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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

February 6, 2009
July 17, 2012
March 2009
March 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00839878 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Diabetic Subjects in Bangladesh
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)

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.
Not Provided
Observational
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

Blood sample
Non-Probability Sample

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.
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
Other: No treatment given
Subject will only fill out a questionaire when entering the observational study.
A
Intervention: Other: No treatment given
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2092
March 2009
March 2009   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Bangladesh
 
NCT00839878
INS-3738
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
Not Provided
Study Director: Mohammad Mahbubur Rahman, MBBS Novo Nordisk Pharma Private Limited.
Novo Nordisk
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP