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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:
ClinicalTrials.gov Identifier:
NCT01351922
First Posted: May 11, 2011
Last Update Posted: January 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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:


Further study details as provided by Novo Nordisk A/S:

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01351922


Locations
India
Novo Nordisk Investigational Site
Bangalore, India, 560001
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01351922     History of Changes
Other Study ID Numbers: INS-3933
U1111-1120-5710 ( Other Identifier: WHO )
First Submitted: May 10, 2011
First Posted: May 11, 2011
Last Update Posted: January 19, 2017
Last Verified: January 2017

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


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