A Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Children With Type 1 Diabetes

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes
• Interventions: Other: No treatment given

• Registration Number: NCT01435642
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Africa. The aim of this non-interventional study is to evaluate the current status of diabetes management, complications and psychosocial aspects for children with type 1 diabetes in Algeria.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-08-31
• Study Start: 2011-09
• Study First Submitted QC: 2011-09-15
• Study First Posted: 2011-09-16
• Primary Completion: 2012-01
• Study Completion: 2012-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-19
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 349

Inclusion Criteria

• Informed consent obtained from the patient and his legal representative before any study-related activities (Study-related activities are any procedure related to recording of data according to the protocol)
• Type 1 diabetes
• Time since diabetes diagnosed at least 5 years
• Followed for diabetes at consultation for at least 12 months

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Exclusion Criteria

• Patient previously included in this study
• Secondary diabetes
• Pregnant patient
• Patient consulting for an emergency

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	No treatment given	-

Primary Outcome Measures

Name	Time	Method
Mean HbA1c (glycosylated haemoglobin)	At the first visit (only one study visit) after 12 month of follow up

Secondary Outcome Measures

Name	Time	Method
Percentage of patients on insulin therapy	At the first visit (only one study visit) after 12 month of follow up
Mean duration of insulin therapy	At the first visit (only one study visit) after 12 month of follow up
Mean number of insulin injections/day	At the first visit (only one study visit) after 12 month of follow up
Mean insulin units per day	At the first visit (only one study visit) after 12 month of follow up
Percentage of patients having complications (ophthalmological, peripheral, renal and others)	At the first visit (only one study visit) after 12 month of follow up
To quantify quality of life	At the first visit (only one study visit) after 12 month of follow up
Percentage of patients on OAD or other treatments	At the first visit (only one study visit) after 12 month of follow up

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇿 Blida, Algeria