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

NCT00839878 | Completed

• 1 other identifier: INS-3738
• Study Type: observational
• Target: 2,092
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (13)

• Mean age of onset of type 1 and 2 diabetes mellitus

  at baseline visit/study start

• Mean duration of treatment of type 2 DM

  at baseline visit/study start

• Percentage of patients on Insulin and OAD therapy

  at baseline visit/study start

• Mean duration of diabetes in type 1 and type 2 patients respectively

  at baseline visit/study start

• Mean FPG and PPG of diabetic patients

  at baseline visit/study start

• Mean HbA1c of diabetic patients

  at baseline visit/study start

• Percentage of diabetic patients with HbA1c target below or equal to 7.0%.

  at baseline visit/study start

• Percentage of diabetic patients with HbA1c target below or equal to 6.5%.

  at baseline visit/study start

• Percentage of diabetic patients having dyslipidemia and hypertension

  at baseline visit/study start

• Percentage of diabetic patients having cardiovascular complications

  at baseline visit/study start

• Percentage of diabetic patients having peripheral vascular disease

  at baseline visit/study start

• Percentage of diabetic patients having diabetic eye complications

  at baseline visit/study start

• Percentage of diabetic patients having diabetic nephropathy

  at baseline visit/study start

Secondary Outcomes (4)

• Patients' perception will be analysed through Patient questionnaire measuring:Psychological well-being, Quality of life and Patients' compliant to treatment

  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

  at baseline visit/study start

• Duration of diabetes associated with highest number of diabetic complications

  at baseline visit/study start

• Minimum duration of diabetes associated with 10% incidence of diabetic complications (CVD, nephropathy and retinopathy)

  at baseline visit/study start

Study Arms (1)

A

Other: No treatment given

Interventions

No treatment given OTHER

Subject will only fill out a questionaire when entering the observational study.

A

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Repetition of any patient as patients should not be included twice for any reason.
• Unwilling to participate or unable to comply with protocol requirements.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Dhaka, 1206, Bangladesh

Location

Related Links

• Clinical Trials at Novo Nordisk

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: February 10, 2009
• Study Start: March 1, 2009
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: October 14, 2016

Record last verified: 2016-10

Locations

BA (1)