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Swiss Diabetes Pilot-Study (SwissDiab)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by University Hospital Inselspital, Berne
Cantonal Hospital of St. Gallen
Information provided by:
University Hospital Inselspital, Berne Identifier:
First received: August 10, 2010
Last updated: November 23, 2015
Last verified: November 2015

Currently, the estimated number of people with diabetes mellitus is around 250 million. 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 SwissDiab Pilot Study is a prospective cohort study aiming at the collection of data on diabetic patients (type 1 and type 2) at two tertiary hospitals in Switzerland. 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 diabetic patients in Switzerland.

Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Swiss Diabetes Pilot-Study, a Prospective Cohort Study of Patients With Type 1 and Type 2 Diabetes in Switzerland

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Mortality [ Time Frame: annually ]

Secondary Outcome Measures:
  • Macrovascular morbidity [ Time Frame: annually ]
  • Microvascular morbidity [ Time Frame: annually ]
  • Quality of Life [ Time Frame: annually ]

Biospecimen Retention:   Samples Without DNA

Estimated Enrollment: 1000
Study Start Date: January 2010
Estimated Study Completion Date: January 2099
Estimated Primary Completion Date: January 2099 (Final data collection date for primary outcome measure)
Patients with type 1 or type 2 diabetes mellitus, monogenetic diabetes, pancreatogenic diabetes, drug-induced diabetes, other forms

Detailed Description:


Currently, approximately 250 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 2007 at $174 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.


  1. To design and implement an internet-based database for data collection and management at two tertiary hospitals.
  2. To evaluate the current and future standard of care of patients with diabetes mellitus (type 1 and type 2), the distribution of micro- and macrovascular complications, the use of therapeutics and devices as well as aspects of costs and quality of life.
  3. To compare data with data from the historic Swiss sub-cohort of the WHO Multinational Study of Vascular Disease if possible.


After obtaining informed consent, patients with diabetes mellitus willing to participate will be invited to an initial comprehensive assessment (baseline) performed at either of the two cantonal study centers (Inselspital Bern or Kantonsspital St. Gallen). 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with diabetes above age 18 are eligible for this study, irrespective of 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.

Inclusion Criteria:

  • Age > 18 years
  • Diagnosis of diabetes mellitus according to ADA criteria
  • Informed consent

Exclusion Criteria:

  • Gestational diabetes mellitus
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01179815

Contact: Christoph Stettler, Prof. +41 31 632 40 70

Div. of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital Recruiting
Bern, Switzerland, 3010
Contact: Christoph Stettler, Prof    +41 31 632 40 70   
Principal Investigator: Christoph Stettler, Prof.         
Sub-Investigator: Peter Diem, Prof.         
Sub-Investigator: Katja Müller-Fischer, Dr. med.         
Sub-Investigator: Markus Laimer, PD Dr. med.         
Div. of Endocrinology, Diabetes and Clinical Nutrition, St. Gallen Recruiting
St. Gallen, Switzerland, 9007
Principal Investigator: Michael Brändle, Prof.         
Sub-Investigator: Katrin Schimke, Dr. med.         
Div. of Endocrinology, Diabetes and Clin. Nutrition, University Hospital Zürich Recruiting
Zürich, Switzerland, 8091
Principal Investigator: Roger Lehmann, Prof.         
Sub-Investigator: Jan Krützfeld, Prof.         
Sub-Investigator: Giatgen Spinas, Prof.         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Cantonal Hospital of St. Gallen
Principal Investigator: Michael Brändle, Prof Div. of Endocrinology, Diabetes and Clinical Nutrition, Kantonsspital St. Gallen
Principal Investigator: Christoph Stettler, Prof 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
  More Information

Responsible Party: Peter Diem, SwissDiab Identifier: NCT01179815     History of Changes
Other Study ID Numbers: KEK 025/10
Study First Received: August 10, 2010
Last Updated: November 23, 2015

Keywords provided by University Hospital Inselspital, Berne:
Diabetes mellitus, Type 1
Diabetes mellitus, Type 2
Cohort Studies

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on April 21, 2017