Clinical trial NCT00839878: A Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Diabetic Subjects in Bangladesh
Official title: 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 (Bangladesh)
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: 2009-02-10
Enrollment: 2092
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.


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 2 diabetes mellitus
timeFrame: at baseline visit/study start
measure: Mean duration of treatment of type 2 DM
timeFrame: at baseline visit/study start
measure: Percentage of patients on Insulin and OAD therapy
timeFrame: at baseline visit/study start
measure: Mean duration of diabetes in type 1 and type 2 patients respectively
timeFrame: at baseline visit/study start
measure: Mean FPG and PPG of diabetic patients
timeFrame: at baseline visit/study start
measure: Mean HbA1c of diabetic patients
timeFrame: at baseline visit/study start
measure: Percentage of diabetic patients with HbA1c target below or equal to 7.0%.
timeFrame: at baseline visit/study start
measure: Percentage of diabetic patients with HbA1c target below or equal to 6.5%.
timeFrame: at baseline visit/study start
measure: Percentage of diabetic patients having dyslipidemia and hypertension
timeFrame: at baseline visit/study start
measure: Percentage of diabetic patients having cardiovascular complications
timeFrame: at baseline visit/study start
measure: Percentage of diabetic patients having peripheral vascular disease
timeFrame: at baseline visit/study start
measure: Percentage of diabetic patients having diabetic eye complications
timeFrame: at baseline visit/study start
measure: Percentage of diabetic patients having diabetic nephropathy
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 treatment
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 and 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: Dhaka
country: Bangladesh
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: