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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00918151
Recruitment Status : Completed
First Posted : June 11, 2009
Last Update Posted : August 13, 2014
Information provided by (Responsible Party):
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, and complications in diabetic subjects in Asia.

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

Study Type : Observational
Actual Enrollment : 1932 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: DiabCare Asia 2008 (Korea): A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Diabetic Patients in Asia & To Evaluate Perceptions and Practices of Physicians & Patients About Diabetes Management in Asia
Study Start Date : May 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
A Other: No treatment given
Subject will only fill out a questionaire when entering the observational study

Primary Outcome Measures :
  1. Mean age of onset of type 1 and type 2 diabetes mellitus, respectively [ Time Frame: at baseline visit/study start ]
  2. Mean duration of treatment of type 2 diabetes mellitus. [ Time Frame: at baseline visit/study start ]
  3. Percentage of patients on insulin and Oral Anti-Diabetics Drugs (OADs) therapy, respectively [ Time Frame: at baseline visit/study start ]
  4. Mean duration of diabetes in type 1 and type 2 diabetic patients respectively [ Time Frame: at baseline visit/study start ]
  5. Mean FPG (fasting plasma glucose),PPG (post prandial glucose) and HbA1c of diabetic patients. [ Time Frame: at baseline visit/study start ]
  6. Percentage of diabetic patients with HbA1c target below 7.0% and below 6.5%, respectively [ Time Frame: at baseline visit/study start ]
  7. Percentage of diabetic patients having dyslipidemia and hypertension, cardiovascular complications, peripheral vascular disease, diabetic nephropathy and diabetic eye complications, respectively [ Time Frame: at baseline visit/study start ]

Secondary Outcome Measures :
  1. Patients' perception will be analysed through patient questionnaire measuring psychological well-being, quality of life and patients' compliant to treatment [ Time Frame: at baseline visit/study start ]
  2. 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 ]
  3. Duration of diabetes associated with highest number of diabetic complications [ Time Frame: at baseline visit/study start ]
  4. Minimum duration of diabetes associated with 10% incidence of diabetic complications (CVD, nephropathy and retinopathy) [ Time Frame: at baseline visit/study start ]

Biospecimen Retention:   Samples With DNA
Capillary or venous blood will be drawn for analysing HbA1c

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00918151

Korea, Republic of
Seoul, Korea, Republic of, 137-920
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452), Project Manager Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT00918151     History of Changes
Other Study ID Numbers: INS-3781
First Posted: June 11, 2009    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014

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