DiabetesDiabcareNCT01435642
A Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Children With Type 1 Diabetes
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Algeria.
Trial summary
This study is conducted in Africa. The aim of this non-interventional study is to evaluate the current status of diabetes management, complications and psychosocial aspects for children with type 1 diabetes in Algeria. 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?
- No treatment given
- How many people
- 349 participants
- Where
- 1 siteAlgeria
- Study dates
- Sep 2011to Dec 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 mellitus being treated at diabetes clinics will be selected according to the inclusion and exclusion criteria.
Who may be able to join
- Informed consent obtained from the patient and his legal representative before any study-related activities (Study-related activities are any procedure related to recording of data according to the protocol)
- Type 1 diabetes
- Time since diabetes diagnosed at least 5 years
- Followed for diabetes at consultation for at least 12 months
Who cannot join
- Patient previously included in this study
- Secondary diabetes
- Pregnant patient
- Patient consulting for an emergency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diabcare Paediatric - A Survey-study on Diabetes Management, Complications and Psychosocial Aspects of Type 1 Childhood Diabetics
This study is conducted in Africa. The aim of this non-interventional study is to evaluate the current status of diabetes management, complications and psychosocial aspects for children with type 1 diabetes in Algeria.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- No treatment given
- 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.
No treatment givenOther
Subject will fill out a questionnaire when entering the non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean HbA1c (glycosylated haemoglobin)
Measured: At the first visit (only one study visit) after 12 month of follow up
Secondary outcomes (7)
Percentage of patients on insulin therapy
Measured: At the first visit (only one study visit) after 12 month of follow up
Mean duration of insulin therapy
Measured: At the first visit (only one study visit) after 12 month of follow up
Mean number of insulin injections/day
Measured: At the first visit (only one study visit) after 12 month of follow up
Mean insulin units per day
Measured: At the first visit (only one study visit) after 12 month of follow up
Percentage of patients on OAD or other treatments
Measured: At the first visit (only one study visit) after 12 month of follow up
Percentage of patients having complications (ophthalmological, peripheral, renal and others)
Measured: At the first visit (only one study visit) after 12 month of follow up
To quantify quality of life
Measured: At the first visit (only one study visit) after 12 month of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionJan 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 349 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
- NCT01435642
- Sponsor's protocol ID
- INS-3956
- Other IDs
- U1111-1122-1671
- Acronym
- Diabcare
- Status last verified
- Jan 2017
- First submitted
- 31 Aug 2011
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
La prise en charge du diabéte de type 1 chez l'enfant en Algérie (DiabCare Pédiatrique); Bensenouci A, Achir M et al.; Médecine des Maladies Métaboliques 2015; Doi: 10.1016/S1957-2557(14)70902-2
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabcare Paediatric - A Survey-study on Diabetes Management, Complications and Psychosocial Aspects of Type 1 Childhood Diabetics
- ClinicalTrials.gov ID
- NCT01435642
- Acronym / sponsor ID
- Diabcare / INS-3956
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 349 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Sep 2011 (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 Africa. The aim of this non-interventional study is to evaluate the current status of diabetes management, complications and psychosocial aspects for children with type 1 diabetes in Algeria.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Other: No treatment given |
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 mellitus being treated at diabetes clinics will be selected according to the inclusion and exclusion criteria.
Key inclusion criteria (4 listed)
- Informed consent obtained from the patient and his legal representative before any study-related activities (Study-related activities are any procedure related to recording of data according to the protocol)
- Type 1 diabetes
- Time since diabetes diagnosed at least 5 years
- Followed for diabetes at consultation for at least 12 months
Key exclusion criteria (4 listed)
- Patient previously included in this study
- Secondary diabetes
- Pregnant patient
- Patient consulting for an emergency
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 |
|---|---|---|
| No treatment givenSubject will fill out a questionnaire when entering the non-interventional study | Other | A |
Primary outcome
Mean HbA1c (glycosylated haemoglobin)
Time frame: At the first visit (only one study visit) after 12 month of follow up
7 secondary outcomes
Percentage of patients on insulin therapy
Time frame: At the first visit (only one study visit) after 12 month of follow up
Mean duration of insulin therapy
Time frame: At the first visit (only one study visit) after 12 month of follow up
Mean number of insulin injections/day
Time frame: At the first visit (only one study visit) after 12 month of follow up
Mean insulin units per day
Time frame: At the first visit (only one study visit) after 12 month of follow up
Percentage of patients on OAD or other treatments
Time frame: At the first visit (only one study visit) after 12 month of follow up
Percentage of patients having complications (ophthalmological, peripheral, renal and others)
Time frame: At the first visit (only one study visit) after 12 month of follow up
To quantify quality of life
Time frame: At the first visit (only one study visit) after 12 month of follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
- Results publicationLa prise en charge du diabéte de type 1 chez l'enfant en Algérie (DiabCare Pédiatrique); Bensenouci A, Achir M et al.; Médecine des Maladies Métaboliques 2015; Doi: 10.1016/S1957-2557(14)70902-2
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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 Algeria.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 20 Jan 2017. 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 Algeria. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean HbA1c (glycosylated haemoglobin) (time frame: At the first visit (only one study visit) after 12 month of follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01435642, which also lists 1 linked publication.
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 20 Jan 2017.