A Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Children With Type 1 Diabetes
Diabcare
Diabcare Paediatric - A Survey-study on Diabetes Management, Complications and Psychosocial Aspects of Type 1 Childhood Diabetics
2 other identifiers
observational
349
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedFirst Posted
Study publicly available on registry
September 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJanuary 20, 2017
January 1, 2017
4 months
August 31, 2011
January 19, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Mean HbA1c (glycosylated haemoglobin)
At the first visit (only one study visit) after 12 month of follow up
Secondary Outcomes (7)
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 on OAD or other treatments
At the first visit (only one study visit) after 12 month of follow up
- +2 more secondary outcomes
Study Arms (1)
A
Interventions
Subject will fill out a questionnaire when entering the non-interventional study
Eligibility Criteria
Children with type 1 diabetes mellitus being treated at diabetes clinics will be selected according to the inclusion and exclusion criteria.
You may qualify if:
- 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
You may not qualify if:
- Patient previously included in this study
- Secondary diabetes
- Pregnant patient
- Patient consulting for an emergency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Blida, 16009, Algeria
Related 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
RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2011
First Posted
September 16, 2011
Study Start
September 1, 2011
Primary Completion
January 1, 2012
Study Completion
December 1, 2012
Last Updated
January 20, 2017
Record last verified: 2017-01