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NCT Number: NCT01351922

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

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.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Bangalore, 560001, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No treatment given

Other

Patients will fill out a questionaire by interview.

Primary outcomes

  1. Mean age of onset of type 1 diabetes mellitus

    Time frame: Evaluation visit

  2. Mean age of onset of type 2 diabetes mellitus

    Time frame: Evaluation visit

  3. Mean duration of treatment of type 2 diabetes mellitus

    Time frame: Evaluation visit

  4. Percentage of patients on Insulin therapy

    Time frame: Evaluation visit

  5. Percentage of patients on Oral Anti-Diabetics Drug (OADs) therapy

    Time frame: Evaluation visit

  6. Mean duration of diabetes in type 1 patients

    Time frame: Evaluation visit

  7. Mean duration of diabetes in type 2 patients

    Time frame: Evaluation visit

  8. Mean FPG (fasting plasma glucose)

    Time frame: Evaluation visit

  9. PPG (post prandial glucose)

    Time frame: Evaluation visit

  10. HbA1c (Glycosylated Haemoglobin)

    Time frame: Evaluation visit

  11. Percentage of patients archiving HbA1c target below or equal 6.5%

    Time frame: Evaluation visit

  12. Percentage of patients archiving HbA1c target below or equal 7.0%

    Time frame: Evaluation visit

  13. Percentage of patients having complications (dyslipidemia and hypertension, cardiovascular complications, peripheral vascular disease, diabetic nephropathy and diabetic eye complications)

    Time frame: Evaluation visit

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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)

Acronym: DiabCare India

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 11, 2011
Registry last updated
Jan 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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