Clinical trial NCT00877526: A Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Diabetic Subjects in Malaysia
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-04-07
Enrollment: 1670
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean age of onset of type 1 and type 2 diabetes mellitus, respectively
timeFrame: at baseline visit/study start
measure: Mean duration of treatment of type 2 Diabetes mellitus
timeFrame: at baseline visit/study start
measure: Percentage of patients on insulin and Oral Anti-Diabetics Drugs (OADs) theraphy, respectively
timeFrame: at baseline visit/study start
measure: Mean duration of diabetes in type 1 and type 2 diabetic patients respectively
timeFrame: at baseline visit/study start
measure: Mean FPG (Fasting plasma glucose), PPG (Post prandial glucose) and HbA1c of diabetic patients
timeFrame: at baseline visit/study start
measure: Percentage of diabetic patients with HbA1c target below 7.0% and below 6.5%, respectively
timeFrame: at baseline visit/study start
measure: Percentage of diabetic patients having dyslipidemia and hypertension, cardiovascular complications, peripheral vascular disease, diabetic nephropathy and diabetic eye complications, respectively
timeFrame: at baseline visit/study start
Secondary outcomes:
measure: Patients' perception will be analysed through patient questionnaire measuring: Psychological well-being, Quality of Life and patients' compliant to treatmen
timeFrame: at baseline visit/study start
measure: 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
timeFrame: at baseline visit/study start
measure: Duration of diabetes associated with highest number of diabetic complications
timeFrame: at baseline visit/study start
measure: Minimum duration of diabetes associated with 10% incidence of diabetic complications (CVD, Nephropathy and retinopathy)
timeFrame: at baseline visit/study start
Other outcomes:
Locations:
city: Selangor Darul Ehsan
country: Malaysia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: