Changing Diabetes in Children
- Registration Number
- NCT02382757
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3089
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Children insulin human -
- Primary Outcome Measures
Name Time Method Patient assessments: Number of days on insulin After 40 months Long-term complications After 40 months Number of episodes of severe hypoglycaemia After 40 months Number of days with home blood glucose monitoring After 40 months HbA1c (glycosylated haemoglobin) After 40 months Number of episodes of ketoacidosis After 40 months
- Secondary Outcome Measures
Name Time Method 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