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

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes
• Interventions: Other: No treatment given

• Registration Number: NCT01351922
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-05-10
• Study First Submitted QC: 2011-05-10
• Study First Posted: 2011-05-11
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12000

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	No treatment given	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇮🇳 Bangalore, India