Swiss Diabetes Registry - SwissDiab Study

NCT01179815 | Recruiting DMC

• 3 other identifiers: EKSG 01/114/LEKSG 01/114/3BKEK 025/10
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Diabetes Mellitus

Keywords

Patients with type 1 or type 2 diabetes mellitus; Monogenetic diabetes; Pancreatogenic diabetes,; Drug-induced diabetes, other forms; Cohort Studies

Outcome Measures

Primary Outcomes (1)

• Mortality

  annually

Secondary Outcomes (3)

• Macrovascular morbidity

  annually

• Microvascular morbidity

  annually

• Diabetes related influence on quality of Life

  annually

Study Arms (1)

1

Patients with type 1 or type 2 diabetes mellitus, monogenetic diabetes, pancreatogenic diabetes, drug-induced diabetes, other forms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Cantonal Hospital of St. Gallen: collaborator
• University of Zurich: collaborator

Study Sites (4)

Universitätspoliklinik für Endokrinologie, Diabetologie und Klinische Ernährung, Inselspital Bern

Bern, 3010, Switzerland

RECRUITING

Service d'endocrinologie, diabétologie et métabolisme

Lausanne, Switzerland

RECRUITING

Klinik für Endokrinologie, Diabetologie, Osteologie und Stoffwechselerkrankungen, Kantonsspital St.Gallen

Sankt Gallen, 9007, Switzerland

RECRUITING

Klinik für Endokrinologie, Diabetologie und Klinische Ernährung, Universitätsspital Zürich

Zurich, 8091, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and full blood samples

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Markus Laimer, PD Dr. med.

CONTACT

+41 31 632 30 62; Markus.Laimer@insel.ch

Christoph Stettler, Prof.

CONTACT

+41 31 632 40 70; christoph.stettler@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2010
• First Posted: August 11, 2010
• Study Start: January 1, 2010
• Primary Completion (Estimated): January 1, 2099
• Study Completion (Estimated): January 1, 2099
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (4)