Diabetes MellitusSwissDiabNCT01179815
Swiss Diabetes Registry - SwissDiab Study
An observational study of Diabetes Mellitus, run by Insel Gruppe AG, University Hospital Bern at 4 sites in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 1,500 participants
- Where
- 4 sitesSwitzerland
- Study dates
- Jan 2010to Jan 2099
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with diabetes above age 18 are eligible for this study, irrespective of type, duration of diabetes or treatment. Diabetes will be defined according to the current diagnosis criteria suggested by the American Diabetes Association (fasting plasma glucose ≥ 7mmol/L, occasional plasma glucose ≥11.1mmol/L (plus typical symptoms), a 2hour plasma glucose of ≥11.1mmol/L after a 75g oral glucose tolerance test, or a HbA1c ≥ 6.5%), but patients under treatment with ≥2 oral hypoglycemic agents (OHA) and/or insulin in the absence of proof of a diagnosis by fasting, random plasma glucose or oral glucose tolerance test will also be included. The type of diabetes will be diagnosed clinically in most cases. In equivocal cases classification will be based on previously reported criteria with the assistance of laboratory test results.
Who may be able to join
- Age > 18 years
- Diagnosis of diabetes mellitus according to ADA criteria
- Informed consent
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland4 sites, 4 recruiting
- Recruiting
Universitätspoliklinik für Endokrinologie, Diabetologie und Klinische Ernährung, Inselspital Bern
Bern, 3010
Markus Laimer, PD Dr. med., +41 31 632 30 62, Markus.Laimer@insel.ch
Christoph Stettler, Prof., +41 31 632 40 70, christoph.stettler@insel.ch
- Recruiting
Service d'endocrinologie, diabétologie et métabolisme
Lausanne
Valerie Schwitzgebel
- Recruiting
Klinik für Endokrinologie, Diabetologie, Osteologie und Stoffwechselerkrankungen, Kantonsspital St.Gallen
Sankt Gallen, 9007
Michael Brändle, Prof. Dr. med., M.Sc.
Katrin Schimke, Dr. med.
- Recruiting
Klinik für Endokrinologie, Diabetologie und Klinische Ernährung, Universitätsspital Zürich
Zurich, 8091
Roger Lehmann, Prof. Dr. med.
Jan Krützfeld, Prof. Dr. med.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Keywords
- Patients with type 1 or type 2 diabetes mellitus, Monogenetic diabetes, Pancreatogenic diabetes,, Drug-induced diabetes, other forms, Cohort Studies
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
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 | Patients with type 1 or type 2 diabetes mellitus, monogenetic diabetes, pancreatogenic diabetes, drug-induced diabetes, other forms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: annually
Secondary outcomes (3)
Macrovascular morbidity
Measured: annually
Microvascular morbidity
Measured: annually
Diabetes related influence on quality of Life
Measured: annually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2099 (estimated)
- Study completionJan 2099 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Cantonal Hospital of St. Gallen, University of Zurich
- Responsible party
- Sponsor
- Investigators
- Michael Brändle, Prof., Principal investigator, Div. of Endocrinology, Diabetes and Clinical Nutrition, Kantonsspital St. GallenMarkus Laimer, PD Dr. med., Principal investigator, Div. of Endocrinology, Diabetes and Clinical Nutrition, University Hospital BernRoger Lehmann, Prof., Principal investigator, Div. of Endocrinology, Diabetes and Clin. Nutrition, University Hospital Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179815
- Sponsor's protocol ID
- EKSG 01/114/L
- Other IDs
- EKSG 01/114/3B, KEK 025/10
- Acronym
- SwissDiab
- Status last verified
- Jun 2026
- First submitted
- 10 Aug 2010
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swiss Diabetes Registry - SwissDiab Study, a Prospective Cohort Study of Patients With Diabetes in Switzerland
- ClinicalTrials.gov ID
- NCT01179815
- Acronym / sponsor ID
- SwissDiab / EKSG 01/114/L
- Conditions
- Diabetes Mellitus
- Keywords
- Patients with type 1 or type 2 diabetes mellitus, Monogenetic diabetes, Pancreatogenic diabetes,, Drug-induced diabetes, other forms, Cohort Studies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Cantonal Hospital of St. Gallen, University of Zurich
- Study start
- Jan 2010
- Primary completion
- Jan 2099 (estimated)
- Study completion
- Jan 2099 (estimated)
- First posted
- 11 Aug 2010 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with type 1 or type 2 diabetes mellitus, monogenetic diabetes, pancreatogenic diabetes, drug-induced diabetes, other forms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with diabetes above age 18 are eligible for this study, irrespective of type, duration of diabetes or treatment. Diabetes will be defined according to the current diagnosis criteria suggested by the American Diabetes Association (fasting plasma glucose ≥ 7mmol/L, occasional plasma glucose ≥11.1mmol/L (plus typical symptoms), a 2hour plasma glucose of ≥11.1mmol/L after a 75g oral glucose tolerance test, or a HbA1c ≥ 6.5%), but patients under treatment with ≥2 oral hypoglycemic agents (OHA) and/or insulin in the absence of proof of a diagnosis by fasting, random plasma glucose or oral glucose tolerance test will also be included. The type of diabetes will be diagnosed clinically in most cases. In equivocal cases classification will be based on previously reported criteria with the assistance of laboratory test results.
Key inclusion criteria (3 listed)
- Age > 18 years
- Diagnosis of diabetes mellitus according to ADA criteria
- Informed consent
Key exclusion criteria (1 listed)
- 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
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
Mortality
Time frame: annually
3 secondary outcomes
Macrovascular morbidity
Time frame: annually
Microvascular morbidity
Time frame: annually
Diabetes related influence on quality of Life
Time frame: annually
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Michael Brändle, Prof. principal investigator
Div. of Endocrinology, Diabetes and Clinical Nutrition, Kantonsspital St. Gallen
Markus Laimer, PD Dr. med. principal investigator
Div. of Endocrinology, Diabetes and Clinical Nutrition, University Hospital Bern
Roger Lehmann, Prof. principal investigator
Div. of Endocrinology, Diabetes and Clin. Nutrition, University Hospital Zürich
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Insel Gruppe AG, University Hospital Bern at 4 sites in 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 3 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: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Markus Laimer, PD Dr. med. (+41 31 632 30 62, Markus.Laimer@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: annually). It is what the study was designed to measure, not a finding.
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 11 Jun 2026.