Validation of Existing Diabetes Risk Models in a Swedish Population

Validation of Non-invasive Risk Models for Prediction of Incident Type 2 Diabetes in a Swedish Population

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05609266

Enrollment

115642

Registered

2022-11-08

Start date

1990-01-31

Completion date

2020-12-31

Last updated

2022-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type2diabetes

Keywords

Non-invasive prediction model, Incident diabetes, Validation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

28 Years to 62 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Incident type 2 diabetes	10-years	Determined by a fasting capillary plasma glucose of ≥7 mmol/L or a 2-hour capillary plasma glucose of ≥12.2 mmol/L, or self-reported

Outcome results