DiabetesNCT01493388
To Estimate the Percentage of Children and Adolescents in Tunisia With Acceptably Controlled Diabetes Mellitus Type 1
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Tunisia.
Trial summary
This study is conducted in Africa. The aim of this study is to estimate the percentage of children and adolescents below or equal to 15 years in Tunisia with acceptably controlled diabetes mellitus type 1. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1
- What is being tested?
- insulin
- How many people
- 402 participants
- Where
- 1 siteTunisia
- Study dates
- Mar 2012to Jul 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients will be treated according to routine clinical practice at the discretion of the treating physician.
Who may be able to join
- Written informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol).
- Child or adolescent below or equal to 15 years with diabetes mellitus type 1
- Who has been undergoing treatment for diabetes for at least 6 months
Who cannot join
- Previous participation in this study.
- Current participation to a clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational, Cross-sectional and Retrospective Study on Diabetes Mellitus Type 1 in Tunisian Children and Adolescents Under 15 Years
This study is conducted in Africa. The aim of this study is to estimate the percentage of children and adolescents below or equal to 15 years in Tunisia with acceptably controlled diabetes mellitus type 1.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- insulin
- 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.
insulinDrug
Patients will be treated according to routine clinical practice at the discretion of the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Drug: insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of children below 6 years with HbA1c less than 8.5%
Measured: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
Percentage of children between 6-12 years with HbA1c less than 8%
Measured: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
Percentage of adolescents between 13 and 15 years with HbA1c less than 7.5%
Measured: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
Secondary outcomes (10)
Fasting plasma glucose (FPG) level
Measured: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
Blood pressure level in children 12 years or older
Measured: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
Total cholesterol and LDL-cholesterol levels in children 12 years or older
Measured: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
Percentage of children with evaluation of thyroid function within the last 2 years
Measured: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
Percentage of children with nephropathy
Measured: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
Percentage of children with microalbuminuria
Measured: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
Percentage of children with hypoglycemia event having led to hospitalization
Measured: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
Percentage of children with self-monitoring of blood-glucose
Measured: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
Percentage of parents and children having received at least one training and topic of the received training
Measured: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
Type and dose of insulin treatment
Measured: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2011 (estimated)
- Study startMar 2012
- Primary completionJul 2012
- Study completionJul 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 402 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
- NCT01493388
- Sponsor's protocol ID
- INS-3914
- Other IDs
- U1111-1124-9862
- Status last verified
- Jan 2017
- First submitted
- 14 Dec 2011
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hachicha M, Kamoun T, Briki S, Ouamara N. Étude observationnelle sur le diabète de type 1 chez les enfants et les adolescents de moins de 15 ans. La Revue Maghrebine d'Endocrinologie - Diabète et Reproduction; 19 (4): 144-149
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Cross-sectional and Retrospective Study on Diabetes Mellitus Type 1 in Tunisian Children and Adolescents Under 15 Years
- ClinicalTrials.gov ID
- NCT01493388
- Acronym / sponsor ID
- INS-3914
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 16 Dec 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 study is to estimate the percentage of children and adolescents below or equal to 15 years in Tunisia with acceptably controlled diabetes mellitus type 1.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: insulin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will be treated according to routine clinical practice at the discretion of the treating physician.
Key inclusion criteria (3 listed)
- Written informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol).
- Child or adolescent below or equal to 15 years with diabetes mellitus type 1
- Who has been undergoing treatment for diabetes for at least 6 months
Key exclusion criteria (2 listed)
- Previous participation in this study.
- Current participation to a clinical trial
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 |
|---|---|---|
| insulinPatients will be treated according to routine clinical practice at the discretion of the treating physician. | Drug | A |
Primary outcome
Percentage of children below 6 years with HbA1c less than 8.5%
Time frame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
Percentage of children between 6-12 years with HbA1c less than 8%
Time frame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
Percentage of adolescents between 13 and 15 years with HbA1c less than 7.5%
Time frame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
10 secondary outcomes
Fasting plasma glucose (FPG) level
Time frame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
Blood pressure level in children 12 years or older
Time frame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
Total cholesterol and LDL-cholesterol levels in children 12 years or older
Time frame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
Percentage of children with evaluation of thyroid function within the last 2 years
Time frame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
Percentage of children with nephropathy
Time frame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
Percentage of children with microalbuminuria
Time frame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
Percentage of children with hypoglycemia event having led to hospitalization
Time frame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
Percentage of children with self-monitoring of blood-glucose
Time frame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
Percentage of parents and children having received at least one training and topic of the received training
Time frame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
Type and dose of insulin treatment
Time frame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
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 19 Jan 2017.
- Results publicationHachicha M, Kamoun T, Briki S, Ouamara N. Étude observationnelle sur le diabète de type 1 chez les enfants et les adolescents de moins de 15 ans. La Revue Maghrebine d'Endocrinologie - Diabète et Reproduction; 19 (4): 144-149
- Clinical Trials at Novo NordiskLink provided by the sponsor.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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 Tunisia.
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 2 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 19 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 Tunisia. 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?
Percentage of children below 6 years with HbA1c less than 8.5% (time frame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)). The study lists 3 primary outcomes in all. 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 NCT01493388, 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 19 Jan 2017.