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

NCT01493388 | Completed

• 2 other identifiers: INS-3914U1111-1124-9862
• Study Type: observational
• Target: 402
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• 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)

Study Arms (1)

A

Drug: insulin

Interventions

insulin DRUG

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

A

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Previous participation in this study.
• Current participation to a clinical trial

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Tunisia, 1053, Tunisia

Location

Related Publications (1)

• 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

  RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2011
• First Posted: December 16, 2011
• Study Start: March 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: January 19, 2017

Record last verified: 2017-01

Locations

TU (1)