Changing Diabetes in Children

Diabetes Clinical Trial

— CDiC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02382757
• Other study ID #: INS-3982
• Secondary ID: U1111-1149-2666
• Status: Terminated
• Phase: N/A
• First received: March 3, 2015
• Last updated: March 3, 2015
• Start date: September 2011
• Est. completion date: November 2012

Study information

• Verified date: February 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3089
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient assessments: Number of days on insulin		After 40 months	No
Primary	Number of days with home blood glucose monitoring		After 40 months	No
Primary	HbA1c (glycosylated haemoglobin)		After 40 months	No
Primary	Number of episodes of ketoacidosis		After 40 months	No
Primary	Number of episodes of severe hypoglycaemia		After 40 months	No
Primary	Long-term complications		After 40 months	No
Secondary	Percentage of children with HbA1c equal to or below 8.0		After 40 months	No
Secondary	Percentage of children who died during the study		After 40 months	No
Secondary	Percentage of children lost to follow-up		After 40 months	No

External Links

•   Clinical Trials at Novo Nordisk