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Changing Diabetes® World Tour

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ClinicalTrials.gov Identifier: NCT01437072
Recruitment Status : Completed
First Posted : September 20, 2011
Last Update Posted : January 19, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study is conducted in the Middle East, Northern Africa and Europe. The aim of this study is to contribute to the design of a simple screening strategy for countries in scope, by exploring the association between risk factors and undiagnosed diabetes in a screening study.

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Other: No treatment given

Study Design

Study Type : Observational
Actual Enrollment : 8304 participants
Time Perspective: Cross-Sectional
Official Title: Changing Diabetes® World Tour a Study on the Association of Risk Factors and the Presence of Undiagnosed Diabetes in the Middle East, Northern Africa and Europe
Study Start Date : November 2010
Primary Completion Date : November 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Total study population Other: No treatment given
The screening test includes a combination of a risk assessment questionnaire and biochemical tests.

Outcome Measures

Primary Outcome Measures :
  1. HbA1c (Glycosylated Haemoglobin) level [ Time Frame: measured at the screening visit (only 1 visit during the 2 weeks stay of the bus in each country) ]

Secondary Outcome Measures :
  1. Number of subjects with diabetes (type 1 and 2) [ Time Frame: measured at the screening visit (only 1 visit during the 2 weeks stay of the bus in each country) ]
  2. The presence of retinopathy [ Time Frame: measured at the screening visit (only 1 visit during the 2 weeks stay of the bus in each country) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The Changing Diabetes® World Tour is designed as a mobile screening clinic staying for a minimum of 14 days in each location such as malls, public squares, etc. Subjects included in the study are either actively seeking to be screened, or are invited by subjects in their network already included in the study.

Inclusion Criteria:

  • Informed consent obtained

Exclusion Criteria:

  • Subjects with known diabetes (exception: women with a history of gestational diabetes should not be excluded)
  • Pregnant women or women who have given birth within less than a month
  • Subjects suffering from severe illness
  • Subjects with the inability to read and understand the information given (either due to illiteracy or vision problems) and therefore unable to give an informed consent
  • Subjects with mental impairment
  • Subjects treated with systemic cortico-steroids
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01437072

Novo Nordisk Investigational Site
Paco de Arcos, Portugal, 2780-730
Saudi Arabia
Novo Nordisk Investigational Site
Riyadh, Saudi Arabia, 3542
United Arab Emirates
Novo Nordisk Investigational Site
Dubai, United Arab Emirates
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01437072     History of Changes
Other Study ID Numbers: INS-3934
U1111-1123-4683 ( Other Identifier: WHO )
First Posted: September 20, 2011    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases