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The Impact of a Diabetes Risk Prediction Model in Primary Care.

G

German Diabetes Center

Status

Completed

Conditions

Primary Prevention
Type 2 Diabetes Mellitus

Treatments

Other: external validated risk prediction model

Study type

Interventional

Funder types

Other

Identifiers

NCT03234322
DRT-Study

Details and patient eligibility

About

Little evidence exists on the impact of diabetes risk scores, e.g. on physicians and patient's behavior, perceived risk of persons, shared-decision making and particularly on patient´s health. The aim of this study is to investigate the impact of a non-invasive diabetes risk prediction model in the primary health care setting as component of routine health checks on change in physical activity.

Full description

Diabetes risk scores are predictive models to estimate the probability for an individual to develop diabetes within a defined time period. In the last years, many diabetes risk prediction models were developed worldwide. It has been proposed that using diabetes risk scores as first step of diabetes screening is more practical than blood glucose tests as the latter are time consuming and costly. Given the rapid development of diabetes risk scores and a simultaneous reluctance of primary care physicians (PCPs) to implement diabetes risk scores in everyday practice, there is an urgent need to expand our knowledge of the impact of diabetes risk scores in the primary health care setting. Thus, the aim of the study is to investigate the impact of a non-invasive risk prediction model in the primary health care setting as component of routine health checks on change in physical activity.

Enrollment

315 patients

Sex

All

Ages

35+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for participation of medical practitioners:

  • general practitioners, medical practitioners and internists working as general practitioners with and without further training in diabetology according to German Diabetes Association standards
  • provide the routine health check

Exclusion criteria for participation of medical practitioners:

  • treat exclusively patients with private insurance
  • treat exclusively diabetes patients in a specialized medical practice

Inclusion criteria for participation of participants

  • appointment for the routine health check
  • insured in statutory health insurance
  • age > 35 years
  • Body Mass Index (BMI) of ≥ 27 kg/m2

Exclusion criteria for participation of participants

  • type 1 or type 2 diabetes diagnosis or already abnormal blood glucose level (fasting glucose ≥ 126 mg/dl or 2 hours oral glucose tolerance test (oGTT) ≥ 200mg/dl or glycated hemoglobin (HbA1c) ≥6,5%) before the routine health check
  • no sufficient German language skills to fill in the questionnaires
  • presence of an incurable disease with a prognosis of less than one year
  • severe mental illness or dementia
  • severe underlying disease, which largely impairs physical activity
  • pregnancy
  • participation in another clinical study 30 days before study inclusion

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

315 participants in 2 patient groups

Intervention group
Experimental group
Description:
In the intervention group the routine health check is expanded by usage of a non-invasive diabetes risk score.
Treatment:
Other: external validated risk prediction model
Control group
No Intervention group
Description:
In the control group the routine health check is conducted.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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