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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 March 2015 |
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Main ID: |
NCT02382757 |
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Date of registration:
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03/03/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Changing Diabetes in Children
CDiC |
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Scientific title:
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Changing Diabetes in Children (CDiC): Type 1 Diabetes in Economically Underprivileged Children in India |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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3089 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT02382757 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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India
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Contacts
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Name:
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Global Clinical Registry (GCR, 1452) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novo Nordisk A/S |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes
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Diabetes Mellitus, Type 1
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Intervention(s)
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Drug: insulin human
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Primary Outcome(s)
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Number of days with home blood glucose monitoring
[Time Frame: After 40 months]
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HbA1c (glycosylated haemoglobin)
[Time Frame: After 40 months]
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Patient assessments: Number of days on insulin
[Time Frame: After 40 months]
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Long-term complications
[Time Frame: After 40 months]
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Number of episodes of ketoacidosis
[Time Frame: After 40 months]
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Number of episodes of severe hypoglycaemia
[Time Frame: After 40 months]
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Secondary Outcome(s)
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Percentage of children who died during the study
[Time Frame: After 40 months]
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Percentage of children with HbA1c equal to or below 8.0
[Time Frame: After 40 months]
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Percentage of children lost to follow-up
[Time Frame: After 40 months]
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Secondary ID(s)
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U1111-1149-2666
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INS-3982
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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