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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01493388
• Other study ID #: INS-3914
• Secondary ID: U1111-1124-9862
• Status: Completed
• Phase: N/A
• First received: December 14, 2011
• Last updated: January 18, 2017
• Start date: March 2012
• Est. completion date: July 2012

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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

Locations

Country	Name	City	State
Tunisia	Novo Nordisk Investigational Site	Tunisia

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Tunisia, 

References & 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

Outcome

Type	Measure	Description	Time frame	Safety issue
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)
Primary	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)
Primary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

•   Clinical Trials at Novo Nordisk