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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1124-9862 | Other Identifier | WHO |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin | Drug | Patients will be treated according to routine clinical practice at the discretion of the treating physician. |
|
| Measure | Description | 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) |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be treated according to routine clinical practice at the discretion of the treating physician.
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Tunisia | 1053 | Tunisia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| 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 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 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 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) |
| 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) |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |