Swiss Diabetes Pilot-Study (SwissDiab)
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.
|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|
- Mortality [ Time Frame: annually ] [ Designated as safety issue: No ]
- 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
|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
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.
- 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01179815
|Div. of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital||Recruiting|
|Bern, Switzerland, 3010|
|Contact: Peter Diem, Prof +41 31 632 40 70 email@example.com|
|Principal Investigator: Peter Diem, Prof|
|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|