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To Estimate the Percentage of Children and Adolescents in Tunisia With Acceptably Controlled Diabetes Mellitus Type 1

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ClinicalTrials.gov Identifier: NCT01493388
Recruitment Status : Completed
First Posted : December 16, 2011
Last Update Posted : January 19, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

December 14, 2011
December 16, 2011
January 19, 2017
March 2012
July 2012   (Final data collection date for 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) ]
  • 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) ]
  • Percentage of children below 6 years with HbA1c less than 8.5% [ Time Frame: registered at the study visit (only one) from patient medical records or interview ]
  • Percentage of children between 6-12 years with HbA1c less than 8% [ Time Frame: registered at the study visit (only one) from patient medical records or interview ]
  • Percentage of adolescents between 13 and 15 years with HbA1c less than 7.5% [ Time Frame: registered at the study visit (only one) from patient medical records or interview ]
Complete list of historical versions of study NCT01493388 on ClinicalTrials.gov Archive Site
  • 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) ]
  • Fasting plasma glucose (FPG) level [ Time Frame: registered at the study visit (only one) from patient medical records or interview ]
  • Blood pressure level in children 12 years or older [ Time Frame: registered at the study visit (only one) from patient medical records or interview ]
  • Total cholesterol and LDL-cholesterol levels in children 12 years or older [ Time Frame: registered at the study visit (only one) from patient medical records or interview ]
  • Percentage of children with evaluation of thyroid function within the last 2 years [ Time Frame: registered at the study visit (only one) from patient medical records or interview ]
  • Percentage of children with nephropathy [ Time Frame: registered at the study visit (only one) from patient medical records or interview ]
  • Percentage of children with microalbuminuria [ Time Frame: registered at the study visit (only one) from patient medical records or interview ]
  • Percentage of children with hypoglycemia event having led to hospitalization [ Time Frame: registered at the study visit (only one) from patient medical records or interview ]
  • Percentage of children with self-monitoring of blood-glucose [ Time Frame: registered at the study visit (only one) from patient medical records or interview ]
  • Percentage of parents and children having received at least one training and topic of the received training [ Time Frame: registered at the study visit (only one) from patient medical records or interview ]
  • Type and dose of insulin treatment [ Time Frame: registered at the study visit (only one) from patient medical records or interview ]
Not Provided
Not Provided
 
To Estimate the Percentage of Children and Adolescents in Tunisia With Acceptably Controlled Diabetes Mellitus Type 1
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
Patients will be treated according to routine clinical practice at the discretion of the treating physician.
  • Diabetes
  • Diabetes Mellitus, Type 1
Drug: insulin
Patients will be treated according to routine clinical practice at the discretion of the treating physician.
A
Intervention: Drug: insulin
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
402
Same as current
July 2012
July 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
Tunisia
 
 
NCT01493388
INS-3914
U1111-1124-9862 ( Other Identifier: WHO )
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2017