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Completed

NCT Number: NCT01493388

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

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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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Tunisia, 1053

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin

Drug

Patients will be treated according to routine clinical practice at the discretion of the treating physician.

Primary outcomes

  1. 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)

  2. 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)

  3. 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 outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Observational, Cross-sectional and Retrospective Study on Diabetes Mellitus Type 1 in Tunisian Children and Adolescents Under 15 Years

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Dec 16, 2011
Registry last updated
Jan 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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