Changing Diabetes in Children (CDiC)

March 3, 2015 updated by: Novo Nordisk A/S

Changing Diabetes in Children (CDiC): Type 1 Diabetes in Economically Underprivileged Children in India

This study is conducted in Asia. The primary objective of the CDiC programme is to improve access to comprehensive diabetes care among the children with diabetes from the economically underprivileged section of the population and to establish a registry for this group of children with type 1 diabetes in India.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3089

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

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

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children with type 1 diabetes aged below 18 years will be included.

Description

Inclusion Criteria:

  • Children diagnosed with type 1 diabetes
  • Parents/caretakers agree to participate in the study
  • Child belongs to the below poverty line economic strata (Centre Director certifies economic status for inclusion in to the study)

Exclusion Criteria:

  • Children with type 2 diabetes
  • Children from higher economic status
  • Those getting coverage under other government / private schemes

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
Children
Drug: insulin human
Children will receive conventional treatment with human insulin according to standard medical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient assessments: Number of days on insulin
Time Frame: After 40 months
After 40 months
Number of days with home blood glucose monitoring
Time Frame: After 40 months
After 40 months
HbA1c (glycosylated haemoglobin)
Time Frame: After 40 months
After 40 months
Number of episodes of ketoacidosis
Time Frame: After 40 months
After 40 months
Number of episodes of severe hypoglycaemia
Time Frame: After 40 months
After 40 months
Long-term complications
Time Frame: After 40 months
After 40 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of children with HbA1c equal to or below 8.0
Time Frame: After 40 months
After 40 months
Percentage of children who died during the study
Time Frame: After 40 months
After 40 months
Percentage of children lost to follow-up
Time Frame: After 40 months
After 40 months

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.

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

September 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

March 3, 2015

First Submitted That Met QC Criteria

March 3, 2015

First Posted (Estimate)

March 9, 2015

Study Record Updates

Last Update Posted (Estimate)

March 9, 2015

Last Update Submitted That Met QC Criteria

March 3, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INS-3982
  • U1111-1149-2666 (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.

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