A Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Diabetic Subjects in Indonesia

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
• Interventions: Other: No treatment given

• Registration Number: NCT00788853
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-10
• Study First Submitted QC: 2008-11-10
• Study First Posted: 2008-11-11
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-23
• Last Update Posted: 2014-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1832

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	No treatment given	-

Primary Outcome Measures

Name	Time	Method
Mean age of onset of either type 1 or type 2 diabetes mellitus	study visit
Percentage of diabetic patients having diabetic nephropathy	study visit
Percentage of diabetic patients having cardiovascular complications	study visit
Mean duration of treatment of type 2 diabetes mellitus.	study visit
Mean duration of diabetes in type 1 and type 2 diabetes patients respectively.	study visit
Percentage of diabetic patients with HbA1c target below or equal to 6.5%.	study visit
Percentage of diabetic patients with HbA1c target below or equal to 7.0%.	study visit
Percentage of patients on either insulin therapy or OAD (oral anti-diabetic drug) therapy.	study visit
Percentage of diabetic patients having peripheral vascular disease	study visit
Percentage of diabetic patients having diabetic eye complications	study visit
Mean FPG (fasting plasma glucose),PPG (post prandial glucose) and HbA1c of diabetic patients.	study visit
Percentage of diabetic patients having dyslipidemia and hypertension	study visit

Secondary Outcome Measures

Name	Time	Method
Patients' perception will be analysed through Patient questionnaire measuring:Psychological well-being, Quality of life and Patients' compliant to treatment	study visit
Duration of diabetes associated with highest number of diabetic complications	study visit
Physician questionnaire measuring awareness about:HbA1c test and its goal, Anti-diabetic treatment and Barriers towards optimum diabetes control	study visit
Minimum duration of diabetes associated with 10% incidence of diabetic complications (CVD, nephropathy and retinopathy)	study visit