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OpenTrials
Completed

NCT Number: NCT01435642

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

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.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Blida, 16009, Algeria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No treatment given

Other

Subject will fill out a questionnaire when entering the non-interventional study

Primary outcomes

  1. Mean HbA1c (glycosylated haemoglobin)

    Time frame: At the first visit (only one study visit) after 12 month of follow up

Secondary outcomes

  1. Percentage of patients on insulin therapy

    Time frame: At the first visit (only one study visit) after 12 month of follow up

  2. Mean duration of insulin therapy

    Time frame: At the first visit (only one study visit) after 12 month of follow up

  3. Mean number of insulin injections/day

    Time frame: At the first visit (only one study visit) after 12 month of follow up

  4. Mean insulin units per day

    Time frame: At the first visit (only one study visit) after 12 month of follow up

  5. Percentage of patients on OAD or other treatments

    Time frame: At the first visit (only one study visit) after 12 month of follow up

  6. 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

  7. To quantify quality of life

    Time frame: At the first visit (only one study visit) after 12 month of follow up

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Acronym: Diabcare

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 16, 2011
Registry last updated
Jan 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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