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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00839878
First received: February 6, 2009
Last updated: July 17, 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.


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: 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 (Bangladesh)

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 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 eye complications [ 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 ]

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 and 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: 2092
Study Start Date: March 2009
Study Completion Date: March 2009
Primary Completion Date: March 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 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839878

Locations
Bangladesh
Dhaka, Bangladesh, 1206
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Mohammad Mahbubur Rahman, MBBS Novo Nordisk Pharma Private Limited.
  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: NCT00839878     History of Changes
Other Study ID Numbers: INS-3738
Study First Received: February 6, 2009
Last Updated: July 17, 2012
Health Authority: Bangladesh: Drug Control Administration

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 June 17, 2013