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Clinical Trial Details

Trial ID: L6267
Source ID: NCT01493388
Associated Drug: Insulin
Title: To Estimate the Percentage of Children and Adolescents in Tunisia With Acceptably Controlled Diabetes Mellitus Type 1
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes|Diabetes Mellitus, Type 1
Interventions: DRUG: insulin
Outcome Measures: Primary: 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: 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 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)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases:
Enrollment: 402
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2012-03
Completion Date: 2012-07
Results First Posted:
Last Update Posted: 2017-01-19
Locations: Novo Nordisk Investigational Site, Tunisia, 1053, Tunisia
URL: https://clinicaltrials.gov/show/NCT01493388