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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00836030
First received: January 30, 2009
Last updated: July 16, 2012
Last verified: July 2012
  Purpose

This study is conducted in Asia. The aim of this observational study is to evaluate current status of diabetes management, control and complications in diabetic subjects in Asia.


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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Mean age of onset of type 1 and 2 diabetes mellitus [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]
  • Mean duration of treatment of type 2 DM [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]
  • Percentage of patients on Insulin and OAD therapy [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]
  • Mean duration of diabetes in type 1 and type 2 patients respectively [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]
  • Mean FPG and PPG of diabetic patients [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]
  • Mean HbA1c of diabetic patients [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]
  • Percentage of diabetic patients with HbA1c target below or equal to 7.0% [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]
  • Percentage of diabetic patients with HbA1c target below or equal to 6.5% [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]
  • Percentage of diabetic patients having dyslipidemia and hypertension [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]
  • Percentage of diabetic patients having cardiovascular complications [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]
  • Percentage of diabetic patients having peripheral vascular disease [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]
  • Percentage of diabetic patients having diabetic nephropathy [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]
  • Percentage of diabetic patients having diabetic eye complications [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patients' perception will be analysed through Patient questionnaire measuring - Psychological well-being, Quality of life, Patients' compliant to treatment [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]
  • Physician perception of diabetes and its management will be analysed through Physician questionnaire measuring awareness about - HbA1c test and its goal, Anti-diabetic treatment, Barriers towards optimum diabetes control [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]
  • Duration of diabetes associated with highest number of diabetic complications [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]
  • Minimum duration of diabetes associated with 10% incidence of diabetic complications (CVD, Nephropathy and retinopathy) [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood sample


Enrollment: 854
Study Start Date: January 2009
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Other: No treatment given
No treatment 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 the inclusion and exclusion criteria.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00836030

Locations
Singapore
Singapore, Singapore, 307684
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: ASLENA BINTE HUSSAIN, Bsc Novo Nordisk Pharma (Singapore) Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00836030     History of Changes
Other Study ID Numbers: INS-3710
Study First Received: January 30, 2009
Last Updated: July 16, 2012
Health Authority: Singapore: Health Sciences Authority

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 August 28, 2014