- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00877526
A Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Diabetic Subjects in Malaysia (DiabCare Asia)
November 21, 2016 updated by: Novo Nordisk A/S
DiabCare Asia 2008 (Malaysia): A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Diabetic Patients in Asia & To Evaluate Perceptions and Practices of Physicians & Patients About Diabetes Management in Asia
This study is conducted in Asia.
The aim of this observational study is to evaluate current status of diabetes management, control, and complications in diabetic subjects in Asia.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1670
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Selangor Darul Ehsan, Malaysia
- Novo Nordisk Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with diabetes mellitus (both type 1 and type 2) being treated at general hospitals, diabetes clinics and referral clinics will be selected according to the inclusion and exclusion criteria.
Description
Inclusion Criteria:
- Diabetic patients registered in the particular centre for more than 12 months.
- Patients should have visited the centre at least once in the last 3-6 months apart from the initial visit.
- Patients willing to sign informed consent form.
Exclusion Criteria:
- Repetition of any patient as patients should not be included twice for any reason.
- Unwilling to participate or unable to comply with protocol requirements.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
A
|
Subject will only fill out a questionaire when entering the observational study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean age of onset of type 1 and type 2 diabetes mellitus, respectively
Time Frame: at baseline visit/study start
|
at baseline visit/study start
|
Mean duration of treatment of type 2 Diabetes mellitus
Time Frame: at baseline visit/study start
|
at baseline visit/study start
|
Percentage of patients on insulin and Oral Anti-Diabetics Drugs (OADs) theraphy, respectively
Time Frame: at baseline visit/study start
|
at baseline visit/study start
|
Mean duration of diabetes in type 1 and type 2 diabetic patients respectively
Time Frame: at baseline visit/study start
|
at baseline visit/study start
|
Mean FPG (Fasting plasma glucose), PPG (Post prandial glucose) and HbA1c of diabetic patients
Time Frame: at baseline visit/study start
|
at baseline visit/study start
|
Percentage of diabetic patients with HbA1c target below 7.0% and below 6.5%, respectively
Time Frame: at baseline visit/study start
|
at baseline visit/study start
|
Percentage of diabetic patients having dyslipidemia and hypertension, cardiovascular complications, peripheral vascular disease, diabetic nephropathy and diabetic eye complications, respectively
Time Frame: at baseline visit/study start
|
at baseline visit/study start
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patients' perception will be analysed through patient questionnaire measuring: Psychological well-being, Quality of Life and patients' compliant to treatmen
Time Frame: at baseline visit/study start
|
at baseline visit/study start
|
Physician perception of diabetes and its management will be analysed through physician questionnaire measuring awareness about: HbA1c test and its goal, anti-diabetic treatment, barriers towards optimum diabetes control
Time Frame: at baseline visit/study start
|
at baseline visit/study start
|
Duration of diabetes associated with highest number of diabetic complications
Time Frame: at baseline visit/study start
|
at baseline visit/study start
|
Minimum duration of diabetes associated with 10% incidence of diabetic complications (CVD, Nephropathy and retinopathy)
Time Frame: at baseline visit/study start
|
at baseline visit/study start
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
April 6, 2009
First Submitted That Met QC Criteria
April 6, 2009
First Posted (Estimate)
April 7, 2009
Study Record Updates
Last Update Posted (Estimate)
November 22, 2016
Last Update Submitted That Met QC Criteria
November 21, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INS-3723
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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