Diabetes Mellitus, Type 2TRANSLATENCT05368220
Translating Genetic Knowledge Into Clinical Care in Non-Autoimmune Diabetes
An observational study of Diabetes Mellitus, Type 2 and Diabetes, Gestational, run by University of Copenhagen at 5 sites in Denmark.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetes, Gestational
- What is being tested?
- Whole genome sequencing
- How many people
- 6,500 participants
- Where
- 5 sitesDenmark
- Study dates
- 6 May 2022to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Any case of non-T1D defined as debut >30 years of age, OR debut <30 years of age AND negative autoantibodies
- Any case of diabetes diagnosed in pregnancy (obstetric departments)
Who cannot join
- Age <18 years
- Inability to provide informed consent
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Denmark5 sites
Rigshospitalet
Copenhagen
Herlev Hospital
Herlev
Steno Diabetes Center Copenhagen
Herlev
Hillerød Hospital
Hillerød
Hvidovre Hospital
Hvidovre
About this study
Official title: TRANSLATE - Translating Genetic Knowledge Into Clinical Care in Non-Autoimmune Diabetes
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.
Read the detailed description
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:
- Challenges pertaining to the selection of variants that are deemed clinically actionable, automation of genetic interpretation/translation, and the feasibility of large-scale precision medicine implementation
- Ethical concerns of patients, clinicians, and other technicians with regard to the application and utility of genetic information
- Validity and limitations of current computational pipelines for variant calling including the calling of structural variants and aggregate genetic tools
- Challenges regarding the interoperability of IT systems and databases nationally in Denmark, specifically how central databases can be linked to clinical end-users
- How implementation of genetic analyses affects clinical decision-making and/or clinical trajectories, both qualitatively and quantitatively
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:
- Polygenic risk scores
- Machine learning algorithms
- Combined polygenic and monogenic traits
- Non-coding variation
- Structural variation, specifically exon deletions and duplications, which have previously been shown as a cause of monogenic diabetes
- Conditions
- Diabetes Mellitus, Type 2, Diabetes, Gestational
- Being tested
- Whole genome sequencing
- Keywords
- Precision medicine, Personalized medicine, Genetics
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole genome sequencingOther
Also called WGS
Each participant will have WGS performed in order to report on clinically actionable genetic variation in diabetes.
| Study group | Role | What they receive |
|---|---|---|
| Patients with non-autoimmune diabetes (type 2 diabetes) | 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 Receives: Other: Whole genome sequencing | |
| Patients with gestational diabetes | 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 Receives: Other: Whole genome sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Until final patient inclusion (May 2025) + 2 years (May 2027)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start6 May 2022
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 6,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Steno Diabetes Center Copenhagen, BGI Europe, Intomics A/S, Copenhagen University Hospital, Rigshospitalet, Danish National Genome Center, Nordsjaellands Hospital, Herlev Hospital, Hvidovre University Hospital
- Responsible party
- Principal investigator, Torben Hansen, University of Copenhagen
- Investigators
- Torben Hansen, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368220
- Sponsor's protocol ID
- 9090-00078B
- Acronym
- TRANSLATE
- Status last verified
- May 2022
- First submitted
- 2 May 2022
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be reported to Danish National Genome Center after completion.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRANSLATE - Translating Genetic Knowledge Into Clinical Care in Non-Autoimmune Diabetes
- ClinicalTrials.gov ID
- NCT05368220
- Acronym / sponsor ID
- TRANSLATE / 9090-00078B
- Conditions
- Diabetes Mellitus, Type 2, Diabetes, Gestational
- Keywords
- Precision medicine, Personalized medicine, Genetics
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 6,500 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Steno Diabetes Center Copenhagen, BGI Europe, Intomics A/S, Copenhagen University Hospital, Rigshospitalet, Danish National Genome Center, Nordsjaellands Hospital, Herlev Hospital, Hvidovre University Hospital
- Study start
- 6 May 2022 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Challenges pertaining to the selection of variants that are deemed clinically actionable, automation of genetic interpretation/translation, and the feasibility of large-scale precision medicine implementation
- Ethical concerns of patients, clinicians, and other technicians with regard to the application and utility of genetic information
- Validity and limitations of current computational pipelines for variant calling including the calling of structural variants and aggregate genetic tools
- Challenges regarding the interoperability of IT systems and databases nationally in Denmark, specifically how central databases can be linked to clinical end-users
- How implementation of genetic analyses affects clinical decision-making and/or clinical trajectories, both qualitatively and quantitatively
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:
- Polygenic risk scores
- Machine learning algorithms
- Combined polygenic and monogenic traits
- Non-coding variation
- Structural variation, specifically exon deletions and duplications, which have previously been shown as a cause of monogenic diabetes
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with non-autoimmune diabetes (type 2 diabetes) | – | Other: Whole genome sequencingAny 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 |
| Patients with gestational diabetes | – | Other: Whole genome sequencingAny 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Any case of non-T1D defined as debut >30 years of age, OR debut <30 years of age AND negative autoantibodies
- Any case of diabetes diagnosed in pregnancy (obstetric departments)
Key exclusion criteria (2 listed)
- Age <18 years
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole genome sequencingAlso: WGSEach participant will have WGS performed in order to report on clinically actionable genetic variation in diabetes. | Other | Patients with gestational diabetes, Patients with non-autoimmune diabetes (type 2 diabetes) |
Primary outcome
Selection of clinically actionable genetic variation in diabetes
Time frame: Until final patient inclusion (May 2025) + 2 years (May 2027)
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.
Ethical concerns regarding the application and utility of genetic information
Time frame: Until final patient inclusion (May 2025) + 2 years (May 2027)
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.
Validity and limitations of current computational pipelines
Time frame: Until final patient inclusion (May 2025) + 2 years (May 2027)
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.
Interoperability of IT systems and databases
Time frame: Until final patient inclusion (May 2025) + 2 years (May 2027)
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.
Impact on clinical decision-making and clinical trajectories
Time frame: Until final patient inclusion (May 2025) + 2 years (May 2027)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data will be reported to Danish National Genome Center after completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Torben Hansen, PhD principal investigator
University of Copenhagen
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Diabetes, Gestational, run by University of Copenhagen at 5 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Selection of clinically actionable genetic variation in diabetes (time frame: Until final patient inclusion (May 2025) + 2 years (May 2027)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.