Clinical trial NCT00874159: A Survey to Evaluate Diabetes Management, Control, Complications and Psychosocial Aspects of Diabetic Patients in Philippines
Official title: DiabCare Asia 2008 Philippines A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Diabetic Patients in Philippines & To Evaluate Perceptions and Practices of Physicians & Patients About Diabetes Management in Philippines
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: 2009-04-02
Enrollment: 770
Sex: ALL
Minimum age (years): 18
Standard ages: 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.

Brief summary: This study is conducted in Asia. The aim of this observational study is to describe the diabetes management, control status and complication profile in a diabetic population of Philippines.


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 diabetes mellitus
timeFrame: at baseline visit/study start
measure: Mean age of onset of type 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 therapy
timeFrame: at baseline visit/study start
measure: Percentage of patients on 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 of diabetic patients
timeFrame: at baseline visit/study start
measure: Mean 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 7.0%
timeFrame: at baseline visit/study start
measure: Percentage of diabetic patients with HbA1c target below 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 nephropathy
timeFrame: at baseline visit/study start
measure: Percentage of diabetic patients having diabetic eye complications
timeFrame: at baseline visit/study start
Secondary outcomes:
measure: Patients' perception will be analysed through Patient questionnaire measuring: Psychological well-being, Quality of life, 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:o 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: Manilla
country: Philippines
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: