Clinical trial NCT00788853: A Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Diabetic Subjects in Indonesia
Official title: DiabCare Asia 2008. A Cross-sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Diabetic Patients in Asia and to Evaluate Perceptions and Practices of Physicians and Patients About Diabetes Management in Asia. DiabCare Asia 2008 - Indonesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Keywords: DiabCare Asia 2008, Cross-sectional survey, Glycemic control, Psychosocial well-being, Diabetic complications, Quality of life.
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-11-11
Enrollment: 1832
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 inclusion and exclusion criteria. Patients will be selected randomly from clinic record/list to avoid any bias.

Brief summary: This study is conducted in Asia. The aim of this observational study is to evaluate current status of diabetes management, control, complications in diabetic subjects in Asia. Further perceptions and practices of physicians and subjects about diabetes management in Asia will be evaluated.


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 before the initial study 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 either type 1 or type 2 diabetes mellitus
timeFrame: study visit
measure: Mean duration of treatment of type 2 diabetes mellitus.
timeFrame: study visit
measure: Percentage of patients on either insulin therapy or OAD (oral anti-diabetic drug) therapy.
timeFrame: study visit
measure: Mean duration of diabetes in type 1 and type 2 diabetes patients respectively.
timeFrame: study visit
measure: Mean FPG (fasting plasma glucose),PPG (post prandial glucose) and HbA1c of diabetic patients.
timeFrame: study visit
measure: Percentage of diabetic patients with HbA1c target below or equal to 7.0%.
timeFrame: study visit
measure: Percentage of diabetic patients with HbA1c target below or equal to 6.5%.
timeFrame: study visit
measure: Percentage of diabetic patients having dyslipidemia and hypertension
timeFrame: study visit
measure: Percentage of diabetic patients having cardiovascular complications
timeFrame: study visit
measure: Percentage of diabetic patients having peripheral vascular disease
timeFrame: study visit
measure: Percentage of diabetic patients having diabetic nephropathy
timeFrame: study visit
measure: Percentage of diabetic patients having diabetic eye complications
timeFrame: study visit
Secondary outcomes:
measure: Patients' perception will be analysed through Patient questionnaire measuring:Psychological well-being, Quality of life and Patients' compliant to treatment
timeFrame: study visit
measure: Physician questionnaire measuring awareness about:HbA1c test and its goal, Anti-diabetic treatment and Barriers towards optimum diabetes control
timeFrame: study visit
measure: Duration of diabetes associated with highest number of diabetic complications
timeFrame: study visit
measure: Minimum duration of diabetes associated with 10% incidence of diabetic complications (CVD, nephropathy and retinopathy)
timeFrame: study visit
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: