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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01435642
First received: August 31, 2011
Last updated: January 25, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
Diabetes
Diabetes Mellitus, Type 1
 Other: No treatment given

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Diabcare Paediatric - A Survey-study on Diabetes Management, Complications and Psychosocial Aspects of Type 1 Childhood Diabetics

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Mean HbA1c (glycosylated haemoglobin) [ Time Frame: At the first visit (only one study visit) after 12 month of follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients on insulin therapy [ Time Frame: At the first visit (only one study visit) after 12 month of follow up ] [ Designated as safety issue: No ]
  • Mean duration of insulin therapy [ Time Frame: At the first visit (only one study visit) after 12 month of follow up ] [ Designated as safety issue: No ]
  • Mean number of insulin injections/day [ Time Frame: At the first visit (only one study visit) after 12 month of follow up ] [ Designated as safety issue: No ]
  • Mean insulin units per day [ Time Frame: At the first visit (only one study visit) after 12 month of follow up ] [ Designated as safety issue: No ]
  • Percentage of patients on OAD or other treatments [ Time Frame: At the first visit (only one study visit) after 12 month of follow up ] [ Designated as safety issue: No ]
  • Percentage of patients having complications (ophthalmological, peripheral, renal and others) [ Time Frame: At the first visit (only one study visit) after 12 month of follow up ] [ Designated as safety issue: No ]
  • To quantify quality of life [ Time Frame: At the first visit (only one study visit) after 12 month of follow up ] [ Designated as safety issue: No ]

Enrollment: 365
Study Start Date: September 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Other: No treatment given
Subject will fill out a questionnaire when entering the non-interventional study

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children with type 1 diabetes mellitus being treated at diabetes clinics will be selected according to the inclusion and exclusion criteria.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01435642

Locations
Algeria
Blida, Algeria, 16009
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Lilya Maya Ziad Novo Nordisk Algeria
Study Director: Kherdine Yahia-Ouahmed Novo Nordisk Algeria
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT01435642     History of Changes
Other Study ID Numbers: INS-3956, U1111-1122-1671
Study First Received: August 31, 2011
Last Updated: January 25, 2012
Health Authority: Algeria: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on June 18, 2013