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Trial record 17 of 7531 for:    diabetes
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A Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Diabetic Subjects in India (DiabCare India)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01351922
First received: May 10, 2011
Last updated: November 1, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


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 India and to Evaluate Perceptions and Practices of Physicians and Patients About Diabetes Management in India (DiabCare India 2011)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Mean age of onset of type 1 diabetes mellitus [ Time Frame: Evaluation visit ] [ Designated as safety issue: No ]
  • Mean age of onset of type 2 diabetes mellitus [ Time Frame: Evaluation visit ] [ Designated as safety issue: No ]
  • Mean duration of treatment of type 2 diabetes mellitus [ Time Frame: Evaluation visit ] [ Designated as safety issue: No ]
  • Percentage of patients on Insulin therapy [ Time Frame: Evaluation visit ] [ Designated as safety issue: No ]
  • Percentage of patients on Oral Anti-Diabetics Drug (OADs) therapy [ Time Frame: Evaluation visit ] [ Designated as safety issue: No ]
  • Mean duration of diabetes in type 1 patients [ Time Frame: Evaluation visit ] [ Designated as safety issue: No ]
  • Mean duration of diabetes in type 2 patients [ Time Frame: Evaluation visit ] [ Designated as safety issue: No ]
  • Mean FPG (fasting plasma glucose) [ Time Frame: Evaluation visit ] [ Designated as safety issue: No ]
  • PPG (post prandial glucose) [ Time Frame: Evaluation visit ] [ Designated as safety issue: No ]
  • HbA1c (Glycosylated Haemoglobin) [ Time Frame: Evaluation visit ] [ Designated as safety issue: No ]
  • Percentage of patients archiving HbA1c target below or equal 6.5% [ Time Frame: Evaluation visit ] [ Designated as safety issue: No ]
  • Percentage of patients archiving HbA1c target below or equal 7.0% [ Time Frame: Evaluation visit ] [ Designated as safety issue: No ]
  • Percentage of patients having complications (dyslipidemia and hypertension, cardiovascular complications, peripheral vascular disease, diabetic nephropathy and diabetic eye complications) [ Time Frame: Evaluation visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 12000
Study Start Date: April 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Other: No treatment given
Patients will fill out a questionaire by interview.

  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351922

Locations
India
Bangalore, India, 560001
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Shahid Akhtar Novo Nordisk India Private Ltd.
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT01351922     History of Changes
Other Study ID Numbers: INS-3933, U1111-1120-5710
Study First Received: May 10, 2011
Last Updated: November 1, 2011
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013