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

January 18, 2017 updated by: Novo Nordisk A/S

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

12000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Bangalore, India, 560001
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Other: No treatment given
Patients will fill out a questionaire by interview.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean age of onset of type 1 diabetes mellitus
Time Frame: Evaluation visit
Evaluation visit
Mean age of onset of type 2 diabetes mellitus
Time Frame: Evaluation visit
Evaluation visit
Mean duration of treatment of type 2 diabetes mellitus
Time Frame: Evaluation visit
Evaluation visit
Percentage of patients on Insulin therapy
Time Frame: Evaluation visit
Evaluation visit
Percentage of patients on Oral Anti-Diabetics Drug (OADs) therapy
Time Frame: Evaluation visit
Evaluation visit
Mean duration of diabetes in type 1 patients
Time Frame: Evaluation visit
Evaluation visit
Mean duration of diabetes in type 2 patients
Time Frame: Evaluation visit
Evaluation visit
Mean FPG (fasting plasma glucose)
Time Frame: Evaluation visit
Evaluation visit
PPG (post prandial glucose)
Time Frame: Evaluation visit
Evaluation visit
HbA1c (Glycosylated Haemoglobin)
Time Frame: Evaluation visit
Evaluation visit
Percentage of patients archiving HbA1c target below or equal 6.5%
Time Frame: Evaluation visit
Evaluation visit
Percentage of patients archiving HbA1c target below or equal 7.0%
Time Frame: Evaluation visit
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
Evaluation visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

May 10, 2011

First Submitted That Met QC Criteria

May 10, 2011

First Posted (Estimate)

May 11, 2011

Study Record Updates

Last Update Posted (Estimate)

January 19, 2017

Last Update Submitted That Met QC Criteria

January 18, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INS-3933
  • U1111-1120-5710 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on No treatment given

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe