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 A/S
ClinicalTrials.gov Identifier:
NCT01435642
First received: August 31, 2011
Last updated: January 25, 2012
Last verified: January 2012
  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:


Further study details as provided by Novo Nordisk A/S:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
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 September 22, 2014