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

Diabetes Mellitus, Type 2 Clinical Trial

— DiabCare India  

Official title:

A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Diabetic Patients in India and to Evaluate Perceptions and Practices of Physicians and Patients About Diabetes Management in India (DiabCare India 2011)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01351922
• Other study ID #: INS-3933
• Secondary ID: U1111-1120-5710
• Status: Completed
• Phase: N/A
• First received: May 10, 2011
• Last updated: January 18, 2017
• Start date: April 2011
• Est. completion date: September 2011

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is conducted in Asia. The aim of this observational study is to evaluate the current status of diabetes management, control, and complications in diabetic subjects in India. Perceptions and practices of physicians and subjects about diabetes management will also be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12000
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients should have visited the centre at least once in the last 3-6 months apart from the initial visit

• First twenty patients of diabetes visiting the centre during the data collection period

• Patients willing to sign the 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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

Other:
• No treatment given
Patients will fill out a questionaire by interview.

Locations

Country	Name	City	State
India	Novo Nordisk Investigational Site	Bangalore

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

India, 

References & Publications (1)

Mohan V, Shah SN, Joshi SR, Seshiah V, Sahay BK, Banerjee S, Wangnoo SK, Kumar A, Kalra S, Unnikrishnan AG, Sharma SK, Rao PV, Akhtar S, Shetty RV, Das AK; DiabCare India 2011 Study Group.. Current status of management, control, complications and psychoso — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean age of onset of type 1 diabetes mellitus		Evaluation visit
Primary	Mean age of onset of type 2 diabetes mellitus		Evaluation visit
Primary	Mean duration of treatment of type 2 diabetes mellitus		Evaluation visit
Primary	Percentage of patients on Insulin therapy		Evaluation visit
Primary	Percentage of patients on Oral Anti-Diabetics Drug (OADs) therapy		Evaluation visit
Primary	Mean duration of diabetes in type 1 patients		Evaluation visit
Primary	Mean duration of diabetes in type 2 patients		Evaluation visit
Primary	Mean FPG (fasting plasma glucose)		Evaluation visit
Primary	PPG (post prandial glucose)		Evaluation visit
Primary	HbA1c (Glycosylated Haemoglobin)		Evaluation visit
Primary	Percentage of patients archiving HbA1c target below or equal 6.5%		Evaluation visit
Primary	Percentage of patients archiving HbA1c target below or equal 7.0%		Evaluation visit
Primary	Percentage of patients having complications (dyslipidemia and hypertension, cardiovascular complications, peripheral vascular disease, diabetic nephropathy and diabetic eye complications)		Evaluation visit

External Links

•   Clinical Trials at Novo Nordisk