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

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1
• Interventions: Drug: insulin

• Registration Number: NCT01493388
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-14
• Study First Submitted QC: 2011-12-14
• Study First Posted: 2011-12-16
• Study Start: 2012-03
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 402

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	insulin	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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)
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)
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)
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)
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)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇹🇳 Tunisia, Tunisia