Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
1500 participants
OBSERVATIONAL
2010-01-31
2099-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
1. 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)
2. 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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Patients with type 1 or type 2 diabetes mellitus, monogenetic diabetes, pancreatogenic diabetes, drug-induced diabetes, other forms
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of diabetes mellitus according to ADA criteria
* Informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cantonal Hospital of St. Gallen
OTHER
University of Zurich
OTHER
Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael Brändle, Prof.
Role: PRINCIPAL_INVESTIGATOR
Div. of Endocrinology, Diabetes and Clinical Nutrition, Kantonsspital St. Gallen
Markus Laimer, PD Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Div. of Endocrinology, Diabetes and Clinical Nutrition, University Hospital Bern
Roger Lehmann, Prof.
Role: PRINCIPAL_INVESTIGATOR
Div. of Endocrinology, Diabetes and Clin. Nutrition, University Hospital Zürich
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universitätspoliklinik für Endokrinologie, Diabetologie und Klinische Ernährung, Inselspital Bern
Bern, , Switzerland
Service d'endocrinologie, diabétologie et métabolisme
Lausanne, , Switzerland
Klinik für Endokrinologie, Diabetologie, Osteologie und Stoffwechselerkrankungen, Kantonsspital St.Gallen
Sankt Gallen, , Switzerland
Klinik für Endokrinologie, Diabetologie und Klinische Ernährung, Universitätsspital Zürich
Zurich, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Valerie Schwitzgebel
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EKSG 01/114/3B
Identifier Type: OTHER
Identifier Source: secondary_id
KEK 025/10
Identifier Type: OTHER
Identifier Source: secondary_id
EKSG 01/114/L
Identifier Type: -
Identifier Source: org_study_id