Changing Diabetes® World Tour
2 other identifiers
observational
8,304
3 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2010
Shorter than P25 for all trials
3 active sites
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
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 8, 2011
CompletedFirst Posted
Study publicly available on registry
September 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedJanuary 19, 2017
January 1, 2017
1 year
September 8, 2011
January 18, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c (Glycosylated Haemoglobin) level
measured at the screening visit (only 1 visit during the 2 weeks stay of the bus in each country)
Secondary Outcomes (2)
Number of subjects with diabetes (type 1 and 2)
measured at the screening visit (only 1 visit during the 2 weeks stay of the bus in each country)
The presence of retinopathy
measured at the screening visit (only 1 visit during the 2 weeks stay of the bus in each country)
Study Arms (1)
Total study population
Interventions
The screening test includes a combination of a risk assessment questionnaire and biochemical tests.
Eligibility Criteria
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.
You may qualify if:
- Informed consent obtained
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (3)
Novo Nordisk Investigational Site
Paço de Arcos, 2780-730, Portugal
Novo Nordisk Investigational Site
Riyadh, 3542, Saudi Arabia
Novo Nordisk Investigational Site
Dubai, United Arab Emirates
Related Publications (1)
Handlos LN, Witte DR, Almdal TP, Nielsen LB, Badawi SE, Sheikh AR, Belhadj M, Nadir D, Zinai S, Vistisen D. Risk scores for diabetes and impaired glycaemia in the Middle East and North Africa. Diabet Med. 2013 Apr;30(4):443-51. doi: 10.1111/dme.12118.
PMID: 23331167RESULT
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
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2011
First Posted
September 20, 2011
Study Start
November 1, 2010
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
January 19, 2017
Record last verified: 2017-01