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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00788853
First received: November 10, 2008
Last updated: July 13, 2012
Last verified: July 2012

November 10, 2008
July 13, 2012
November 2008
February 2010   (final data collection date for primary outcome measure)
  • Mean age of onset of either type 1 or type 2 diabetes mellitus [ Time Frame: study visit ] [ Designated as safety issue: No ]
  • Mean duration of treatment of type 2 diabetes mellitus. [ Time Frame: study visit ] [ Designated as safety issue: No ]
  • Percentage of patients on either insulin therapy or OAD (oral anti-diabetic drug) therapy. [ Time Frame: study visit ] [ Designated as safety issue: No ]
  • Mean duration of diabetes in type 1 and type 2 diabetes patients respectively. [ Time Frame: study visit ] [ Designated as safety issue: No ]
  • Mean FPG (fasting plasma glucose),PPG (post prandial glucose) and HbA1c of diabetic patients. [ Time Frame: study visit ] [ Designated as safety issue: No ]
  • Percentage of diabetic patients with HbA1c target below or equal to 7.0%. [ Time Frame: study visit ] [ Designated as safety issue: No ]
  • Percentage of diabetic patients with HbA1c target below or equal to 6.5%. [ Time Frame: study visit ] [ Designated as safety issue: No ]
  • Percentage of diabetic patients having dyslipidemia and hypertension [ Time Frame: study visit ] [ Designated as safety issue: No ]
  • Percentage of diabetic patients having cardiovascular complications [ Time Frame: study visit ] [ Designated as safety issue: No ]
  • Percentage of diabetic patients having peripheral vascular disease [ Time Frame: study visit ] [ Designated as safety issue: No ]
  • Percentage of diabetic patients having diabetic nephropathy [ Time Frame: study visit ] [ Designated as safety issue: No ]
  • Percentage of diabetic patients having diabetic eye complications [ Time Frame: study visit ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00788853 on ClinicalTrials.gov Archive Site
  • Patients' perception will be analysed through Patient questionnaire measuring:Psychological well-being, Quality of life and Patients' compliant to treatment [ Time Frame: study visit ] [ Designated as safety issue: No ]
  • Physician questionnaire measuring awareness about:HbA1c test and its goal, Anti-diabetic treatment and Barriers towards optimum diabetes control [ Time Frame: study visit ] [ Designated as safety issue: No ]
  • Duration of diabetes associated with highest number of diabetic complications [ Time Frame: study visit ] [ Designated as safety issue: No ]
  • Minimum duration of diabetes associated with 10% incidence of diabetic complications (CVD, nephropathy and retinopathy) [ Time Frame: study visit ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Diabetic Subjects in Indonesia
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

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.

Not Provided
Observational
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

Blood sample

Non-Probability Sample

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.

  • Diabetes
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
Other: No treatment given
No treatment is given
A
Intervention: Other: No treatment given
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1825
February 2010
February 2010   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Indonesia
 
NCT00788853
INS-3677
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Ashok Kumar Moharana, MD Novo Nordisk India Private Ltd
Novo Nordisk A/S
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP