We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00839878
First Posted: February 10, 2009
Last Update Posted: October 14, 2016
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.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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:


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 ]
  • Mean duration of treatment of type 2 DM [ Time Frame: at baseline visit/study start ]
  • Percentage of patients on Insulin and OAD therapy [ Time Frame: at baseline visit/study start ]
  • Mean duration of diabetes in type 1 and type 2 patients respectively [ Time Frame: at baseline visit/study start ]
  • Mean FPG and PPG of diabetic patients [ Time Frame: at baseline visit/study start ]
  • Mean HbA1c of diabetic patients [ Time Frame: at baseline visit/study start ]
  • Percentage of diabetic patients with HbA1c target below or equal to 7.0%. [ Time Frame: at baseline visit/study start ]
  • Percentage of diabetic patients with HbA1c target below or equal to 6.5%. [ Time Frame: at baseline visit/study start ]
  • Percentage of diabetic patients having dyslipidemia and hypertension [ Time Frame: at baseline visit/study start ]
  • Percentage of diabetic patients having cardiovascular complications [ Time Frame: at baseline visit/study start ]
  • Percentage of diabetic patients having peripheral vascular disease [ Time Frame: at baseline visit/study start ]
  • Percentage of diabetic patients having diabetic eye complications [ Time Frame: at baseline visit/study start ]
  • Percentage of diabetic patients having diabetic nephropathy [ Time Frame: at baseline visit/study start ]

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 ]
  • 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 ]
  • Duration of diabetes associated with highest number of diabetic complications [ Time Frame: at baseline visit/study start ]
  • 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
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

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, Senior
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 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
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 ClinicalTrials.gov identifier (NCT number): NCT00839878


Locations
Bangladesh
Novo Nordisk Investigational Site
Dhaka, Bangladesh, 1206
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00839878     History of Changes
Other Study ID Numbers: INS-3738
First Submitted: February 6, 2009
First Posted: February 10, 2009
Last Update Posted: October 14, 2016
Last Verified: October 2016

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