DiabetesNCT01437072
Changing Diabetes® World Tour
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- No treatment given
- How many people
- 8,304 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Nov 2010to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Informed consent obtained
Who cannot join
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United Arab Emirates1 site
Novo Nordisk Investigational Site
Dubai
About this study
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
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.
- Being tested
- No treatment given
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment givenOther
The screening test includes a combination of a risk assessment questionnaire and biochemical tests.
| Study group | Role | What they receive |
|---|---|---|
| Total study population | Not described Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c (Glycosylated Haemoglobin) level
Measured: 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: measured at the screening visit (only 1 visit during the 2 weeks stay of the bus in each country)
The presence of retinopathy
Measured: measured at the screening visit (only 1 visit during the 2 weeks stay of the bus in each country)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2011 (estimated)
- Study startNov 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 8,304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01437072
- Sponsor's protocol ID
- INS-3934
- Other IDs
- U1111-1123-4683
- Status last verified
- Jan 2017
- First submitted
- 8 Sep 2011
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23331167
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01437072
- Acronym / sponsor ID
- INS-3934
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,304 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 20 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total study population | – | Other: No treatment given |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Informed consent obtained
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No treatment givenThe screening test includes a combination of a risk assessment questionnaire and biochemical tests. | Other | Total study population |
Primary outcome
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)
2 secondary outcomes
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
- Results publication: PubMed 23331167Handlos 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.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Portugal, Saudi Arabia, United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01437072, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2017.