Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Swiss Diabetes Registry - SwissDiab Study (SwissDiab)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2017 by University Hospital Inselspital, Berne
Sponsor:
Collaborators:
Cantonal Hospital of St. Gallen
University of Zurich
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01179815
First received: August 10, 2010
Last updated: May 1, 2017
Last verified: May 2017
  Purpose

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.


Condition
Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Swiss Diabetes Registry - SwissDiab Study, a Prospective Cohort Study of Patients With 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
Serum and full blood samples

Estimated Enrollment: 1500
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)
Groups/Cohorts
1
Patients with type 1 or type 2 diabetes mellitus, monogenetic diabetes, pancreatogenic diabetes, drug-induced diabetes, other forms

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

  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.

  Eligibility

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 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.
Criteria

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
  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 ClinicalTrials.gov identifier: NCT01179815

Contacts
Contact: Christoph Stettler, Prof. +41 31 632 40 70 christoph.stettler@insel.ch

Locations
Switzerland
Universitätspoliklinik für Endokrinologie, Diabetologie und Klinische Ernährung, Inselspital Bern Recruiting
Bern, Switzerland, 3010
Contact: Christoph Stettler, Prof    +41 31 632 40 70    christoph.stettler@insel.ch   
Principal Investigator: Christoph Stettler, Prof.         
Sub-Investigator: Peter Diem, Prof.         
Sub-Investigator: Katja Müller-Fischer, Dr. med.         
Sub-Investigator: Markus Laimer, PD Dr. med.         
Klinik für Endokrinologie, Diabetologie, Osteologie und Stoffwechselerkrankungen, Kantonsspital St.Gallen Recruiting
St. Gallen, Switzerland, 9007
Principal Investigator: Michael Brändle, Prof. Dr. med., M.Sc.         
Sub-Investigator: Katrin Schimke, Dr. med.         
Klinik für Endokrinologie, Diabetologie und Klinische Ernährung, Universitätsspital Zürich Recruiting
Zürich, Switzerland, 8091
Principal Investigator: Roger Lehmann, Prof. Dr. med.         
Sub-Investigator: Jan Krützfeld, Prof. Dr. med.         
Sub-Investigator: Giatgen Spinas, Prof. Dr. med.         
Sub-Investigator: Philipp Gerber, PD Dr. med.         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Cantonal Hospital of St. Gallen
University of Zurich
Investigators
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: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01179815     History of Changes
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) )
Study First Received: August 10, 2010
Last Updated: May 1, 2017

Keywords provided by University Hospital Inselspital, Berne:
Patients with type 1 or type 2 diabetes mellitus
Monogenetic diabetes
Pancreatogenic diabetes,
Drug-induced diabetes, other forms
Cohort Studies

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 25, 2017