Changing Diabetes® World Tour

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes; Diabetes Mellitus, Type 2
• Interventions: Other: No treatment given

• Registration Number: NCT01437072
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-09-08
• Study First Submitted QC: 2011-09-16
• Study First Posted: 2011-09-20
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8304

Inclusion Criteria

• Informed consent obtained

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Total study population	No treatment given	-

Primary Outcome Measures

Name	Time	Method
HbA1c (Glycosylated Haemoglobin) level	measured at the screening visit (only 1 visit during the 2 weeks stay of the bus in each country)

Secondary Outcome Measures

Name	Time	Method
The presence of retinopathy	measured at the screening visit (only 1 visit during the 2 weeks stay of the bus in each country)
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)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇦🇪 Dubai, United Arab Emirates