Try our beta test site

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01493388
First received: December 14, 2011
Last updated: January 18, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention
Diabetes
Diabetes Mellitus, Type 1
Drug: insulin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Observational, Cross-sectional and Retrospective Study on Diabetes Mellitus Type 1 in Tunisian Children and Adolescents Under 15 Years

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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) ]

Secondary Outcome Measures:
  • 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) ]

Enrollment: 402
Study Start Date: March 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: insulin
Patients will be treated according to routine clinical practice at the discretion of the treating physician.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be treated according to routine clinical practice at the discretion of the treating physician.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493388

Locations
Tunisia
Novo Nordisk Investigational Site
Tunisia, Tunisia, 1053
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
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

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01493388     History of Changes
Other Study ID Numbers: INS-3914  U1111-1124-9862 
Study First Received: December 14, 2011
Last Updated: January 18, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on February 20, 2017