Clinical trial NCT01493388: To Estimate the Percentage of Children and Adolescents in Tunisia With Acceptably Controlled Diabetes Mellitus Type 1
Official title: Observational, Cross-sectional and Retrospective Study on Diabetes Mellitus Type 1 in Tunisian Children and Adolescents Under 15 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-16
Enrollment: 402
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be treated according to routine clinical practice at the discretion of the treating physician.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Previous participation in this study.
* Current participation to a clinical trial

Primary outcomes:
measure: Percentage of children below 6 years with HbA1c less than 8.5%
timeFrame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
measure: Percentage of children between 6-12 years with HbA1c less than 8%
timeFrame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
measure: Percentage of adolescents between 13 and 15 years with HbA1c less than 7.5%
timeFrame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
Secondary outcomes:
measure: Fasting plasma glucose (FPG) level
timeFrame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
measure: Blood pressure level in children 12 years or older
timeFrame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
measure: Total cholesterol and LDL-cholesterol levels in children 12 years or older
timeFrame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
measure: Percentage of children with evaluation of thyroid function within the last 2 years
timeFrame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
measure: Percentage of children with nephropathy
timeFrame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
measure: Percentage of children with microalbuminuria
timeFrame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
measure: Percentage of children with hypoglycemia event having led to hospitalization
timeFrame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
measure: Percentage of children with self-monitoring of blood-glucose
timeFrame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
measure: Percentage of parents and children having received at least one training and topic of the received training
timeFrame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
measure: Type and dose of insulin treatment
timeFrame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
Other outcomes:
Locations:
city: Tunisia
country: Tunisia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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