Insulin-Treated Diabetes MellitusNCT00661908
Diabetes-Related Discrimination at Workplace and by Insurances
An observational study of Insulin-Treated Diabetes Mellitus, run by University Hospital, Basel, Switzerland.
Trial summary
Diabetic subjects often report of problems at the workplace or when contracting insurances because of their diabetes. By distributing a self-report questionnaire to insulin-treated Type 1 and Type 2 diabetic subjects we wanted to analyse the frequency of work- and insurance-related discrimination. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Insulin-Treated Diabetes Mellitus
- How many people
- 509 participants
- Where
- No sites listed yet
- Study dates
- Mar 2004to Jan 2008
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Within a time period of two month we recruited all insulin-treated diabetic patients from the outpatient clinic of the University Hospital of Basel (n=203), from 5 regional hospitals (n=135) in the North-western part of Switzerland and from 13 specialist practices (n=107) as well as from 15 randomly selected general practioner practices (n=64)in the mentioned area.
Who may be able to join
- german-speaking insulin-treated diabetic patients
Who cannot join
- none
About this study
Official title: Discrimination of Insulin-Treated Diabetic Subjects at the Workplace and by Insurances
Diabetic subjects often report of problems at the workplace or when contracting insurances because of their diabetes.
By distributing a self-report questionnaire to insulin-treated Type 1 and Type 2 diabetic subjects we wanted to analyse the frequency of work- and insurance-related discrimination. Furthermore we wanted to detect socio-demographic and diabetes-related factors which are associated with increased discrimination at workplace and by insurances. We hypothesized that diabetes-related discrimination at workplace and by insurances exists and that certain factors like having severe hypoglycaemic events, being type 1 diabetic or being overweight would be associated with more problems at work or with insurances.
Read the detailed description
Our self report questionnaire included 83 items to assess treatment goals, quality of life and discrimination at workplace or by insurances. 636 questionnaires were distributed and were answered and returned. Anonymity was ensured. Patients were recruited from the diabetes outpatient clinic of the University of Basel Hospital, 5 regional hospitals, specialist practices and general practitioner practices.
The aims of this study are to investigate the prevalence of discrimination at workplace and by insurances due to diabetes mellitus. Furthermore we want analyse if socio-demographic factors (age,gender,origin) show an impact on diabetes-related discrimination at workplace and by insurances. We hypothesize furthermore that certain diabetes-related factors like having severe hypoglycemias, being type 1 diabetic, having diabetic complications or being overweight/obese is associated with more problems at work and with insurances.
Data will be analysed by a multiple ordinal regression analysis. We will correct data for age, gender, employment status and diabetes type.
- Conditions
- Insulin-Treated Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | insulin-treated diabetic subjects of North-western part of Switzerland |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startMar 2004
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin-Treated Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Diabetes Association Basel
- Investigators
- Piera M Nebiker, MD, Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661908
- Sponsor's protocol ID
- 274/03
- Status last verified
- Apr 2008
- First submitted
- 16 Apr 2008
- Last updated
- 21 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discrimination of Insulin-Treated Diabetic Subjects at the Workplace and by Insurances
- ClinicalTrials.gov ID
- NCT00661908
- Acronym / sponsor ID
- 274/03
- Conditions
- Insulin-Treated Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 509 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Diabetes Association Basel
- Study start
- Mar 2004
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 21 Apr 2008 (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.
Diabetic subjects often report of problems at the workplace or when contracting insurances because of their diabetes.
By distributing a self-report questionnaire to insulin-treated Type 1 and Type 2 diabetic subjects we wanted to analyse the frequency of work- and insurance-related discrimination. Furthermore we wanted to detect socio-demographic and diabetes-related factors which are associated with increased discrimination at workplace and by insurances. We hypothesized that diabetes-related discrimination at workplace and by insurances exists and that certain factors like having severe hypoglycaemic events, being type 1 diabetic or being overweight would be associated with more problems at work or with insurances.
Detailed description
Our self report questionnaire included 83 items to assess treatment goals, quality of life and discrimination at workplace or by insurances. 636 questionnaires were distributed and were answered and returned. Anonymity was ensured. Patients were recruited from the diabetes outpatient clinic of the University of Basel Hospital, 5 regional hospitals, specialist practices and general practitioner practices.
The aims of this study are to investigate the prevalence of discrimination at workplace and by insurances due to diabetes mellitus. Furthermore we want analyse if socio-demographic factors (age,gender,origin) show an impact on diabetes-related discrimination at workplace and by insurances. We hypothesize furthermore that certain diabetes-related factors like having severe hypoglycemias, being type 1 diabetic, having diabetic complications or being overweight/obese is associated with more problems at work and with insurances.
Data will be analysed by a multiple ordinal regression analysis. We will correct data for age, gender, employment status and diabetes type.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –insulin-treated diabetic subjects of North-western part of Switzerland |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Within a time period of two month we recruited all insulin-treated diabetic patients from the outpatient clinic of the University Hospital of Basel (n=203), from 5 regional hospitals (n=135) in the North-western part of Switzerland and from 13 specialist practices (n=107) as well as from 15 randomly selected general practioner practices (n=64)in the mentioned area.
Key inclusion criteria (1 listed)
- german-speaking insulin-treated diabetic patients
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 21 Apr 2008.
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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.
Piera M Nebiker, MD principal investigator
University of Basel
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin-Treated Diabetes Mellitus, run by University Hospital, Basel, Switzerland.
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 1 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 21 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
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 21 Apr 2008.