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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
ClinicalTrials.gov Identifier:
NCT00788853
First received: November 10, 2008
Last updated: July 13, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
 Other: No treatment given

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Blood sample


Enrollment: 1825
Study Start Date: November 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Other: No treatment given
No treatment is given

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00788853

Locations
Indonesia
Jakarta, Indonesia, 12520
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Ashok Kumar Moharana, MD Novo Nordisk India Private Ltd
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00788853     History of Changes
Other Study ID Numbers: INS-3677
Study First Received: November 10, 2008
Last Updated: July 13, 2012
Health Authority: Indonesia: National Agency of Drug and Food Control

Keywords provided by Novo Nordisk:
DiabCare Asia 2008, Cross-sectional survey, Glycemic control, Psychosocial well-being, Diabetic complications, Quality of life.

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013