Diabetes, Diabetes Mellitus, Type 1
Conditions
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.
Interventions
DRUGinsulin
Patients will be treated according to routine clinical practice at the discretion of the treating physician.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of children below 6 years with HbA1c less than 8.5% | 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% | 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% | one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1) |
Secondary
| Measure | Time frame |
|---|---|
| Fasting plasma glucose (FPG) level | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1) |
Countries
Tunisia
Outcome results
None listed