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Clinical Trials/NCT02382757
NCT02382757TerminatedNot Applicable

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

Novo Nordisk A/S0 sites3,089 target enrollmentStarted: September 2011Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
3,089
Primary Endpoint
Patient assessments: Number of days on insulin
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
— to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Children

Intervention: insulin human (Drug)

Outcomes

Primary Outcomes

Patient assessments: Number of days on insulin

Time Frame: After 40 months

Long-term complications

Time Frame: After 40 months

Number of episodes of severe hypoglycaemia

Time Frame: After 40 months

Number of days with home blood glucose monitoring

Time Frame: After 40 months

HbA1c (glycosylated haemoglobin)

Time Frame: After 40 months

Number of episodes of ketoacidosis

Time Frame: After 40 months

Secondary Outcomes

  • Percentage of children who died during the study(After 40 months)
  • Percentage of children lost to follow-up(After 40 months)
  • Percentage of children with HbA1c equal to or below 8.0(After 40 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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