Changing Diabetes in Children

NCT02382757 | Terminated

• 2 other identifiers: INS-3982U1111-1149-2666
• Study Type: observational
• Target: 3,089
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (6)

• Patient assessments: Number of days on insulin

  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

• Number of episodes of severe hypoglycaemia

  After 40 months

• Long-term complications

  After 40 months

Secondary Outcomes (3)

• Percentage of children with HbA1c equal to or below 8.0

  After 40 months

• Percentage of children who died during the study

  After 40 months

• Percentage of children lost to follow-up

  After 40 months

Study Arms (1)

Children

Drug: insulin human

Interventions

insulin human DRUG

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

Children

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Children diagnosed with type 1 diabetes
• Parents/caretakers agree to participate in the study

You may not qualify if:

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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Bangalore, 560001, India

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2015
• First Posted: March 9, 2015
• Study Start: September 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: March 9, 2015

Record last verified: 2015-02

Locations

IN (1)