DiabetesCDiCNCT02382757
Changing Diabetes in Children
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1
- What is being tested?
- insulin human
- How many people
- 3,089 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2011to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with type 1 diabetes aged below 18 years will be included.
Who may be able to join
- 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)
Who cannot join
- Children with type 2 diabetes
- Children from higher economic status
- Those getting coverage under other government / private schemes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changing Diabetes in Children (CDiC): Type 1 Diabetes in Economically Underprivileged Children in India
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
- Being tested
- insulin human
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin humanDrug
Children will receive conventional treatment with human insulin according to standard medical practice.
| Study group | Role | What they receive |
|---|---|---|
| Children | Not described Receives: Drug: insulin human |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient assessments: Number of days on insulin
Measured: After 40 months
Number of days with home blood glucose monitoring
Measured: After 40 months
HbA1c (glycosylated haemoglobin)
Measured: After 40 months
Number of episodes of ketoacidosis
Measured: After 40 months
Number of episodes of severe hypoglycaemia
Measured: After 40 months
Long-term complications
Measured: After 40 months
Secondary outcomes (3)
Percentage of children with HbA1c equal to or below 8.0
Measured: After 40 months
Percentage of children who died during the study
Measured: After 40 months
Percentage of children lost to follow-up
Measured: After 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startSep 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,089 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382757
- Sponsor's protocol ID
- INS-3982
- Other IDs
- U1111-1149-2666
- Acronym
- CDiC
- Status last verified
- Feb 2015
- First submitted
- 3 Mar 2015
- Last updated
- 9 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing Diabetes in Children (CDiC): Type 1 Diabetes in Economically Underprivileged Children in India
- ClinicalTrials.gov ID
- NCT02382757
- Acronym / sponsor ID
- CDiC / INS-3982
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 3,089 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 9 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children | – | Drug: insulin human |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with type 1 diabetes aged below 18 years will be included.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Children with type 2 diabetes
- Children from higher economic status
- Those getting coverage under other government / private schemes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| insulin humanChildren will receive conventional treatment with human insulin according to standard medical practice. | Drug | Children |
Primary outcome
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
3 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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2015.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
Related trials for Diabetes
Active, not recruitingPhase 2
Islet Cell Transplant for Type 1 Diabetes
Type 1 Diabetes Mellitus
Active, not recruitingPhase 3
Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy
Lipodystrophy, Diabetes
RecruitingObservational study
Taste Bud-Derived Stem Cells in Humans
Diabetes
RecruitingObservational study
Human iPSC for Repair of Vasodegenerative Vessels in Diabetic Retinopathy
Diabetes Complications, Diabetic Retinopathy
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient assessments: Number of days on insulin (time frame: After 40 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2015; AzTrials last refreshed its copy on 27 Oct 2026.