- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01179815
Swiss Diabetes Registry - SwissDiab Study (SwissDiab)
Swiss Diabetes Registry - SwissDiab Study, a Prospective Cohort Study of Patients With Diabetes in Switzerland
Currently, the estimated number of people with diabetes mellitus is approximately 387 million people worldwide. Due to population growth, urbanization, ageing and the rising prevalence of obesity the numbers of individuals with diabetes is increasing likewise. It has been shown that improving glycemic control is associated with a reduction in late complications of diabetes, such as cardiovascular and microvascular diseases. Therefore, treatment guidelines were established internationally by large and renowned associations and adopted by many countries.
For Switzerland only sparse data exist on the actual implementation of such recommendations and on patient's well-being. The Swiss Diabetes Registry - SwissDiab Study is a prospective cohort study aiming at including and collecting data of virtually all patients regularly seen and treated at the study centers (≈ 500 patients each), irrespective of type, duration of diabetes or treatment . This allows the evaluation of diabetes treatment strategies at these centers. Furthermore, risk indicators for micro- and macrovascular complications, mortality as well as costs and quality of life will be assessed. Data will be recorded through an internet-based, electronic database specifically designed for this study. At a later perspective it is planned to extend data collection to general practitioner/family doctor networks in order to include a larger and more representative sample of patients with diabetes in Switzerland.
Study Overview
Status
Conditions
Detailed Description
Background
Currently, approximately 387 million people worldwide are affected by Diabetes Mellitus.
Due to population growth, urbanization, ageing and the rising prevalence of obesity the numbers of individuals with diabetes will grow. The American Diabetes Association estimated the total cost of diabetes in the US in 2012 at $245 billion. The greatest share of those costs results from the treatment of diabetes-associated complications caused by prolonged hyperglycemia. There is compelling evidence that tight glycemic control and intensive treatment of other cardiovascular risk factors substantially reduce the risk of developing being also cost-effective. Our current knowledge, however, is mainly derived from intervention trials usually including strictly defined patient groups and are carried out according to meticulous study protocols. Observational studies, however, in unselected outpatient settings have revealed discrepancies between recommended treatment goals resulting from those latter studies and actual standard of care. There is a pressing need, therefore, to assess the standard of care and confirm the feasibility and effectiveness of proposed management trends in both specialty clinic and community-based cohorts.
Objective
- With the help of an internet-based, electronic database (webspirit®, www.swissdiab.ch): to collect representative cross-sectional data from all consenting patients seen and treated at the study centers in order to evaluate the current standard of care of patients with diabetes mellitus, the distribution of micro- and macrovascular complications, the use of medications and devices as well as aspects of costs and quality of life (QoL)
- To collect prospective data of those patients in relation to achievement of treatment goals, changes in management, risk factors for, incidence and progression of micro- and macrovascular complications, mortality as well as costs and quality of life using the same database
Methods
After obtaining informed consent, patients with diabetes mellitus willing to participate will be invited to an initial comprehensive assessment (baseline) performed at the three cantonal study centers (Inselspital Bern, Kantonsspital St. Gallen, Universitätsspital Zürich). This will be followed by face-to-face clinical/laboratory visits between one to four times yearly according to patient's individual management plans. Once a year a comprehensive review including clinical and laboratory screening for diabetes-specific complications is planned.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Markus Laimer, PD Dr. med.
- Phone Number: +41 31 632 30 62
- Email: Markus.Laimer@insel.ch
Study Contact Backup
- Name: Christoph Stettler, Prof.
- Phone Number: +41 31 632 40 70
- Email: christoph.stettler@insel.ch
Study Locations
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-
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Bern, Switzerland, 3010
- Recruiting
- Universitätspoliklinik für Endokrinologie, Diabetologie und Klinische Ernährung, Inselspital Bern
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Contact:
- Markus Laimer, PD Dr. med.
- Phone Number: +41 31 632 30 62
- Email: Markus.Laimer@insel.ch
-
Contact:
- Christoph Stettler, Prof.
- Phone Number: +41 31 632 40 70
- Email: christoph.stettler@insel.ch
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Principal Investigator:
- Markus Laimer, PD Dr. med.
-
Sub-Investigator:
- Peter Diem, Prof.
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Sub-Investigator:
- Katja Müller-Fischer, Dr. med.
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Lausanne, Switzerland
- Recruiting
- Service d'endocrinologie, diabétologie et métabolisme
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Contact:
- Valerie Schwitzgebel
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St. Gallen, Switzerland, 9007
- Recruiting
- Klinik für Endokrinologie, Diabetologie, Osteologie und Stoffwechselerkrankungen, Kantonsspital St.Gallen
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Principal Investigator:
- Michael Brändle, Prof. Dr. med., M.Sc.
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Sub-Investigator:
- Katrin Schimke, Dr. med.
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Zürich, Switzerland, 8091
- Recruiting
- Klinik für Endokrinologie, Diabetologie und Klinische Ernährung, Universitätsspital Zürich
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Principal Investigator:
- Roger Lehmann, Prof. Dr. med.
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Sub-Investigator:
- Jan Krützfeld, Prof. Dr. med.
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Sub-Investigator:
- Giatgen Spinas, Prof. Dr. med.
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Sub-Investigator:
- Philipp Gerber, PD Dr. med.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age > 18 years
- Diagnosis of diabetes mellitus according to ADA criteria
- Informed consent
Exclusion Criteria:
- Patients with gestational diabetes mellitus, patients unable to give informed consent, legally incompetent or incapable to comply with the study terms and conditions as well as patients with significantly reduced life expectancy (<1 year) will be excluded
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
Patients with type 1 or type 2 diabetes mellitus, monogenetic diabetes, pancreatogenic diabetes, drug-induced diabetes, other forms
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mortality
Time Frame: annually
|
annually
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Macrovascular morbidity
Time Frame: annually
|
annually
|
Microvascular morbidity
Time Frame: annually
|
annually
|
Diabetes related influence on quality of Life
Time Frame: annually
|
annually
|
Collaborators and Investigators
Investigators
- Principal Investigator: Michael Brändle, Prof., Div. of Endocrinology, Diabetes and Clinical Nutrition, Kantonsspital St. Gallen
- Principal Investigator: Markus Laimer, PD Dr. med., Div. of Endocrinology, Diabetes and Clinical Nutrition, University Hospital Bern
- Principal Investigator: Roger Lehmann, Prof., Div. of Endocrinology, Diabetes and Clin. Nutrition, University Hospital Zürich
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EKSG 01/114/L
- EKSG 01/114/3B (Other Identifier: EC SG (previous number))
- KEK 025/10 (Other Identifier: EC Bern (previous number))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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