Swiss Diabetes Pilot-Study - Full Text View

Purpose

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.

Condition
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

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Diabetes Type 2

U.S. FDA Resources

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

Primary Outcome Measures:

Mortality [ Time Frame: annually ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Macrovascular morbidity [ Time Frame: annually ] [ Designated as safety issue: No ]
Microvascular morbidity [ Time Frame: annually ] [ Designated as safety issue: No ]
Quality of Life [ Time Frame: annually ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Serum

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)

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 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.

Objective

To design and implement an internet-based database for data collection and management at two tertiary hospitals.
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.
To compare data with data from the historic Swiss sub-cohort of the WHO Multinational Study of Vascular Disease if possible.

Methods

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Gestational diabetes mellitus

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01179815

Locations

Switzerland
Div. of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital	Recruiting
Bern, Switzerland, 3010
Contact: Peter Diem, Prof +41 31 632 40 70 peter.diem@insel.ch
Principal Investigator: Peter Diem, Prof

Sponsors and Collaborators

University Hospital Inselspital, Berne

Cantonal Hospital of St. Gallen

Investigators

Principal Investigator:	Peter Diem, Prof	Div. of Endocrinology, Diabetes and Clinical Nutrition, University Hospital Bern
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:	Katrin Schimke, MD	Div. of Endocrinology, Diabetes and Clinical Nutrition, Kantonsspital St. Gallen
Principal Investigator:	Felix Kühn, MD	Div. of Endocrinology, Diabetes and Clinical Nutrition, University Hospital Bern

More Information

No publications provided

Responsible Party:	Peter Diem, SwissDiab
ClinicalTrials.gov Identifier:	NCT01179815 History of Changes
Other Study ID Numbers:	KEK 025/10
Study First Received:	August 10, 2010
Last Updated:	December 27, 2012
Health Authority:	Switzerland: Independent Local Research Ethic Commission (Ethikkommission)

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

ClinicalTrials.gov processed this record on May 16, 2013

Swiss Diabetes Pilot-Study (SwissDiab)