Changing Diabetes in Children

Novo Nordisk A/S3,089 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

3,089

Conditions

Diabetes Diabetes Mellitus, Type 1

Interventions

insulin humanDRUG

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

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Bangalore, India

Outcomes

Primary Outcomes

Patient assessments: Number of days on insulin

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

Number of episodes of severe hypoglycaemia

Time frame: After 40 months

Long-term complications

Time frame: After 40 months

Secondary Outcomes

Percentage of children with HbA1c equal to or below 8.0

Time frame: After 40 months

Percentage of children who died during the study

Time frame: After 40 months

Percentage of children lost to follow-up

Time frame: After 40 months

Data from ClinicalTrials.gov

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