Validation of Existing Diabetes Risk Models in a Swedish Population

NCT ID: NCT05609266

Last Updated: 2022-12-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 115642 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1990-01-31
• Study Completion Date: 2020-12-31

Brief Summary

The goal of this observational study is to validate existing non-invasive diabetes clinical prediction models in a Swedish population. The main question it aims to answer is: how well 11 existing models will perform in predicting incident type 2 diabetes in participants from the Västerbotten Intervention programme (VIP). Participants in VIP are residents of Västerbotten that are invited for a comprehensive health screening at 30- (until 1995), 40-, 50-, and 60-years of age.

Detailed Description

Several type 2 diabetes risk prediction models have been developed but how it will perform in a Swedish population is not known. No diabetes risk prediction model is routinely used in Sweden. The aim of this study is therefore, to validate 11 non-invasive models and to evaluate the performance to predict incident type 2 diabetes in a Swedish population. A population-based cohort from the Västerbotten Intervention programme (VIP) from 1990 to 2020 will be the validation sample. Incident type 2 diabetes within 10-years of follow-up, will be determined by oral glucose tolerance test or through self-reports. A self-administered questionnaire is completed, and anthropometric, clinical, and biochemical measures are obtained at each of the health screening visits. In the statistical analysis the overall performance of the models will be compared using the Brier score. In addition. discrimination and calibration of all the models will be evaluated. Recalibration of models will be done.

Conditions

Type2diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• At least one visit within the Västerbotten Intervention program

Exclusion Criteria

• Prevalent diabetes at first visit defined by a fasting capillary plasma glucose >7mmol/L, a 2-hour capillary plasma glucose of ≥12.2 mmol/L or self-reported history of diabetes

• Minimum Eligible Age: 28 Years
• Maximum Eligible Age: 62 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Cambridge

OTHER

Sponsor Role: collaborator

Umeå University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olov Rolandsson, MD

Role: PRINCIPAL_INVESTIGATOR

Umeå University

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Related Links

https://apps.who.int/iris/handle/10665/66040

WHO Definition, diagnosis and classification of diabetes mellitus and its complications

Other Identifiers

2022-VIPRisk_Valexist

Identifier Type: -

Identifier Source: org_study_id