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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00918151
First received: June 9, 2009
Last updated: August 12, 2014
Last verified: August 2014
  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 (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

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 type 2 diabetes mellitus, respectively [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]
  • Mean duration of treatment of type 2 diabetes mellitus. [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]
  • Percentage of patients on insulin and Oral Anti-Diabetics Drugs (OADs) therapy, respectively [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]
  • Mean duration of diabetes in type 1 and type 2 diabetic patients respectively [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]
  • Mean FPG (fasting plasma glucose),PPG (post prandial glucose) and HbA1c of diabetic patients. [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]
  • Percentage of diabetic patients with HbA1c target below 7.0% and below 6.5%, respectively [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]
  • 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 ] [ 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: 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

Capillary or venous blood will be drawn for analysing HbA1c


Enrollment: 1932
Study Start Date: May 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Other: No treatment given
Subject will only fill out a questionaire when entering the observational study

  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: NCT00918151

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

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00918151     History of Changes
Other Study ID Numbers: INS-3781
Study First Received: June 9, 2009
Last Updated: August 12, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on November 20, 2014