZIP/Postal Code

100020

Country

China

City

Beijing

ZIP/Postal Code

100034

Country

China

City

Beijing

ZIP/Postal Code

100044

Country

China

City

Beijing

ZIP/Postal Code

100730

Country

China

City

Chengdu

ZIP/Postal Code

610041

Country

China

City

Guangzhou

ZIP/Postal Code

510080

Country

China

City

Guangzhou

ZIP/Postal Code

510120

Country

China

City

Guangzhou

ZIP/Postal Code

510515

Country

China

City

Hangzhou

ZIP/Postal Code

310003

Country

China

City

Nanjing

ZIP/Postal Code

210008

Country

China

City

Nanjing

ZIP/Postal Code

210029

Country

China

City

Shanghai

ZIP/Postal Code

2000092

Country

China

City

Shanghai

ZIP/Postal Code

200040

Country

China

City

Shanghai

ZIP/Postal Code

200120

Country

China

City

Shanghai

ZIP/Postal Code

200433

Country

China

City

Shenyang

ZIP/Postal Code

110001

Country

China

City

Tianjin

ZIP/Postal Code

300070

Country

China

City

Wuhan

ZIP/Postal Code

430030

Country

China

City

Xian

ZIP/Postal Code

710061

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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