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Diabetes Mellitus Type 2NCT01130480

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

A study testing Accu-Chek Integra Glucometer in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 19 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages Up to 70 years
Conditions the study is for
Diabetes Mellitus Type 2
What is being tested?
Accu-Chek Integra Glucometer
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
833 participants
Where
19 sitesChina
Study dates
31 May 2010to 31 Mar 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Patients unable or unwilling to comply with the requirements of the protocol

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

China19 sites

  • Study site

    Beijing, 100020

  • Study site

    Beijing, 100034

  • Study site

    Beijing, 100044

  • Study site

    Beijing, 100730

  • Study site

    Chengdu, 610041

  • Study site

    Guangzhou, 510080

  • Study site

    Guangzhou, 510120

  • Study site

    Guangzhou, 510515

  • Study site

    Hangzhou, 310003

  • Study site

    Nanjing, 210008

  • Study site

    Nanjing, 210029

  • Study site

    Shanghai, 2000092

  • Study site

    Shanghai, 200040

  • Study site

    Shanghai, 200120

  • Study site

    Shanghai, 200433

  • Study site

    Shenyang, 110001

  • Study site

    Tianjin, 300070

  • Study site

    Wuhan, 430030

  • Study site

    Xi'an, 710061

Other trials in China

About this 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.

Being tested
Accu-Chek Integra Glucometer
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Accu-Chek Integra GlucometerDevice

Study groups in NCT01130480
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Device: Accu-Chek Integra Glucometer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c change between the baseline and end of study

    Measured: From baseline to month 6

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

    Measured: From baseline to month 6

Secondary outcomes (3)

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

    Measured: From baseline to month 6

  2. Relationship between SMBG frequency change and blood glucose control

    Measured: From baseline to month 6

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

    Measured: From baseline to month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2010 (estimated)
  2. Study start31 May 2010
  3. Primary completion31 Mar 2012
  4. Study completion31 Mar 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
833 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01130480
Sponsor's protocol ID
RD000933
Status last verified
Apr 2017
First submitted
19 May 2010
Last updated
4 Apr 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Accu-Chek Integra Glucometer in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 19 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c change between the baseline and end of study (time frame: From baseline to month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01130480.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.

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