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

Diabetes Clinical Trial

— Diabcare  

Official title:

Diabcare Paediatric - A Survey-study on Diabetes Management, Complications and Psychosocial Aspects of Type 1 Childhood Diabetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01435642
• Other study ID #: INS-3956
• Secondary ID: U1111-1122-1671
• Status: Completed
• Phase: N/A
• First received: August 31, 2011
• Last updated: January 19, 2017
• Start date: September 2011
• Est. completion date: December 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 non-interventional study is to evaluate the current status of diabetes management, complications and psychosocial aspects for children with type 1 diabetes in Algeria.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 349
• Est. completion date: December 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Exclusion Criteria:

• Patient previously included in this study

• Secondary diabetes

• Pregnant patient

• Patient consulting for an emergency

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Other:
• No treatment given
Subject will fill out a questionnaire when entering the non-interventional study

Locations

Country	Name	City	State
Algeria	Novo Nordisk Investigational Site	Blida

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Algeria, 

References & Publications (1)

La prise en charge du diabéte de type 1 chez l'enfant en Algérie (DiabCare Pédiatrique); Bensenouci A, Achir M et al.; Médecine des Maladies Métaboliques 2015; Doi: 10.1016/S1957-2557(14)70902-2

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean HbA1c (glycosylated haemoglobin)		At the first visit (only one study visit) after 12 month of follow up
Secondary	Percentage of patients on insulin therapy		At the first visit (only one study visit) after 12 month of follow up
Secondary	Mean duration of insulin therapy		At the first visit (only one study visit) after 12 month of follow up
Secondary	Mean number of insulin injections/day		At the first visit (only one study visit) after 12 month of follow up
Secondary	Mean insulin units per day		At the first visit (only one study visit) after 12 month of follow up
Secondary	Percentage of patients on OAD or other treatments		At the first visit (only one study visit) after 12 month of follow up
Secondary	Percentage of patients having complications (ophthalmological, peripheral, renal and others)		At the first visit (only one study visit) after 12 month of follow up
Secondary	To quantify quality of life		At the first visit (only one study visit) after 12 month of follow up

External Links

•   Clinical Trials at Novo Nordisk