An observational study in Diabetes Mellitus, Type 2 and Diabetes, Gestational, sponsored by University of Copenhagen. Enrolling by invitation at 5 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-17.
Sponsored by University of Copenhagen · Observational
The aim of TRANSLATE is to implement genetic information directly into patient care to improve diagnosis and treatment of non-autoimmune diabetes. This project is the first large-scale implementation of systematic genetic testing within a common, non-communicable, chronic disease in Denmark, and will spearhead efforts to advance personalized medicine in Denmark.
The project will contribute to establishing technology, workflow, and evidence on how to implement and communicate actionable genetic information to clinicians and patients in a generalized format. These developments are pivotal for personalized medicine to reach broader clinical application.
The TRANSLATE project is an integrative project with multifaceted goals, that can be broken down into two main columns. The foundation for both columns is the WGS analysis in a clinical diagnostic setting in order to guide patient treatment. Patients are not randomized and the inclusion and exclusion criteria are deliberately broad and minimal, respectively.
The first column is the clinical development project, which seeks to complete a novel diagnostic process. This column will develop new pipelines and uncover barriers and challenges associated with gene-based precision medicine to facilitate sustainable implementation of gene-based precision medicine beyond the TRANSLATE project.
During the project, we wish to focus on potential barriers against a broad application of gene-based precision medicine in a common disease. These may include:
The second column is a register-based research project in which we will utilize data from the patients to advance gene-based precision medicine. In this column we will both address how to establish comprehensive research infrastructure, as well as answer specific research questions. We will address how to combine and harmonize genetic data with other Danish registry sources. We will use the newly established methodologies to focus on the following research areas with respect to patient stratification, clinical trajectories, complication development, and other clinically relevant outcomes:
842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.
This study's planned enrollment of 6,500 is above the median of 200 across 269 observational studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients in the target groups with non-autoimmune/non-T1D attending SDCC or pregnant women with gestational diabetes attending one of the obstetric clinics in the project will be offered a genetic test.
Exclusion Criteria:
Any case of non-T1D defined as: * Debut \>30 years of age OR * Debut \<30 years of age AND negative autoantibodies treated at Steno Diabetes Center Copenhagen
Other: Whole genome sequencing
Any case of diabetes diagnosed in pregnancy treated at the following obstetric clinics in the Capital Region in Denmark: Rigshospitalet, Nordsjællands Hospital, Herlev Hospital, Hvidovre Hospital
Other: Whole genome sequencing
Each participant will have WGS performed in order to report on clinically actionable genetic variation in diabetes.
Also known as: WGS
Selection of clinically actionable genetic variation in diabetes
Using mixed methods such as gene burden investigations, workgroups, interviews, etc. challenges related to the selection of clinically actionable genetic variants and automation of interpretation/translation will be delineated.
Time frame: Until final patient inclusion (May 2025) + 2 years (May 2027)
Ethical concerns regarding the application and utility of genetic information
The project will address how patients, clinicians, technicians etc. shape their understanding of the utility and challenges associated with gene-based precision medicine using ethnographic methods such as field observations and semi-structured interviews.
Time frame: Until final patient inclusion (May 2025) + 2 years (May 2027)
Validity and limitations of current computational pipelines
By comparing computational and analytical methods, the project will investigate the validity and limitations of different computational pipelines. This includes handling of single nucleotide variants, as well as structural variation.
Time frame: Until final patient inclusion (May 2025) + 2 years (May 2027)
Interoperability of IT systems and databases
The project will address the flow of data to and from clinical end-users, through centralized databases, both with respect to how the data flow is perceived by users and potential challenges, and how interoperability can be improved to enhance clinical utility. The project will also address how to harmonize data from different sources.
Time frame: Until final patient inclusion (May 2025) + 2 years (May 2027)
Impact on clinical decision-making and clinical trajectories
Using mixed methods such as mapping of clinical trajectories through clinical registries and qualitative methods such as interviews, workgroups, etc., the project will investigate how implementation of gene-based precision diabetes impacts clinical decision making.
Time frame: Until final patient inclusion (May 2025) + 2 years (May 2027)
Plan to share: No — Data will be reported to Danish National Genome Center after completion.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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University of Copenhagen