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Changing Diabetes® World Tour

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01437072
First received: September 8, 2011
Last updated: December 22, 2011
Last verified: December 2011
History of Changes
  Purpose

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 Intervention
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
 Other: No treatment given

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Changing Diabetes® World Tour Protocol for a Study on the Association of Risk Factors and the Presence of Undiagnosed Diabetes in the Middle East, Northern Africa and Europe

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 8304
Study Start Date: November 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Total study population Other: No treatment given
The screening test includes a combination of a risk assessment questionnaire and biochemical tests.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437072

Locations
Algeria
Algiers, Algeria, 16035
Portugal
Paco de Arcos, Portugal, 2780-730
Saudi Arabia
Riyadh, Saudi Arabia, 3542
United Arab Emirates
Dubai, United Arab Emirates
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Ole Henriksen Novo Nordisk
Study Director: Louise Bjerregård Nielsen Novo Nordisk
  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: NCT01437072     History of Changes
Other Study ID Numbers: INS-3934, U1111-1123-4683
Study First Received: September 8, 2011
Last Updated: December 22, 2011
Health Authority: Portugal: Not required for observational study
Algeria: Ministry of Health
Saudi Arabia: Ministry of Health
United Arab Emirates: Ministry of Health

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

ClinicalTrials.gov processed this record on May 16, 2013